Multiple Packaging Engineer positions available.  Title and level will be determined based on candidate experience.

Job Summary:

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.

Job Facts:

Roche Professional Diagnostics provides integrated, high-performance analytical systems to optimize laboratory management from pre-analytical to post-analytical processes. We develop high quality solutions for diagnostics laboratories - from analyzers and test reagents to work-flow solutions. To maintain its leadership in technology and quality, Roche minimizes third party products with more than 75 percent of its assay portfolio developed and manufactured in-house. Roche is a successful company that can offer exciting career opportunities. We encourage and support your development in areas of your interest which will prepare you for the next level in your career path. We know that people are responsible for our success and we value our employees. Our commitment is to create a work environment where feeling valued, respected, and empowered is a daily experience. 

This is a field based role - the territory is Lansing, Michigan. You must live within 50 miles of the territory.

The Opportunity:

As an Account Executive- Point of Care, you will be responsible for total account management and selling the full Roche Point of Care portfolio. This includes a range of selling skills such as positioning a differentiated Molecular Point of Care technology into the Hospital Laboratory environment and associated physician office labs, with each account have unique needs and buying patterns. As part of the Roche Point of Care portfolio you will be positioning IT solutions that will connect instruments across the IHN continuum of care in both inpatient and outpatient settings. This position requires conducting presentations and business reviews to potential customers thereby demonstrating in-depth knowledge of our product line, as well as relevant healthcare/industry trends including related products or services. Additionally, you will:

• Generate new customer demand within the IHN segment across the full portfolio of POC products.

• Penetrate complex and large IHN accounts to gain access to and favor with key decision makers and all buying influence

• Translate customer needs into internal action to meet those needs while balancing key business priorities and goals

• Balance the need to advocate for your customers while also demonstrating the drive and ability to negotiate and achieve strong business results for Roche.

• Demonstrate strong clinical and financial acumen with a demonstrated ability to understand customer needs and align Roche POC products to an evolving market within the IHN segment.

• Develop territory-specific executional strategies to consistently meet and exceed sales targets.

• Effectively utilize outcomes from workflow analysis and impact studies to provide competitive differentiation and value to the overall customer solution. Provide in-depth technical expertise regarding assigned product lines.

• Utilize competitive, customer, and product knowledge to establish competitive barriers to market penetration by positioning Roche Professional Diagnostic's solutions. Assist customers in achieving defined business/technical and personal goals. These responsibilities will include pre & post analysis review.

• Work cross functionally with internal colleagues and peers to share information and best practices while remaining actively involved in industry/customer organizations that impact business.

• Deliver tailored presentations specific to customer needs incorporating the outcome data from the various process analysis. Conduct system demonstrations & presentations where applicable; Road Shows, VIPS, etc.

• Preferred experience in the Point of Care diagnostic and Integrated Health Network space.

Who you are:

•        Bachelor’s degree or equivalent experience

•        3+ years relevant sales or equivalent experience

•        Participation in an approved accelerated development, fellowship or rotational program may be considered in lieu of experience.

Therapeutic Area Manager (TAM) Lung Pan Tumor

Customer Engagement Model

Since the inception of our organization, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

In order to achieve our vision of delivering ever better health outcomes for patients while lowering overall healthcare costs, we have reinvented our customer engagement model. We started on this journey by listening to our customers within the healthcare industry, and learning from leaders in customer service across a broad range of industries. Through this evaluation, we gained valuable insights on how to optimize how we show up as a partner with our customers. We learned that customers are inundated with information on new treatment options and are overwhelmed by industry professionals vying for their time. We gained understanding of how they prioritize achieving better outcomes for patients at lower costs. And, we learned that we are uniquely positioned to partner with many stakeholders across the healthcare system to achieve this goal due to our robust portfolio.

In our new customer engagement model, we are bringing the full value of our portfolio to where healthcare is delivered - locally. Local healthcare needs are being prioritized and driven versus solely driving a national strategy.

Each ecosystem has been designed around how patients receive care across the country in order to serve the needs of the local communities around us. The ecosystem team will work together to better understand the needs of the ecosystem and put plans in place to address the needs, as well as identify partnership opportunities to advance our shared goals. And, every leader in our new customer engagement model will have direct customer accountabilities in addition to their leadership responsibilities. We believe this is key in maintaining our customer focus and ensuring our model adapts and flexes over time.

As a member of the ecosystem team, you will be able to fully leverage your skills and capabilities alongside the full Genentech portfolio and our rich and robust pipeline. And, the simplicity of our model allows you to do more for your customers and patients, focusing on what is needed locally while also leveraging best practices from other ecosystems.

Join us as we strive to deliver ever better health outcomes for patients, lower overall healthcare costs and reinvent customer engagement in our industry. 

Position Overview:

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision while working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical needs, business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care. 

The TAM is empowered to own the business for their TA within the ecosystem and to optimize opportunities with a focus on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the ecosystem business strategy. The TAM will represent all relevant products and indications within the designated Therapeutic Area. In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient. In addition, they are responsible for collecting ecosystem insights and trends and being a primary conduit between an ecosystem, the Squads and marketing to support the national strategy at a local level. 

Genentech has been a dedicated leader in supporting appropriate patients with our cancer immunotherapy treatments and oncology targeted therapies for many years. Our commitment to the patient is at the forefront of what we do at Genentech, today and tomorrow. With an innovative and robust lung portfolio in research and development, we are confident we will be able to achieve our vision of supporting patients who suffer from devastating disease. Additionally, for more than 20 years, Roche and Genentech have helped lay the scientific groundwork for personalized healthcare with treatments that target the underlying biology of cancer and other diseases. Now we are focused on taking personalized healthcare toward a future in which treatments are targeted to an individual’s needs and unique genetic profile. We are committed to delivering on the promise of personalized healthcare. Join us in this bold mission.

The TAM will represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

Key Accountabilities:

Serve as primary point of contact for their therapeutic area for their customers in the ecosystem. Address and identify opportunities for pulling through ecosystem and therapeutic area squad strategies at the point-of-care. Apply strong understanding of the specific needs of healthcare practitioners and mobilize ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care. Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals  Deliver education to HCPs regarding product information, appropriate use, and dosing and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate. Address product acquisition (contract awareness, etc), and address supply matters through coordination of  distribution issues, and managing spoilage and returns. Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to Healthcare Director (HD), Field Reimbursement Manager (FRM), and Business Engagement Manager as appropriate. Keep abreast of customer and healthcare industry trends. Initiate development actions to constantly adapt and grow capabilities in order to increase impact. Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials. Lead, act and live our Operating Principles in all aspects of work.

