Therapeutic Area Manager (TAM), SKIN – Virginia Ecosystem

Position Overview

From the beginning, 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.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, 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 and 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 as appropriate; focused 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.  The TAM will represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

There are two levels of Therapeutic Area Managers. The difference is based on the scope, complexity and criticality to the ecosystem business as well as differences in expertise required to execute responsibilities.

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 TA squad strategies at the point-of-care

Apply strong understanding of the specific needs of healthcare practitioners and mobilizes 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 HD and FRM as appropriate

Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities 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

• 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 
• Clinical nurse or Advanced Practice Nurse (APN) experience highly valued
• Ability to work in an ambiguous environment undergoing transformation is a strong plus
• Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such 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; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem 
• Ability to assimilate and communicate complex clinical and product information 
• Knowledge of and ability to successfully addressing operational issues in the delivery of healthcare products to patients, such as reimbursement and supply
• Understanding of external laws, codes and company policies that apply to the healthcare industry

E5 Distinctions:

• Deep understanding of the overall and unspecified abstract needs of healthcare practitioners (HCPs) to identify and surface their clinical and business goals and challenges
• Lead end to end experience for assigned customers/accounts and drive demand at the point of care
• Solve unusually complex problems using multiple dynamic sources of information
• Play coach/mentor role to other TAMs within the ecosystem
• 6 or more years experience working in a sales role with HCPs

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 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.

It is highly preferred the candidate live within the ecosystem. 

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal 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.

#LI-TW1

Major Responsibilities

Development Sciences Informatics is seeking a talented and experienced informatics engineer to develop scientific software tools, software engineering, bioinformatics algorithm design, pipeline development and implementation. You will provide engineering leadership in collaboration with scientists and other engineers to facilitate deep exploration of multidimensional preclinical and clinical omics data. You should have a flexible and learning mindset, be able to work in a fluid and dynamic environment, be comfortable leading globally distributed development teams and have a strong desire to pursue creative solutions to challenging problems.

• Design and develop scientific databases, create methods to process and analyze omics data or other biological information.
• Lead application development efforts and establish data engineering platforms to enable the storage, organization, dissemination, and analytics of dynamic data generated from innovative research, exploratory and clinical studies.
• Contribute to strategic planning and implementation of our data engineering platforms for multiple functions to ensure data accessibility, quality, and integrity.
• Lead local and off-shore engineering teams to delivery informatics solutions and meet business needs.

Major Responsibilities

Development Sciences Informatics is seeking a talented and experienced solution architecture to drive the application development efforts that assist in discovering groundbreaking therapeutics. You will lead the development of scientific databases and scalable data processing systems to support the data life cycle from planning to acquisition to processing, and release. You will provide engineering leadership in collaboration with scientists and other engineers to facilitate deep exploration of multidimensional preclinical and clinical omics data. You should have a flexible and learning mindset, be able to work in a fluid and dynamic environment, be comfortable leading globally distributed development teams and have a strong desire to pursue creative solutions to challenging problems.

• Establish and maintain the technical and scientific partnership with scientific functions. Communicate effectively with key stake holders.
• Contribute to strategic planning and implementation of our data engineering platforms for multiple functions to ensure data accessibility, quality, and integrity.
• Lead and perform application design, database modeling, and software development. Evaluate systems to accommodate ongoing data management needs. Participate and lead multiple projects.
• Maintain expertise and knowledge of technology trend and informatics landscape in our industry. Assess and identify new opportunities for data management and utilization to further drug discovery and development efforts.
• Lead local and off-shore engineering teams to delivery informatics solutions and meet business needs.

We are seeking a highly motivated and scientifically excellent Associate Director to join our Biochemical and Cellular Pharmacology group.  This position will collaborate with Directors in our all Therapeutic Areas, Protein Sciences and Chemistry to drive drug discovery projects for Genentech Research across small, large and novel drug modalities.  Our Biochemical and Cellular Pharmacology group designs and executes highly rigorous and quantitative in vitro enzyme and cell based assays to discover and evolve project molecules from the earliest screening efforts at project inception to the final IND candidate.  We work closely with our disease area scientists to ensure our in vitro functional pharmacology assays faithfully recapitulate human disease.