Qualifications:

• Business, scientific or clinical degree, Bachelor’s degree level at minimum
• Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required
• 4 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment.
• Proven track record within the Oncology market including ability to succeed in a competitive environment; Lung cancer experience is highly valued / a strong plus
• Clinical nurse or Advanced Practice Nurse (APN) experience highly valued
• Ability to work in an ambiguous environment that adapts and evolves with our healthcare market, is a strong plus
• Proven track record in collaborating with partners in the ecosystem to deliver the most optimal experience for our customers and patients; helping others to better meet or exceed their goals, targets and other responsibilities
• Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals
• Self starter and proven ability to demonstrate ownership of your business; strong business acumen that seeks out relevant information, prioritizes for greatest impact, and applies information to solve complex problems in the ecosystem 
• Ability to assimilate and communicate complex clinical and product information 
• Knowledge of and ability to successfully address operational issues in the delivery of healthcare products to patients, such as reimbursement and access
• Understanding of external laws, codes and company policies that apply to the healthcare industry

Operating Principles

I put the patient first, always. 

I am obsessed with meeting customer needs. 

I act on behalf of the whole company, not just my team. 

I am inclusive.  

I build a culture of trust. 

I have a growth mindset. 

I act with urgency. 

I am accountable. 

I radically simplify and prioritize for impact. 

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

This is a field-based position and overnight travel may be required. This position requires significant driving of a company provided vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Job Facts:

Roche Professional Diagnostics provides integrated, high-performance analytical systems to optimize laboratory management from pre-analytical to post-analytical processes. We develop high quality solutions for diagnostics laboratories - from analyzers and test reagents to work-flow solutions. To maintain its leadership in technology and quality, Roche minimizes third party products with more than 75 percent of its assay portfolio developed and manufactured in-house. Roche is a successful company that can offer exciting career opportunities. We encourage and support your development in areas of your interest which will prepare you for the next level in your career path. We know that people are responsible for our success and we value our employees. Our commitment is to create a work environment where feeling valued, respected, and empowered is a daily experience. 

This is a field based role - the territory is Houston, Texas. You must live within 50 miles of the territory.

The Opportunity:

As an Account Executive- Point of Care, you will be responsible for total account management and selling the full Roche Point of Care portfolio. This includes a range of selling skills such as positioning a differentiated Molecular Point of Care technology into the Hospital Laboratory environment and associated physician office labs, with each account have unique needs and buying patterns. As part of the Roche Point of Care portfolio you will be positioning IT solutions that will connect instruments across the IHN continuum of care in both inpatient and outpatient settings. This position requires conducting presentations and business reviews to potential customers thereby demonstrating in-depth knowledge of our product line, as well as relevant healthcare/industry trends including related products or services. Additionally, you will:

• Generate new customer demand within the IHN segment across the full portfolio of POC products.

• Penetrate complex and large IHN accounts to gain access to and favor with key decision makers and all buying influence

• Translate customer needs into internal action to meet those needs while balancing key business priorities and goals

• Balance the need to advocate for your customers while also demonstrating the drive and ability to negotiate and achieve strong business results for Roche.

• Demonstrate strong clinical and financial acumen with a demonstrated ability to understand customer needs and align Roche POC products to an evolving market within the IHN segment.

• Develop territory-specific executional strategies to consistently meet and exceed sales targets.

• Effectively utilize outcomes from workflow analysis and impact studies to provide competitive differentiation and value to the overall customer solution. Provide in-depth technical expertise regarding assigned product lines.

• Utilize competitive, customer, and product knowledge to establish competitive barriers to market penetration by positioning Roche Professional Diagnostic's solutions. Assist customers in achieving defined business/technical and personal goals. These responsibilities will include pre & post analysis review.

• Work cross functionally with internal colleagues and peers to share information and best practices while remaining actively involved in industry/customer organizations that impact business.

• Deliver tailored presentations specific to customer needs incorporating the outcome data from the various process analysis. Conduct system demonstrations & presentations where applicable; Road Shows, VIPS, etc.

• Preferred experience in the Point of Care diagnostic and Integrated Health Network space.

Who you are:

•        Bachelor’s degree or equivalent experience

•        3+ years relevant sales or equivalent experience

•        Participation in an approved accelerated development, fellowship or rotational program may be considered in lieu of experience.

Colorado applicants not eligible

#LI-KM1

Job Facts:

Roche Professional Diagnostics provides integrated, high-performance analytical systems to optimize laboratory management from pre-analytical to post-analytical processes. We develop high quality solutions for diagnostics laboratories - from analyzers and test reagents to work-flow solutions. To maintain its leadership in technology and quality, Roche minimizes third party products with more than 75 percent of its assay portfolio developed and manufactured in-house. Roche is a successful company that can offer exciting career opportunities. We encourage and support your development in areas of your interest which will prepare you for the next level in your career path. We know that people are responsible for our success and we value our employees. Our commitment is to create a work environment where feeling valued, respected, and empowered is a daily experience. 

This is a field based role - the territory is Charleston, WV/Roanoke, VA. You must live within 50 miles of the territory.

The Opportunity:

As an Account Executive- Point of Care, you will be responsible for total account management and selling the full Roche Point of Care portfolio. This includes a range of selling skills such as positioning a differentiated Molecular Point of Care technology into the Hospital Laboratory environment and associated physician office labs, with each account have unique needs and buying patterns. As part of the Roche Point of Care portfolio you will be positioning IT solutions that will connect instruments across the IHN continuum of care in both inpatient and outpatient settings. This position requires conducting presentations and business reviews to potential customers thereby demonstrating in-depth knowledge of our product line, as well as relevant healthcare/industry trends including related products or services. Additionally, you will:

• Ability to generate new customer demand within the IHN segment across the full portfolio of POC products.

• Effective at penetrating complex and large IHN accounts to gain access to and favor with key decision makers and all buying influence

• Adept at translating customer needs into internal action to meet those needs while balancing key business priorities and goals

• Balances the need to advocate for their customers while also demonstrating the drive and ability to negotiate and achieve strong business results for Roche.

• Strong clinical and financial acumen with a demonstrated ability to understand customer needs and align Roche POC products to an evolving market within the IHN segment.

• Develops territory-specific executional strategies to consistently meet and exceed sales targets.

• Effectively utilize outcomes from workflow analysis and impact studies to provide competitive differentiation and value to the overall customer solution. Provide in-depth technical expertise regarding assigned product lines.

• Utilize competitive, customer, and product knowledge to establish competitive barriers to market penetration by positioning Roche Professional Diagnostic's solutions. Assist customers in achieving defined business/technical and personal goals. These responsibilities will include pre & post analysis review.

• Work cross functionally with internal colleagues and peers to share information and best practices while remaining actively involved in industry/customer organizations that impact business.

• Deliver tailored presentations specific to customer needs incorporating the outcome data from the various process analysis. Conduct system demonstrations & presentations where applicable; Road Shows, VIPS, etc.

• Preferred experience in the Point of Care diagnostic and Integrated Health Network space.

Who you are:

•        Bachelor’s degree or equivalent experience

•        3+ years relevant sales or equivalent experience

•        Participation in an approved accelerated development, fellowship or rotational program may be considered in lieu of experience.

Colorado applicants not eligible.

#LI-KM1

The PV Clinical Associate performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:

•Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with

pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)

oReviews, evaluates and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity / causality and conducts quality review of all cases (as applicable) based on their medical assessment

oPerforms labelling assessment for AE(s) received using clinical knowledge and conducts follow up for all reported cases (as applicable)

•Responsible for Clinical Review of cases processed in-house and by vendors

oPerforms trend analysis of vendor case processing issues and escalates to vendor and USDS management

oResponsible for developing executive summary on the quality trends observed on a quarterly basis

oResponsible for training internal USDS and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis

oResponsible for ensuring appropriate data correction in the safety database for identified issues or errors

•Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via communication module

oAccountable for training internal and external staff members on using communication module

oPerforms daily reconciliation of outgoing communications

•Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)

•Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners

•Supports PV Clinical Specialists in tasks and projects as needed

•Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)

•Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)

•Acts as single point of contact with key stakeholders for safety related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management

•Responsible for the preparation and development of Drug Safety presentations and participates in the education off or internal /external stakeholders as applicable

•Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs

•Provide support during audits and inspections

•Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

•Demonstrates capability to comprehend medical information

•Demonstrates ownership, initiative and accountability

•Sound decision making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility

•Demonstrates strong, dynamic leadership skills

•Works well independent or within teams and is effective in collaborating with others internally and externally

•Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g. evaluate, interpret and present highly complex data

•Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points

•Ability to flex and thrive in an agile and fast changing environment

•Strong attention-to-detail

Education, Experience, and Other Requirements:

•Health Care Professional degree (Required)

•Minimum 0-2 years of clinical experience (Required)

•Writing experience; science/medical writing (Required)

•Computer proficiency (Required)

•Data entry experience (Preferred)

•Able to travel as per business needs

We are looking for a talented Hematologist  / Oncologist to join our Rare Blood Blood Disease team as a Medical Director (Senior Medical Director).

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Medical Director participates in development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Medical Directors may have one or more direct reports. PD Medical Directors are expected to perform their responsibilities with more independence by comparison to Associate PD Medical Directors, including participating in health authority (HA) interactions with little to no supervision from their managers.

1. Cross-Functional Team Membership

• Participates in the relevant Clinical Science Team (CST)

• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

• As requested, supports the CST lead and overall team with training new CST members

• May also, as appropriate, support relevant sub-teams in training new team members

2. Global Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.

• Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)

• Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input

• Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs:

• Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients

3. Clinical Development Plan Implementation

• Provides clinical support across all relevant studies and programs

• Participates in ongoing CST and relevant sub-team meetings, Development Working Group (DWG), other interactions and communications

• Designs and develops clinical studies for review and discussion with other CST members

• Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials

• Participates in investigator and other external presentations, meetings and other communications

• Acts as a medical monitor for assigned studies

• Conducts ongoing reviews of medical/safety data

• Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such

• Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting

• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials

• Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science

• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

QUALIFICATIONS & EXPERIENCE

We are looking for a professional M.D. with relevant medical training in hematology / oncology required (M.D/PhD a plus) and 2 or more years (6 or more years for senior MD) pharma/biotech industry experience OR is a recognized expert in the field. You will bring:

• 2 or more years (6 or more years for senior MD) experience with clinical trials across Phase II – III drug development

• Academic/teaching background is a plus

• Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

• Experience developing product and safety profiles

• Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred (relevant for Senior MD)

• Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

ABILITIES:

• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values

• Outstanding attention-to-detail

• Has working knowledge of the multi-disciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.

• Good interpersonal, verbal communication and influencing skills; can influence without authority

• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

• Clinical leadership: is regarded as an expert in his/her field, is highly respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results (for senior MD)

• Ability to travel globally (<30%)

Roche is an equal opportunity employer.

The department of Structural Biology at Genentech has an exciting opportunity for a Senior Scientist with a strong background in protein biochemistry and structural biology.  This Senior Scientist will be responsible for the production of high-quality protein reagents to support small molecule drug discovery, antibody discovery, high-throughput screening, and DNA-encoded library technologies.  In addition, this Senior Scientist will employ a range of experimental methods (protein engineering, biochemical, biophysical and/or computational) to support structure-based drug design through high-resolution structural analyses.  Accordingly, proficiency in X-ray crystallography and/or cryo-EM methods is strongly desired, however we will also consider candidates who lack high-resolution protein structure determination experience so long as they have well-documented biochemical and/or biophysical assay experience, particularly as is relevant for the structural enablement of challenging protein targets.  

A passion to explore the structural basis of protein-ligand interactions is essential, as is a proven track-record of optimizing the expression and purification of challenging proteins for functional and structural studies.  Hands-on experience with different protein classes (i.e. soluble, membrane and/or secreted) is highly desired; experience in structural studies of G protein-coupled receptors (GPCRs) is a plus.    

The successful candidate will be a technical expert who can lead from the bench as well as through collaboration with colleagues on multiple projects, in parallel.  Overall, you will be an outstanding structural biologist and collaborator who will have a significant impact on our portfolio, with the unique opportunity to help drive discovery projects from inception to early development.

Who You Are:

Required qualifications: 

Ph.D. in biochemistry, biophysics, protein engineering, and/or structural biology with experience on multiple challenging protein targets.  Productive postdoctoral training and/or industry experience is expected and should be reflected in an established track-record of high impact publications.

Additional desired qualifications: 

• Hands-on experience engineering and optimizing the production of challenging protein targets for structural and/or functional studies

• Experience in structural studies of G protein-coupled receptors (GPCRs) is a plus

• Ability to generate and characterize milligram quantities of high-quality protein reagents

• Proficiency in structure determination using X-ray crystallography and/or cryo-EM is preferred

• Experience with protein engineering and/or design approaches

• Analysis, design, and/or computational approaches to investigate ligand-protein complexes

• Experience with selection technologies is a plus

• Excellent communication, interpersonal and organizational skills

• Team-oriented, collaborative nature with a fearless attitude to tackle long-standing important problems in drug discovery

#LI-NN1

Scientific Researcher, Translational Oncology In Vivo Pharmacology Group

In this position you will spend approximately 75% of the time supporting in vivo studies for primary investigators.  You will spend the remaining 25% of your time on general laboratory managerial duties such as stocking, assistance with lab equipment calibrations, maintaining lab/equipment cleanliness, and appropriately disposing of biohazardous and chemical waste. Training for assigned duties will be provided. These percentages may fluctuate depending on business needs.

• Administration of test compounds via PO, IP, SC, IV routes in a sterile lab environment
• Sample collections (blood collection via RO and tail vein/artery and the collection of various tissues),
• Basic animal care and husbandry tasks, and assisting with other animal related help requests.
• Animal monitoring, assisting with transplants or surgeries, performing procedures requiring anesthesia,
• Maintaining lab orderliness and compliance for inspections, preparing sterile packs, assisting to ensure lab equipment are calibrated and working with biohazardous and chemical materials.