In this role, you will lead a team of researchers in a fast-paced and highly collaborative environment to drive projects forward across the portfolio. You will continually adapt and evolve our innovative technology platforms to suit the next generation of targets and therapeutic modalities.  You will be a member of the Senior Leadership Team of Biochemical and Cellular Pharmacology and work directly with the Vice President to determine department strategy and decide on budget and resource deployment.  You and your team will work very closely with the biology groups focused on key therapeutic areas, as well as Antibody Engineering, Protein Chemistry, Early Discovery Biochemistry and Chemistry groups to drive transformational therapies into the clinic.

Who You Are

The successful candidate must be inspired to lead teams of people to deliver new medicines for patients. She/he must have a PhD in Molecular Biology, Biochemistry, Genetics, Biology, or a related discipline. A minimum of 10 years of excellent management skills with prior experience managing Scientists is required.   The candidate must have expertise in in vitro assay development and driving drug discovery programs. She/he must also be familiar with cutting-edge technology in the quantitative assay space and be able to partner with Business Development to identify the most strategic opportunities for Genentech. The successful candidate will have demonstrated success leading drug discovery teams in a collaborative manner. Expertise in deriving and maintaining complex in vitro disease models is a plus. The candidate must also be an excellent communicator and have a solution-oriented mindset toward both scientific problems and team dynamics.

The In Vivo Pharmacology group within the department of Translational Oncology has an opportunity for an experienced and highly motivated Scientific Supervisor/Manager.  The group focuses on the in vivo assessment of candidate drug targets and therapeutics across multiple programs ranging from early stage research and target validation to late stage clinical candidates.  The position requires an individual with strong experience in utilizing animal models of cancer, particularly genetically engineered mice, xenograft and allograft tumor models.  Experience with developing novel tumor models (e.g. genetically engineered models, inducible shRNA or target over-expressing models, organoids), development of orthotopic tumor models, metastatic tumor models, and/or with small animal imaging is highly desirable.  The candidate should have experience with running drug pharmacokinetics/pharmacodynamics (PK/PD) studies to examine biological mechanism of action in cell-based and tumor samples.  The candidate should also have working familiarity with commonly used laboratory skills (e.g. cell culture, Western blotting, ELISA, flow cytometry, etc.).  The Scientific Supervisor/Manager will also require strong organizational and personnel managerial skills to serve on demanding project teams and to oversee the work of multiple research associates.

Requirements:

• Applicants should have a PhD degree + 5 years or 10+ years of relevant experience in molecular biology, biochemistry, cell biology, pharmacology or related science, with an emphasis on the modeling of cancer in small animals.
• The position requires a minimum of 5-10 years of hands-on laboratory and vivarium experience, preferably in industry.
• The position requires a proven track record of accomplishment in the development and assessment of drug targets and/or candidates in animal models of cancer.
• Qualified candidates will have proven ability to design, execute and interpret experiments independently and will have publications in peer-reviewed journals.
• Strong oral and written communication skills, as well as excellent documentation and organizational skills are essential.
• The successful candidate should be highly self-motivated, and possess strong problem solving and interpersonal skills to facilitate cross-functional interactions and collaboration with others.
• Strong managerial skills are required, including the ability to organize multiple work streams, the ability to multi-task, and prior experience with managing direct reports.

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 

Key Accountabilities

• Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
• Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
• Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
• Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
• Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
• Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

• Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
• Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
• Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
• As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
• Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
• Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
• In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
• Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
• In conjunction with the region’s field team:
  • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
  • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
  • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
  • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
• Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
• Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
• Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
• Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
• Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
• This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
• Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
• This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

• Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
• 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
• Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
• Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
• Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
• Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
• Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech’s 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. 

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

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal 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.

#LICOMMCG2

As a Manufacturing Technician, you will be responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in a current Good Manufacturing Practices (cGMP) environment. You will maintain areas in a high state of inspection preparedness and will utilize business systems for inventory and process management. You will maintain records to comply with regulatory requirements utilizing cGMP and Standard Operating Procedures (SOPs) and will participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

• Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.
• Downstream Manufacturing (DM): ​Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials.
• Production Services (PS):Provide support to Manufacturing to meet production demands. Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; provide quality materials and service to our customers.

Additionally, you will be accountable to:

● Follow established safety and environmental guidelines and procedures for all work performed

● Immediately report safety and environmental incidents, including injuries, illnesses, near misses, and safety suggestions

● Foster safe work practices

● Operate systems that clean and sterilize tanks and filtration systems

● Prepare materials for the production process

● Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)

● Escalate process issues as necessary to ensure resolution of issue

● Comply with cGMP, SOP and manufacturing documentation

● Use automation to perform production and equipment operations

● Provide support to Manufacturing to meet production demands

● Assemble and prepare equipment for production

● Communicate effectively and professionally work in a team environment

Education and Experience

  Required: High School Diploma

●  Desirable but not required: AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering or combination of college coursework and related work experience or Biotech certificate from approved program

Knowledge, Skills, and Abilities

● Strong oral and written communication skills

● Familiarity of computer-based systems

● Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job

● Ability to read and understand engineering documents is desirable

● Experience in creation and revision of SOPs and Manufacturing Formula is desirable

● Must be able to work weekends, off-shifts, and overtime as required

● No make-up or jewelry can be worn when working in the clean room environment

● Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems

● Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift

● Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift

● Handle and work with hazardous materials and chemicals per OSHA guidelines

● Usage of hearing protection and dust masks may be required

● Expected to be on feet standing or walking for up to 90% of shift

● Travel up to 30 flights of stairs each shift to maneuver within the facility

● Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems

● Lift up to 40lb(18.2kg) loads multiple times per shift and carry up to 30 lbs(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.

● Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.

● Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).

● In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’s License

Please note: This job posting is a sourcing requisition. All applications received on this job posting will be reviewed by the onsite Talent Partner in Vacaville and candidates will be considered for both full-time regular AND contingent worker (temporary assignment) positions.

Work Shifts: Our manufacturing production facility operates 24/7. You must be able to work all of the shifts listed below. At the time of hire, you will assigned to a specific shift.

• Front Swing Sun-Wed 16:00-2:30
• Front Swing Mon-Fri 6:00-14:30
• Back Swing Thu-Sat 13:30-2:30
• Front Swing Sun-Wed 16:00-2:30
• Back Swing Thu-Sat 6:00-19:00
• Front Days Sun-Wed 6:00-16:30
• Back Days Thu-Sat 6:00-16:30

The Position:

The Genentech Personalized Healthcare Informatics seeks a talented and motivated clinical imaging data management engineer. Your responsibilities will include working with a diverse team of scientists and Informatics staff to curate, organize, and document clinical images from Genentech and Roche trials. You will also support development of advanced analytics algorithms utilizing these clinical images to address scientific questions related to prognostic and/or predictive biomarkers. The job will utilize and build on your experience in scientific/medical imaging, image and data management, and algorithm development.

Responsibilities:

• Work with scientists, contractors, and IT staff to curate, organize, and document clinical images from Genentech and Roche trials 

• Support data integration efforts across diverse data sources

• Support development of Machine Learning/Deep Learning (ML/DL) algorithms and pipelines using the image data

• Continually search for opportunities to automate workflows and streamline processes

• Work directly with outside vendors and in-house staff to reconcile and resolve data transfer issues

• Report on imaging assets to business stakeholders

• Coordinate transfers of clinical imaging data from outside sources using a variety of data transfer options such as sFTP, Box.com, Aspera, etc.