Requirements:

In this position you will work a flexible work schedule.   Shift assignments are subject to change depending upon business needs.  Below are examples of a few possible work schedule scenarios:

• Working both weekend days and three weekdays (days off TBD) or
• One weekend day (Sat or Sun) and four weekdays (days off TBD)

In addition, you will need to be flexible with regard to start/end time, as shifts outside of regular business hours may be required due to business needs.  You will work 8 hours each workday regardless of start/end time (unless overtime or comp time is discussed in advance).  You will need to be available to work holidays on a rotational basis, and to provide work coverage for your team mates.

• AA degree + 4 years relevant biotech animal lab experience or
• Vet Tech + AALAS certifications (ALAT, LAT, LATG) + 2 years relevant biotech animal lab experience or
• BA/BS in Biology or other related field + 1 year of relevant biotech animal lab experience

Skills:

• Excellent skills in communication, organization, flexibility, and an eagerness to learn are essential.
• Must have a strong work ethic and be able to work independently or in a team setting.  
• Attention to detail and organization are critical attributes
• Must be dependable & honest, willing to follow procedural instructions. 
• Proficiency in basic rodent in vivo handling, dosing, and sample collection techniques.
• Computer proficiency, especially knowledge and use of emails, calendar, Google documents, Excel, and a basic knowledge of databases are necessary.
• Capable of standing, lifting, kneeling, bending, etc. for extended periods of time. 
• Willing to work with potentially hazardous materials and be able to lift a minimum of 50 pounds.
• Experience with in vivo oncology research a plus.

#LI-KS1

#Invivo, #Dosing, #Xenograft, #Oncology, #Vettech, #BioTech

Senior Business Manager, Development Sciences, Genentech Research & Early Development (gRED)

Job Description

The Business Management group’s vision is to provide the most efficient and strategic business solutions for Development Sciences (DevSci). 

The Senior Business Manager will contribute to the success of DevSci by leading/managing strategic planning activities and providing business management support to key scientific functions, managing essential cross-functional projects, as well as taking ongoing responsibility for certain key business processes.

The Business Management group ensures effective management of a wide range of projects and processes, for ~500 scientists and managers, in such areas as:

• Partnering with functional area heads (VP/Director-level) to enable them to meet functional goals and improve operational capabilities
• Being a thought-partner and advisor to DevSci leaders on business, organizational, and operational strategies and solutions
• Planning and implementing functional and cross-functional initiatives and deliverables
• Leading or managing DevSci initiative teams to ensure that deliverables are achieved timely and with a standard of excellence
• Identifying and potentially leading cross-functional business transformation and process improvement projects
• Owning and/or supporting various DevSci programs that contribute to Great Place to Work and innovation

The Senior Business Manager will be involved in multiple teams and support one or more functions simultaneously, as well as contributing as an individual on less complex efforts.

Successful factors for the Senior Business Manager include:

• Partnering with scientific functional leaders in driving business initiatives within the functions
• Balancing the needs of multiple competing priorities, with internal customers from several departments
• Providing project management expertise to cross-functional teams, including goal setting, planning, facilitation, conflict resolution and team building
• Independently managing and influencing multiple stakeholders simultaneously in a matrix organization
• Facilitating resolution of issues relating to projects, priorities and team dynamics
• Demonstrating creativity, independence, and initiative in resolving issues
• Understanding the strategic, big picture priorities while managing the detailed execution of deliverables

Qualifications

Minimum requirements:

• 5 years experience in applying and communicating project management principles and processes
• Prior experience working in a scientific/technical environment, preferably biotech
• Excellent communication skills, both written and oral
• Able to effectively partner with senior leaders in scientific/technical organizations
• Strong record of managing multiple stakeholders, and a desire to deliver service excellence
• High degree of flexibility, adapting to the organization’s priorities
• Strong analytical, critical thinking, and team facilitation skills to collaborate with key stakeholders.
• Ability to effectively function with limited direction
• Results oriented yet with a tolerance for ambiguity and change
• Able to prioritize team activities and influence strategy
• Advanced competence in use of software programs (MS Word, Excel and PowerPoint, Google Suite)
• Ability to work effectively on multiple projects simultaneously
• Minimum BS degree in scientific/technical field plus project management experience

Preferred:

• MS in a relevant scientific subject, and MBA
• 10+ years work experience, with 5+ years in biotech or pharmaceutical industry
• Prior role in consulting or client based environment
• Familiarity of informatics and data management
• Experience in a position where it was necessary to manage through influence
• Experience in working with scientific or highly technical clients
• Knowledge of and experience with change management practices
• Knowledge of Genentech or Roche culture, systems and organization

Summary:

The Senior Project Manager will report into the Research Contracts Group (RCG) organization within Research.  The Senior Project Manager will be the single point of contact for assigned Research departments for all agreement requirements and manage the full life-cycle of all such agreements. The Senior Project Manager will work closely with Research scientists, senior management, Legal, Finance as well as outside technology transfer offices and contracts teams, academic scientists and third party CROs.  The Senior Project Manager understands moderately to highly complex legal terminology, has broad experience drafting and negotiating contracts, including software and artificial intelligence (AI) related contracts and has knowledge of business matters in the pharmaceutical/biotech industry.

Responsibilities:

• Draft and negotiate software and AI related agreements, material transfer agreements, collaboration agreements, sponsored research agreements, license agreements, laboratory services agreements, confidential disclosure agreements and various other agreements, using department templates, playbooks and guidance documents, to meet the scientific and business needs of assigned departments in the Research organization.
• Applies functional and cross-functional expertise to independently draft and negotiate moderately to highly complex agreements, including routine and non-routine agreements for Research.
• Directly supports several Research departments, and acts as the single point of contact for internal and external stakeholders, for contractual matters for such departments. 
• Applies professional judgment to manage, complete and resolve problems of moderate to high complexity.
• May be required to maintain authorized forms and templates in RCG Project Management’s Database.
• Ensure that agreements comply with all applicable Research, Genentech, and Roche policies and procedures.
• Ensure that payment and other obligations under executed agreements are handled appropriately; work with Vendor Finance and Procurement to submit license and other fees for processing in a timely manner.
• Produce applicable data and statistical reporting (including budget reporting) for contracts to assigned Research departments.
• Create and implement new processes and efficiencies, as needed, for the Research Contracts Group.
• Provide recommendations and risk assessment on contracts and business terms to assigned departments.
• Present and share relevant issues to team members, stakeholders and scientists as needed, in addition to occasionally creating the content included in such presentations. 
• General alliance management responsibilities are required, including:
  • Reviewing fully executed agreements to determine effective/expirations dates, identifying and tracking reporting or other contractual obligations under such agreements;
  • Handle execution and post-execution processing of agreements, milestone payments including recording agreements in database, filing agreements with Records, and compiling tax forms and invoices for vendor finance. 
  • Data entry in the relevant databases.