• Promote and educate customers and stakeholders on the Clinical Imaging platform functionality to ensure successful adoption

• Work with business stakeholders and customers to identify functional needs for Clinical Imaging platform and ensure delivery working with product team

Required skills:

• Bachelor’s degree in Computer Science, Biomedical Engineering, or a similar discipline; Master of Science preferred

• 7+ years experience working in Clinical Imaging and/or Data and Analytics and a demonstrated ability to work in fast-paced, high-growth environment

• Experience with clinical imaging in multiple therapeutic areas such as Oncology, Ophthalmology and Neurology

• Experience with medical/clinical image data analysis techniques

• Proficient in scripting languages such as Python, Matlab, etc.

• Some experience with database applications

• Experience with medical image formats (e.g., DICOM, nifti) is required

• Experience with ML/DL a plus

• Understanding of clinical trials a plus

• Excellent communication and presentation skills

Experience Profile:

• Experience and understanding of application development methodology - including Agile and Waterfall approaches, functional requirements, process modeling and re-engineering, use case development, user acceptance testing, organizational change management, and large-scale system implementations.

• Excellent written and verbal communication skills; able to quickly produce clearly written, well-organized documentation; excellent presentation and meeting facilitation skills.

• Proven skills in relationship building, customer-focus, decision-making, and problem solving

• Demonstrated ability to quickly learn the business in unfamiliar areas

• Experience with and understanding of any of the following areas a plus:

  • Pharmaceutical/Biotech Good Clinical Practice (GCP) environment

  • Business processes around financial controls and portfolio management of large scale engineering capital projects

  • Computer systems validation

#LI-CM1

#ITcareers

• Participate and thrive in an interactive, purpose driven culture

Who you are

A leader with a strong scientific and clinical background who has a passion for making medical progress for people affected by MS. You are looking for a company where you have the opportunity to positively impact peoples’ health, and where a job title does not define who you are professionally but is the starting point of what you can achieve.

Qualifications, Experience and Skills

• Board Certified physician with clinical experience in Neurology/ MS is preferred

• Minimum 5-10  years of relevant clinical / medical pharmaceutical/biotechnology industry experience

• Experience or relevant knowledge of pre-approval drug development trials and/or post-marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations

• Understanding of the US health care environment including the payer landscape, evidence-based medicine tools and practices, and health technology assessments

• Ability to navigate complex and challenging situations and flex and thrive in an ambiguous environment. The position is located in South San Francisco but the candidate may be remote but would be required to spend time in the home office. The position may requires up to an additional 35% time traveling.

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

Roche is an equal opportunity employer.

• Profiling and identifying/elucidating drug metabolites in in vitro and in vivo biological matrices (e.g., hepatocytes, blood) using high resolution LC-MS/MS and metabolite identification software
• Developing and implementing appropriate assays (e.g., Met ID, reactivity) and strategies to support design and optimization of small molecules (non-covalent and covalent binders) and other modalities (e.g., peptides, degraders, oligonucleotides)
• Identifying soft spots, major metabolic pathways, responsible metabolizing enzymes and structure-metabolism relationships
• Working with medicinal chemists to influence drug design with biotransformation insights
• Working with CROs on assay development and data QC
• Evaluating new technologies and software

• PhD degree in chemistry, biochemistry, pharmaceutical sciences or other related disciplines.
• Good understanding of metabolic enzyme reaction mechanisms, enzyme kinetics and clearance mechanism in support of drug discovery programs
• Experience with MS-based structural elucidation of unknown small molecule and peptide structures, high resolution LC-MS/MS instrumentation and data analysis, method development and trouble-shooting
• Proven abilities in determining the biotransformation pathways of small molecules, peptides and/or other modalities
• Proven track record of scientific achievements and communication skills

• Participate and thrive in an interactive, purpose driven culture

Who you are

A leader with a strong scientific and clinical background who has a passion for making medical progress for people affected by MS. You are looking for a company where you have the opportunity to positively impact peoples’ health, and where a job title does not define who you are professionally but is the starting point of what you can achieve.