Requirements:

• Bachelor’s degree in a scientific, business, or legal discipline.
• Minimum 6 years contracts experience in a software, tech, pharmaceutical/biotech and/or university setting, or
• Minimum 3 years contract experience in a software, tech, pharmaceutical/biotech and/or university setting with a JD.
• Ability to work independently as a self-starter, influence stakeholders through effective communication and handle multiple priorities in a fast-paced, high-pressure environment.
• Must leverage critical thinking skills to be able to independently and creatively solve problems.
• Must be able to effectively communicate with scientists, attorneys, contract negotiators, and industry executives.
• Strong understanding of legal issues, including but not limited to, intellectual property, indemnity, and confidentiality issues.
• Strong presentation skills
• General understanding of data protection laws is a plus.
• Strong time management, prioritization and organizational skills.
• Strong attention to detail, team player attitude, high work ethic and reliability.
• Demonstrated experience working with databases and enterprise business systems.
• Proficient with standard office suites such as Microsoft Office (Word, Excel, Powerpoint, etc.),  gSuite Applications (Mail, Calendar, Documents, Hangouts, etc.), and SLACK.

Preferences:

• BA, BS, MBA, or JD degree in a scientific, business, or legal discipline.
• Work experience in a pharmaceutical, biotech and/or university setting.
• Familiarity with software and artificial intelligence related agreements.

Physical Demands/Safety Considerations:

• Lifting up to 15lbs may be required
• Standard work requires a significant amount of keying and mousing.  Must be able to accommodate extended periods of computer usage to meet business needs.
• Ability to stand or sit for at least 6 hours each day.
• Ability to read and respond to at least 40 emails a day.

#LI-JD1

Job Scope:

As an individual contributor, the Bioanalytical Manager (BAM) provides bioanalytical operational expertise to local and global clinical trial teams, implementing and executing bioanalytical strategies in all phases of Genentech’s extensive clinical drug development pipeline. Serves as a single point of contact between scientific functions (Bioanalytical Sciences, Clinical Pharmacology, Drug Metabolism and Pharmacokinetics), Bioanalytical labs, and clinical trial teams. Ensures the timely and efficient delivery of all bioanalytical operational aspects for clinical trials in accordance with applicable quality and regulatory standards (e.g. ICH/GCP). 

Primary Responsibilities:

Works with bioanalytical scientific functions and with pharmacology sub-teams to provide input on PK/ADA deliverable timing, outsourcing budget estimate for bioanalysis, and to understand clinical program development direction (filings, new studies) to ensure program needs are met.

Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs (both bioanalytical CROs and Central Labs). Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual. Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle. Authors and reviews relevant sections of study related documents (i.e., central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.).

Develops study-specific sample and data flows plans with stakeholders, manages timelines for bioanalytical labs, and ensures samples are tested according to protocol and data is transferred in the specified format per study team timelines.

Assists function with outside spend budget planning and management of actual spend (invoices, PO) for studies.

Contributes to identification of bioanalysis CROs and set up of contracts for bioanalysis, working with internal contacts. Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide inputs on CRO performance, escalating concerns as appropriate.

May assist with training and participate on organizational initiatives to support business needs. Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).

Education and Experience Requirements:

Bachelor’s degree or higher in biology, chemistry, or related scientific discipline. Project management certification desirable.

8-11 years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.

Working knowledge of ICH GCP.

Skills:

Highly effective verbal and written communication.

Ability to make sound decisions with limited information in a changing landscape, influence, and negotiate effectively, using appropriate judgement.

Highly motivated and proactive in performing work independently with a problem-solving mindset.

Demonstrated evidence of successful collaboration and delivery of results in a highly matrixed organization, working with culturally and geographically diverse teams.

Excellent organization and project management skills with high attention to detail to independently manage multiple projects with competing priorities.

This is a local hire only designated position, as relocation assistance is not available for the position

#DevSci

#LI-HB2

Please note there are multiple positions. Positions will likely be Swing Shift (Wednesday through Saturday)

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.  We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.

The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion.  We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire.  Our Pharma vision is to have a greater overall patient benefit and impact.  This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life.  We hope you consider joining our team and being a part of one of the largest biotechnology facilities in the world! 

The Senior QC Analyst in QC Microbiology is responsible for sampling, testing, and release of utility systems and process spaces (cleanrooms) in Vacaville.

Responsibilities

• Perform routine and non-routine sample collection according to cGMPs

• Perform a broad variety of basic and moderately complex tasks in support of lab operations

• Perform assay/laboratory maintenance functions

• Prepare basic and complex laboratory reagents

• Order and maintain lab supply inventory

• Perform equipment qualification and maintenance

• Perform data verification and review

• Identify assay anomalies

• Initiate/assess discrepancies

• Anticipate problems and notify supervisor

• Understand theory of assays; use SOPs, validation protocols, specifications, trends, and expertise to propose solutions to assay issues

• Identify problems and propose solutions to systems, procedures, and training materials

• Understanding/knowledge of QC Microbiology systems

• Coaching of others in assay/laboratory functioning using higher level of technical expertise

• Assume responsibility for training and communication of issues

• Good understanding of global systems and GMP Compliance requirements/regulations

• Assist in preparing for internal and external inspections by ensuring Laboratory is inspection ready at all times

• Coordinate with customers to support operational activities

• Any other duties as assigned by management

Qualifications

• B.S./B.A degree in a scientific discipline, or an AA degree with 5+ years of related experience, or High School Diploma and 7+ years of related experience, or an equivalent combination of education and experience.  Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry

• Environmental monitoring, water collection, compressed gas testing for viable, non-viable, moisture and oil attributes, as well as Bioburden, Endotoxin, Conductivity, TOC, and/or Non Condensable Gas Testing of water/steam systems experience is a plus 

• Experience with facilities and utilities systems

• Experience with classified cleanroom gowning

• Strong verbal and written communication skills, ability to organize and present information both formally and informally

• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures

• Routinely exercises sound judgment, reasoning, and problem solving

• Capable of working under moderate supervision, independently and as a team, and determining own short-term priorities

• Capable of completing assigned responsibilities efficiently and keeping supervisor informed

• Ability to create an environment of strong team spirit with timely and effective communications

• Develop ability to influence using technical and personal reasoning

Work Environment/Physical Demands/Safety Considerations

• Capable of lifting up to 30 pounds. on flat ground and up stairs

• Able to work in process space areas requiring cleanroom gowning, including mask 

• Able to work in a laboratory environment in the presence of hazardous materials

• Laboratory work requires use of PPE, glassware, needles, syringes, hot water baths, and hot plates

• Able to make repetitive motions and manual manipulations

• Able to use stairs, bend, stoop, kneel as required for sampling and gowning procedures

• Must pass required visual acuity and color discrimination screening

• Must be able to work Day Shift or Swing Shift and weekends

#LI-AD1

#PTCareers

Perform adventitious agent testing in support of manufacturing operations, lot release and validation in accordance to standard operating procedures.  Collect, process, and report data.  Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.  Conduct routine and non-routine analysis of manufactured products.  Calibrate and maintain laboratory and instrumentation equipment.  Revise and update standard operation procedures. Develop and/or optimize testing methods and troubleshoot testing methods.  Maintain laboratories in audit ready and cGMP compliant manner.  Compile data for documentation of test procedures and prepare reports for internal and regulatory submissions.  Review and evaluate data for conformance to specifications/reports. Investigate anomalous data.  Use state-of-the-art techniques to evaluate and implement new techniques and technologies.  Maintain validation program for QC laboratory analytical instruments.  Evaluate and trend data and discrepancies.  Provide ongoing training and process improvements. Support product operations with special projects.