Qualifications, Experience and Skills

• Board Certified physician with clinical experience in Neurology/ MS is preferred

• Minimum 5-10  years of relevant clinical / medical pharmaceutical/biotechnology industry experience

• Experience or relevant knowledge of pre-approval drug development trials and/or post-marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations

• Understanding of the US health care environment including the payer landscape, evidence-based medicine tools and practices, and health technology assessments

• Ability to navigate complex and challenging situations and flex and thrive in an ambiguous environment. The position is located in South San Francisco but the candidate may be remote but would be required to spend time in the home office. The position may requires up to an additional 35% time traveling.

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

Roche is an equal opportunity employer.

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 

Key Accountabilities

• Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
• Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
• Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
• Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
• Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
• Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

• Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
• Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
• Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
• As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
• Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
• Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
• In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
• Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
• In conjunction with the region’s field team:
  • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
  • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
  • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
  • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
• Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
• Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
• Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
• Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
• Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
• This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
• Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
• This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

• Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
• 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
• Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
• Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
• Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
• Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
• Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech’s 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. 

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

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal 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.

#LICOMMCG2

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 

Key Accountabilities

• Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
• Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
• Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
• Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
• Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
• Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

• Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
• Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
• Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
• As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
• Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
• Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
• In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
• Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
• In conjunction with the region’s field team:
  • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
  • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
  • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
  • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
• Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
• Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
• Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
• Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
• Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
• This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
• Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
• This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

• Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
• 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
• Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
• Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
• Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
• Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
• Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech’s 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. 

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

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal 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.

#LICOMMCG2

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 

Key Accountabilities

• Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
• Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
• Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
• Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
• Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
• Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

• Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
• Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
• Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
• As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
• Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
• Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
• In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
• Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
• In conjunction with the region’s field team:
  • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
  • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
  • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
  • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
• Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
• Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
• Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
• Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
• Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
• This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
• Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
• This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

• Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
• 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
• Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
• Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
• Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
• Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
• Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech’s 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. 

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

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal 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.

#LICOMMCG2

Summary

As a manufacturing technician you will be responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment while maintaining areas in a high state of inspection preparedness. Follows standard operating procedures to operate production equipment for cell culture or purification. Maintains records, process 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: Productions Services (PS), Upstream/Downstream Manufacturing. Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities

Comply with safety requirements, cGMP, SOP and manufacturing documentation.

Immediately report safety and environmental incidents, including injuries, illness, near miss & safety suggestions.

Utilize automated systems to operate, clean and sterilize production equipment.

• 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.
• Operate fermenters, centrifuges, other harvest systems and protein purification units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Prepare solutions required for the production process (media and buffer make-up).
• Clean, assemble, and sterilize equipment for production by operating glass washers and autoclaves.

Trained and skilled in all operational procedures of at least one manufacturing department.

Exhibit detail-oriented documentation and check all data entries (e.g. tickets, labels, equipment reading).

Demonstrated ability to independently document and record information related to the process.

Good judgement is required to recognize non-routine problems/deviations, escalate and partner on potential solutions.

Receive, interpret and provide basic information for systems and materials involved with the day to day activities of performing the job.



Work Environment/Physical Demands/Safety Considerations:

Schedule could include a rotating (12 hour shift), one weekend day, evening, night, or full off-shift hours.

Expected to be on feet for 8 to 11 hours a day.

May climb multiple flights of stairs a day to maneuver within the manufacturing facility.

Ability to lift up to 25lbs may be required.

Environment requires daily gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots to be worn. 

Usage of hearing protection and dust masks may be required.

No make-up or jewelry can be worn when working in the clean room environment.

May work with hazardous materials and chemicals.

(Determine if DOT physical info should be included)

Skills

Foster a safe and collaborative work environment.

Strong oral and written communication and the ability to collaborate with a team.

Exhibit professional interpersonal skills.

A good working knowledge of biopharma technology and processes. 

Education

REQUIRED: High school diploma

PREFERRED: Degree in Life Sciences/Engineering, Associate degree or Biotech certificate from approved program.

Genentech’s South San Francisco manufacturing facility has an opportunity available in the Process Engineering group supporting cGMP manufacturing of both clinical and commercial products. The group is responsible for monitoring, troubleshooting, and improving upstream and downstream unit operations from seed train through bulk formulation, and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.  

Responsibilities of this position include:

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Provide manufacturing floor technical support
• Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
• Analyze data and execute experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment
• Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Support of regulatory inspections and filings
• Create / revise standard operating procedures and manufacturing tickets
• Provide training and technical mentorship for manufacturing operators
• Lead cross-functional technical teams on large scale improvement and compliance related initiatives

We are seeking applicants who possess the following minimum qualifications. The position can be filled as an Engineer or Manufacturing Technical Specialist (MTS). The job family and level of the position will depend on the qualifications of the selected candidate.

• Bachelor’s degree in Engineering, Science, or related discipline
• 2+ years of relevant experience in industry or academia (including advanced studies); candidates with more extensive experience may be considered for a senior level.
• Experience working in a cGMP environment
• Experience with cell culture and/or purification process science/development strongly preferred
• Knowledge of safety principles, quality systems, and cGMP
• Knowledge of large scale biopharmaceutical manufacturing processes and equipment
• Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
• Highly motivated and proactive with a track record of taking initiative to achieve business results
• Demonstrated strong problem solving capabilities
• Able to work independently and as part of a team
• Strong oral and written communication skills
• Excellent organization skills

Job Description

ROLE / JOB TITLE: Business Analyst, Virtual Engagement Strategy

FUNCTION: US Medical Affairs (USMA)

REPORTS TO: Director, Virtual Engagement Strategy

LOCATION: South San Francisco

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 Business Analyst on the Virtual Engagement Strategy team in Medical Information supports the development and implementation of digital and systems strategy for Medical Information to enable consistent, personalized, and impactful communications to customers (patients, caregivers, healthcare providers, payers, and policymakers) that enhance their experience, support improved patient outcomes, and foster an ongoing connection with Genentech. This individual also provides cross-therapeutic scientific expertise for standard or more complex literature searches, literature surveillance excellence, and copyright management expertise as needed. This individual reports to the Director of Virtual Engagement Strategy. 

• Drive the design of digital channels and systems in alignment with the digital and systems strategy for Medical Information, and implement the plan in collaboration with key internal stakeholders
• Anticipate, identify, articulate, and solve concerns on operational issues that impact Medical Information, Medical Affairs, and customers as well as global/corporate issues that require multidisciplinary and strategic resolution skills
• Contribute to the ongoing evolution of systems architecture to ensure an end-to-end system that can support future customer strategies and foster new methodologies and innovations 
• Provide scientific literature research consultation and support for Medical Information activities and drive the management of literature research operations to enable best-in-class literature search practices meeting critical medical information needs of MI customers
• Support the design and operations of integrating the use of medical analytics and insights to strategically and efficiently drive the delivery of impactful content
• Proactively research, analyze and communicate key trends, themes or other evolutions in the library sciences, digital communications, or artificial intelligence landscape that relate to the work of Medical Information; innovate, develop, and contribute to updating and implementing departmental or corporate policies, procedures, and guidelines based on this knowledge

Core Accountabilities:

Systems Design and Implementation

• Design and shape assigned channels for customer-centric systems and digital engagement by bringing the customer voice and needs into the room
• Closely partner with in-person and virtual customer engagement stakeholders across CMG to ensure coordination and flow of information across systems (e.g., FMT, Medical Networks, Squads, Ecosystems, DCx, and IT)
• Analyze/document current and future business process models, high-level requirements (scope), and detailed functional specifications and/or stories; communicate to the lead developers and extended team effectively
• Create virtual engagement efficiencies by leveraging synergies and connecting platforms (systems and digital) across USMA, CMG, and Roche to streamline approach, improve efficiencies and reduce duplications
• Gather insights and latest trends from an assigned segment of the landscape to identify emerging healthcare, digital, and technology trends for digital opportunities and innovations for Medical Information
• Implement measures of digital effectiveness to the overall customer engagement strategy, such as utilization, accessibility, frequency of use/visits, customer enablement and impact
• Develop and update the Standard Operating Procedures, protocols, and processes for virtual engagement (digital and systems) for Medical Information
• Perform knowledge transfer to training and communication teams and support user deployment activities as needed