Job Responsibilities

Essential

• Collect, process and report on data for samples associated with in-process testing from the clinical and/or commercial manufacturing facilities
• Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information
• Apply advanced techniques to troubleshoot assay and equipment problems
• Perform adventitious agent testing at all levels of complexity to support manufactured products, investigations, special studies, and validations
• Train others in basic to complex laboratory and troubleshooting techniques
• Serve as a liaison for daily activities and special projects within QC or cross-functionally
• Act as subject matter expert for assays/areas of technical expertise and provide support to analysts within department and cross-site
• Perform data review, data trending, report writing, and lab maintenance
• Evaluate and implement new techniques and technologies
• Participate in routine projects
• Responsible for working independently as well as within a team 
• Responsible for collecting, entering data and generating reports from electronic systems
• Manage QC user administration requests for laboratory systems
• Perform day-to-day administration tasks using laboratory systems
• Identify and train in other applications or assays as necessary to support QC activities as a subject matter expert
• Identify functional improvement needs for laboratory systems or technical equipment
• Lead projects requiring technical or project management guidance
• Apply theories and principles from technical and/or professional discipline to independently address a variety of problems of moderate scope.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Act as designee in cross-site and/or interdepartmental meetings
• Facilitate team meetings as required
• Attends department and corporate meetings
• Attends seminars and/or classes to enhance technical or professional skills

Job Requirements

Education and Experience

• Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline
• 5-6 years of related experience 

Knowledge, Skills, and Abilities

• Demonstrate excellent organizational skills
• Strong written and verbal communication skills, with demonstrated leadership in a large group
• Computer skills- LIMS, Microsoft Word, Excel, Power Point, Visio
• Ability to read and follow Standard Operating Procedures
• Work under general supervision and guidance
• Ability to read and interpret technical data
• Ability to work in a fast pace environment with high volume testing schedules
• Experience in chemical and microbiological testing assays  
• Excellent aseptic technique
• Experience with electronic systems used in laboratories
• Detail-oriented
• Knowledge of laboratory safety procedures
• Experience working in GMP environment
• Experience speaking to auditors

Work Environment/Physical Demands/Safety Considerations

• Work in office and laboratory environment
• Lift up to 30lbs
• May work in the clean room environment that requires gowning and no make up or jewelry
• May work in the clean room environment where it is loud due to different equipment operating
• Work with some hazardous materials and chemicals
• Ability to sit, stand and move within work space for extended periods
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.
• Ability to stand 8 to 10 hours a day.

#LI-CA1

#ptcareers

In US Medical Affairs (USMA), we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USMA has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the dynamic health ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all.

Position Overview:

The Senior Therapeutic Area Lead in Medical Information is focused on developing the strategy and implementation plan as well as executing on content creation for multiple channels in a specific therapeutic area to assure scientifically accurate, impactful communications to patients, HCPs, and access stakeholders. Key responsibilities include planning, execution, creation, and review of scientific content for customer engagement, responding to medical and access inquiries, and strategic application of customer insights. You assure that the medical content provided via established and digital Medical Information channels as well as via the medical and commercial field interactions is strategically impactful, timely, accurate, and in a customer-focused format by:

• Planning, developing, and advancing the functional as well as influencing the cross-functional scientific communication strategies in support of the medical priorities of the Medical Network and the Squad in the assigned molecule/product/therapeutic area

• Acting as a Medical Information clinical expert of the assigned molecule/product/therapeutic area to internal and external customers, and as a medical communications expert in crafting medical content that is compliant and resonates with patients, HCPs, and access stakeholders; consistently approaching interactions with clinical integrity and the highest professional ethics in accordance with guidelines, direction, and key strategies

• Anticipating, identifying, articulating, and solving concerns on clinical, access, and operational issues (e.g., PI, PRC/RDC/MRT, pathways, guidelines, systems, processes) that impact Medical Information, Medical Affairs, and customers; and contributing to the development of new principles and concepts in solving these unusually complex problems

• Informing the development of Lifecycle/Medical Plans and medical initiatives to fill customer knowledge gaps through the strategic use of Medical Information/Medical Affairs insights

• Anticipating and applying an expert understanding of the medical information needs of worldwide customers and providing strategic responses to complex medical information requests with a highly developed knowledge of all customer types

• Independently leading departmental, cross-functional, and interdisciplinary team meetings and projects involved with complex issues, and contributing to inter- and intra-departmental business decisions

• Ensuring our partners have an understanding of the issue and the potential business impact of the key trends, themes or other evolutions in the external legal and regulatory landscape that relate to the work of Medical Information in the relevant therapeutic area(s)

• Identifying, influencing, and regularly checking in with external department leaders to understand their needs and perspectives as well as strengthen relationships to effectively move initiatives forward

• Ensuring assigned goals and objectives are met and that assigned work is completed on time, to high standards and within budget; also, providing guidance and managing work activities of others to accomplish goals and objectives

Core Accountabilities:

Depending on the resource model for the assigned therapeutic area, you may perform or oversee the following activities:

 

Strategy/Planning:

• Drive communication and content plans to be strategically aligned with medical priorities, deliver impactful results, and push innovation in cross-functional teams solving for complex issues that impact patients, HCPs, and access stakeholders

• Partner with stakeholders across USMA, Genentech, and Roche to break down silos to achieve results for the medical priorities

• Lead the medical information launch plan and strategy for the assigned molecule(s) or line extension(s) by working collaboratively and efficiently with all internal team members, partners and stakeholders to meet the anticipated and known medical information needs of patients, HCPs, and access stakeholders

• Inform the development of medical plan strategies and tactics through the strategic use of Medical Information/Medical Affairs insights for assigned molecules/products

• Proactively research, analyze and communicate key trends, themes or other evolutions in the external legal, regulatory, and access landscape that relate to the work of Medical Information in the relevant therapeutic area(s); innovate, develop, and contribute to updating and implementing departmental policies, procedures, and guidelines based on this knowledge

• Work with medical science liaisons (MSLs), medical executive directors (MEDs), medical science directors/medical directors (MSDs/MDs), medical partners, and Publication Planning to develop, disseminate and manage the timelines for scientific content communications and other relevant research and data communications for assigned molecules/products

• Maintain an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer, and healthcare/market landscape

Medical Writing and Communication/Evidence Submission:

• Create and co-create medical content for patients, providers, and payers to ensure scientific rigor, balance, and impact; this includes but is not limited to medical responses, Field Medical Affairs slides (MSLs and MEDs), emerging digital assets, evidence submissions (compendia, pathways, guidelines, and payer policies), and reprint dissemination materials.