Literature Research Expertise

• Provide primary biomedical, clinical and pharmaceutical information expertise and oversight for both standard and more complex scientific literature research
• Facilitate strategic literature research management/operations initiatives in USMA, including working with other business partners across Genentech/Roche
• Act as the lead subject matter expert (SME) and internal consultant to others regarding biomedical literature and copyright
• Work independently with USMA leadership and staff, Informatics (IT) and other internal partners/stakeholders to implement a scalable literature and copyright business support model that provides USMA with long-term benefits
• Develop and update the Standard Operating Procedures, protocols, and processes for literature research management and operations

QUALIFICATIONS & EXPERIENCES:

• 5 or more years of experience in shaping and managing virtual customer-centric communication channels in a complex and highly regulated industry environment, ideally in positions related to Healthcare Communications in the pharmaceutical / biotechnology industry and Medical Affairs
• 5 or more years of experience as a Business Analyst
• 5 or more years of experience with a wide range of scientific information resources and systems
• Experience with all aspects of Healthcare Communications activities, and other Medical Affairs activities and healthcare professional and patient/patient groups interactions strongly preferred
• Experience in a role that provided deep insight into fostering customer engagement through virtual and digital channels
• Superb collaboration and communication (oral and written) skills in developing strong partnerships with cross-functional peers
• Proven track record of collaborating, influencing outcomes, and achieving results in complex organizations and cross-functional projects
• Shows a proactive drive to negotiate, influence, 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.
• Good understanding and exposure to corporate legal and compliance groups, and be knowledgeable of issues related to, GCP, OIG, US Regulatory/FDA requirements, and other guiding or controlling elements of our business
• Complies with all laws, regulations, policies, and procedures that govern the conduct of GNE principles
• Bachelor’s degree required (PharmD, PhD preferred)

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

We are seeking a high-energy individual who enjoys working in a fast-paced science environment. This position will provide direct high-level administrative support to the Department of Cellular and Tissue Genomics and the Department of Artificial Intelligence and Machine Learning. In this role, you will contribute to organizational and administrative goals to ensure the smooth daily operation of the supported departments including coordination of meetings on site and off site, travel, and visits by external seminar speakers and interviewing candidates. You will also closely interface with other administrative staff in the gRED Research organization.

Duties and Expectations:

• Acts as the departmental "go-to-person" for general operational or administrative questions

• Streamline and improve inefficient administrative workflows operational burdens

• Assists in various administrative or operational activities such as coordinating, scheduling, preparing briefing materials, and preparing for meetings or presentations, gathering information and/or conducting analyses needed for the department's work, formatting or editing departmental materials, presentations or other documentation, channeling communication between the department and other Genentech groups, etc.

• Train new team members on company and departmental administrative and general processes, systems, practices, tools and standards

• Responsible for maintaining updated departmental rosters, organization charts, e-mail distribution lists, complete with all employee and other key departmental information

• Coordinate recruiting activities including travel and interview scheduling

• Coordinate and manages any office moves and/or office conversions

• Where assigned, coordinates departmental or other team meetings and may directly manage or facilitate all event planning and management activities

• Coordinate and schedule travel, accommodation and pay for external speakers

Job Requirements

• A minimum of a BS/BA degree, an AA degree and 4 years of administrative experience or transferable administrative skills, or a High School Diploma and 7 years of administrative experience or transferable administrative skills. Support of project teams and biotech industry experiences is a plus.

• Strong computer skills utilizing MS Word, PowerPoint, Excel, Google Apps (Gmail, Docs, Sites, Drive, Calendar, Sheets, Forms, Slides, Hangouts), WebEx; experience with Sharepoint or similar document management system, task management apps (e.g. Asana), Adobe Suites.

• Excellent communication skills and the ability to interact professionally with all levels of staff and with external contacts in a fast-paced environment.