• Provide medical review and input on the development/use of scientific and promotional materials and handle review processes (PRC, RDC) in close partnership with Medical Partners

• May act as the chair of the Reprint Dissemination Committee for the assigned product(s) or therapeutic area

• Write, maintain, review, and edit global medical responses to meet the medical information needs of worldwide and local customers

• Perform ongoing literature surveillance across multiple sources; critically evaluate data from multiple sources to deliver on the objectives of Medical Information activities

• Identify and address training needs of MI staff, internal partners, or external vendors, including USMA Contact Center. Write, review, edit and deliver medical content for training purposes

• Provide clinical guidance and medical information to assist the resolution of escalated medical and access inquiries from the USMA contact center

• Conduct quality assurance of vendor calls to ensure clinical accuracy, legal, regulatory and general compliance with Genentech/Roche standards, policies, procedures and protocols

• Measure the impact of medical information, and communicate these findings to key partners to strengthen collaboration and trust

QUALIFICATIONS & EXPERIENCES:

• Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD, etc.)

• 5 or more years’ relevant industry work experience or is a recognized expert in the field

• 5 or more years’ medical communication experience

• 2 or more years’ clinical experience or equivalent experience

• Significant experience with all aspects of healthcare communications activities

• Experience in a role that provided deep insight into fostering customer engagement through content creation

• Demonstrated experience with strategic planning, prioritizing and management of high-level initiatives and projects

• Superb collaboration and communication (oral and written) skills in developing strong partnerships with cross-functional peers

• Proven track record of collaborating, coaching and influencing outcomes in complex organizations and cross-functional projects

• Proven track record of meeting or exceeding objectives and goals

• Shows a proactive drive to negotiate, influence, coach and advise teams and leaders to develop valuable solutions

• Embraces an agile mindset to create necessary processes to get things done. Embraces a growth mindset to adapt and iterate in order to meet customer needs. Knows how to organize people and activities effectively to achieve impactful outcomes

• Substantive understanding and exposure to corporate legal and compliance groups, and is knowledgeable of issues related to, GCP, OIG, US Regulatory/FDA requirements, drug access and other guiding or controlling elements of our business

• Complies with all laws, regulations, policies, and procedures that govern the conduct of GNE principles

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive.

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.

Roche is an equal opportunity employer.

In US Medical Affairs (USMA), we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USMA has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the dynamic health ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all.

Position Overview:

The Product Lead in Medical Information – Solid Tumor is focused on developing the implementation plan as well as executing on content creation for multiple channels in a specific therapeutic area to assure scientifically accurate, impactful communications to patients, HCPs, and/or access stakeholders. Key responsibilities include planning, execution, creation, and review of scientific content for customer engagement, responding to medical and/or access inquiries, and strategic application of customer insights. You assure that the medical content provided via established and digital Medical Information channels as well as via the medical and commercial field interactions is strategically impactful, timely, accurate, and in a customer-focused format by:

• Planning, developing, and advancing the functional as well as influencing the cross-functional scientific communication strategies in support of the medical priorities of the Medical Network and the Squad in the assigned molecule/product area

• Acting as a Medical Information clinical expert of the assigned molecule/product area to internal and external customers, and as a medical communications expert in crafting medical content that is compliant and resonates with patients, HCPs, and/or access stakeholders; consistently approaching interactions with clinical integrity and the highest professional ethics in accordance with guidelines, direction, and key strategies

• Anticipating, identifying, articulating, and solving concerns on clinical, access, and operational issues (e.g., PI, PRC/RDC/MRT, pathways, guidelines, systems, processes) that impact Medical Information, Medical Affairs, and customers; and contributing to the development of new principles and concepts in solving these unusually complex problems

• Informing the development of Lifecycle/Medical Plans and medical initiatives to fill customer knowledge gaps through the strategic use of Medical Information/Medical Affairs insights

• Anticipating and applying an expert understanding of the medical information needs of worldwide customers and providing strategic responses to complex medical information requests with a highly developed knowledge of all customer types

• Independently leading departmental, cross-functional, and interdisciplinary team meetings and projects involved with complex issues, and contributing to inter- and intra-departmental business decisions

• Ensuring our partners have an understanding of the issue and the potential business impact of the key trends, themes or other evolutions in the external legal and regulatory landscape that relate to the work of Medical Information in the relevant therapeutic area(s)

• Identifying, influencing, and regularly checking in with external department leaders to understand their needs and perspectives as well as strengthen relationships to effectively move initiatives forward

• Ensuring assigned goals and objectives are met and that assigned work is completed on time, to high standards and within budget

Core Accountabilities:

Depending on the resource model for the assigned therapeutic area, you may perform or oversee the following activities:

 

Strategy/Planning:

• Drive communication and content plans of the assigned molecule/product to be strategically aligned with medical priorities, deliver impactful results, and push innovation in cross-functional teams solving for complex issues that impact patients, HCPs, and/or access stakeholders

• Partner with stakeholders across USMA, Genentech, and Roche to break down silos to achieve results for the medical priorities

• Lead the medical information launch plan and strategy for the assigned molecule or line extension by working collaboratively and efficiently with all internal team members, partners and stakeholders to meet the anticipated and known medical information needs of patients, HCPs, and/or access stakeholders

• Inform the development of medical plan strategies and tactics through the strategic use of Medical Information/Medical Affairs insights for assigned molecules/products

• Proactively research, analyze and communicate key trends, themes or other evolutions in the external legal, regulatory, and access landscape that relate to the work of Medical Information in the relevant therapeutic area(s); innovate, develop, and contribute to updating and implementing departmental policies, procedures, and guidelines based on this knowledge

• Work with medical science liaisons (MSLs), medical executive directors (MEDs), medical science directors/medical directors (MSDs/MDs), medical partners, and Publication Planning to develop, disseminate and manage the timelines for scientific content communications and other relevant research and data communications for assigned molecule/product

• Maintain an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer, and healthcare/market landscape

Medical Writing and Communication/Evidence Submission:

• Create and co-create medical content for patients, providers, and payers to ensure scientific rigor, balance, and impact; this includes but is not limited to medical responses, Field Medical Affairs slides (MSLs and MEDs), emerging digital assets, evidence submissions (compendia, pathways, guidelines, and payer policies), and reprint dissemination materials.

• Provide medical review and input on the development/use of scientific and promotional materials and handle review processes (PRC, RDC) in close partnership with Medical Partners

• May act as the chair of the Reprint Dissemination Committee for the assigned product(s) or therapeutic area

• Write, maintain, review, and edit global medical responses to meet the medical information needs of worldwide and local customers

• Perform ongoing literature surveillance across multiple sources; critically evaluate data from multiple sources to deliver on the objectives of Medical Information activities

• Identify and address training needs of MI staff, internal partners, or external vendors, including USMA Contact Center. Write, review, edit and deliver medical content for training purposes

• Provide clinical guidance and medical information to assist the resolution of escalated medical and/or access inquiries from the USMA contact center

• Conduct quality assurance of vendor calls to ensure clinical accuracy, legal, regulatory and general compliance with Genentech/Roche standards, policies, procedures and protocols

• Measure the impact of medical information, and communicate these findings to key partners to strengthen collaboration and trust

QUALIFICATIONS & EXPERIENCES:

• Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD, etc.)

• 5 or more years’ relevant industry work experience or is a recognized expert in the field

• 5 or more years’ medical communication experience

• 2 or more years’ clinical experience or equivalent experience

• Significant experience with all aspects of healthcare communications activities

• Experience in a role that provided deep insight into fostering customer engagement through content creation

• Demonstrated experience with strategic planning, prioritizing and management of high-level initiatives and projects

• Superb collaboration and communication (oral and written) skills in developing strong partnerships with cross-functional peers

• Proven track record of collaborating, coaching and influencing outcomes in complex organizations and cross-functional projects

• Proven track record of meeting or exceeding objectives and goals

• Shows a proactive drive to negotiate, influence, coach and advise teams and leaders to develop valuable solutions

• Embraces an agile mindset to create necessary processes to get things done. Embraces a growth mindset to adapt and iterate in order to meet customer needs. Knows how to organize activities effectively to achieve impactful outcomes

• Substantive understanding and exposure to corporate legal and compliance groups, and is knowledgeable of issues related to, GCP, OIG, US Regulatory/FDA requirements, drug access and other guiding or controlling elements of our business

• Complies with all laws, regulations, policies, and procedures that govern the conduct of GNE principles

CMG Operating Principles

I put the patient first, always

I am obsessed with meeting customer needs

I act on behalf of the whole company, not just my team

I am inclusive

I have a growth mindset

I act with urgency

I am accountable

I radically simplify and prioritize for impact

I follow the science

I build our reputation

External Link: https://www.gene.com/careers/commercial-operating-principles

 REQUIREMENTS:

@               Must possess knowledge of the fundamental operating principles of industrial process instrumentation and process control systems.

@               Respond and resolve instrument problem troubleshooting and repairs of all the HTO site control systems including Filling, Packaging, Inspection, QC, Tank Management, Utilities, Warehouse and Distribution Center.

• Able to use working knowledge and thorough understanding of the site's control systems to recognize and effectively communicate all repair issues to management.

@I             Must possess the ability to create, read, interpret and revise engineering documents.

e       Must possess documentation and attention to detail skills to ensure work orders, GMP

compliance, safety and other regulatory documents are readable and error free.

• Ability to read and Understand P&IDs, work from Standard Operating Procedures (SOPs) and have computer skills using word processors, spreadsheets, databases, and email.

•     Ability to perform maintenance and instrument calibrations according to Standard Operating Procedures and Work Instructions.

• Able to adjust all the site's instruments and repair instrument malfunctions.  

•     Proficiency in understanding of Federal, State, Local and Genentech regulations, procedures, and policies.

PREFERENCES:

•     Demonstrate writing skills including preparing technical reports, creation of new complex documents, the revision of various technical documentation and procedures.

•     Demonstrates a strong ability to collaborate with and become a resource to customers. Anticipates, identifies and defines needs. Demonstrated ability to take ownership of customer's problem.

•     Effectively work under general supervision. Manager provides work priorities, timelines and resources.

•     Ability to lift up to 50 pounds.

•     Ability to work overtime or temporarily modify shift schedule to support manufacturing operations

as needed.

TRAINING DUTIES:

•     Attend all required cGMP training as required by Department Policy

•     Attend all required Safety training as required by Department Policy

•     Complete on-the-job training Using established training procedures

EDUCATION / TRAINING:

Completion of an approved 2-year instrumentation or industrial Engineering curriculum at a technical school, or an AAIAS Degree in a related science or engineering major.

•     Thorough knowledge of the fundamental operating principles of industrial process instrumentation systems.

•     Strong interpersonal skills are a must.

•     Proficiency  in both oral and written communications is essential.

Summary:

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in one functional area. Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities:

Essential

• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Troubleshoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.

• A good working knowledge of biopharm technology and processes. 
• Trained and skilled in all operational procedures of at least one manufacturing department.
• Demonstrated ability to independently document and record information related to the process.
• Occasionally makes routine decisions based on experience.  Identifies and suggests solutions to common basic problems.
• Recognizes non-routine problems, investigates and suggests potential solutions.
• Judgment is required in resolving problems and making routine recommendations. 
• Ability to recognize deviation from accepted practices is required.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities:

• Operate bioreactors, centrifuges, other harvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20-L batch feed bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Perform Solution Preparation activities (media and buffer make-up).
• Clean, assemble, and sterilize equipment using glass washers and autoclaves.
• Perform automated CIP and SIP of fixed equipment.

Summary:

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in one functional area. Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities:

Essential

• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Troubleshoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.

• A good working knowledge of biopharm technology and processes. 
• Trained and skilled in all operational procedures of at least one manufacturing department.
• Demonstrated ability to independently document and record information related to the process.
• Occasionally makes routine decisions based on experience.  Identifies and suggests solutions to common basic problems.
• Recognizes non-routine problems, investigates and suggests potential solutions.
• Judgment is required in resolving problems and making routine recommendations. 
• Ability to recognize deviation from accepted practices is required.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities:

• Operate bioreactors, centrifuges, other harvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20-L batch feed bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Perform Solution Preparation activities (media and buffer make-up).
• Clean, assemble, and sterilize equipment using glass washers and autoclaves.
• Perform automated CIP and SIP of fixed equipment.

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in one functional area.  Understands and applies biological, chemical and mechanical principles and techniques.

Essential

• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
• A good working knowledge of biopharm technology and processes. 
• Trained and skilled in all operational procedures of at least one manufacturing department.
• Demonstrated ability to independently document and record information related to the process.
• Occasionally makes routine decisions based on experience.  Identifies and suggests solutions to common basic problems.
• Recognizes non-routine problems, investigates and suggests potential solutions.
• Judgment is required in resolving problems and making routine recommendations. 
• Ability to recognize deviation from accepted practices is required.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Perform Solution Preparation activities (media and buffer make-up).
• Clean, assemble, and sterilize equipment using glass washers and autoclaves.
• Perform automated CIP and SIP of fixed equipment.

Education and Experience

• Degree in Life Sciences or Engineering and 1 year related experience, or Associate degree and 3 years experience, or High school and 5 years experience.
• Biotech certificate from approved program.

Knowledge, Skills and Abilities

• Strong oral and written communication skills.
• Familiarity of computer-based systems.
• Background in fermentation.
• Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.

• Schedule could include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
• Expected to be on feet for 8 to 10 hours a day.
• May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
• Lifting up to 25lbs may be required.
• Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.  Also, no make up or jewelry can be worn when working in the clean room environment.
• May work with hazardous materials and chemicals.