• Works independently under general supervision and is self-motivated. Has outstanding organizational skills, including the ability to manage several tasks concurrently. Able to anticipate impact on other areas and to address problems by developing practical, thorough, and creative solutions without necessarily relying on supervisory review.

• Must be able to prioritize, problem-solve, and work independently, practice strong organizational skills and attention to detail.

• Must exercise judgment and discretion regarding sensitive/confidential and proprietary information.

• Participate, plan, coordinate and prioritize work within and across departments by providing project leadership, direction, training, and assistance to others.

• Understand and troubleshoot from a broad perspective and anticipate the impact of office administration problems and solutions on other areas.

• Able to handle routine and impromptu assignments with minimal or no supervision.

#LI-GL1

Note:

• This role may be filled at the Associate Project Coordinator or Project Coordinator level.

• We are only considering San Francisco Bay Area candidates.  No relocation support is available for this role.

RESPONSIBILITIES: 

This is a hybrid project coordinator and lab analyst position. The position will coordinate Process Validation (PV) study samples, documentation and results and join the assay scheduling team in Analytical Operations (AO). It will also support analytical testing by executing and documenting methods per test procedure returning quality data and participating in lab maintenance.

Process Validation in Analytical Operations (PVAO) is a part of AO in Pharma Technical Development (PTD). AO provides analytical support for process development enabling informed and timely process decisions. AO develops and runs a wide variety of technologies including lab automation, ELISAs, UHPLC and mass spectrometry supporting PTD from Stage A through D and E.

PVAO coordinates analytical testing in support of PV studies, technology transfers, and investigations for Stage D and post-approval molecules across the Roche network. Project Coordinators manage sample coordination, data and documentation in a compliant environment tracking metrics and maintaining business systems.

Specific job duties/responsibilities include: handling of biological and chemical reagents, following study protocols, preparing samples, scheduling testing, communicating study status to stakeholders, overseeing the quality and compliance of the work, executing assays per test procedure, assay and lab maintenance, presenting in formal settings, and writing summary reports.

The individual will be required to work independently as well as in a team environment within AO and with analytical groups, technical teams, quality, BioProcess groups, and external contacts for contract manufacturing facilities or satellite Genentech facilities. They will communicate effectively with all levels of the organization. The individual will be expected to follow applicable procedures, quality standards and policies, and comply with industry guidelines.

REQUIREMENTS:

Bachelor's degree in Biological Sciences field with a minimum of 1-2 years of laboratory experience in biotechnology area. Requires initiative, attention to detail and a desire to deliver high quality work.  Must be able to manage multiple projects simultaneously and accommodate shifting priorities and timelines. Must be willing to support analytical testing and project coordination.

Additional requirements include: strong written and verbal communication, good organization, multi-tasking and problem-solving skills, familiarity and knowledge of cGMP’s and compliance. Knowledge of analytical methodologies (ELISAs, UHPLC, or others) is also desirable.

Proficiency in Microsoft Word and Excel is necessary. Experience with Electronic Lab Notebooks (ELN), LIMS, databases and programming, experience running analytical assays such as ELISA and HPLC, and project management experience are pluses.

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PRODUCT STRATEGY LEADER

With patients’ health and well-being depending on the reliable supply of high-quality medicines, effective Product Lifecycle Management of Roche’s portfolio of therapeutic products is crucial. Our organization, Technical Product Management and Network Strategy (TPM), is responsible for delivery of end-to-end product and network strategy to ensure faster supply to more patients. Our leaders sit between development, manufacturing, supply chain and commercial global functions and markets providing a unique view to the full industrialization and commercialization of our portfolio. Through leadership and partnerships, we ensure execution of Roche enterprise supply strategy by developing and managing a portfolio and network view.

We are looking for a Product Strategy Leader (PSL) to join our team. In this role you will be accountable for commercial launch and technical lifecycle management of assigned product(s). You will own the end-to-end product strategy and execution focusing on the largest value driving stages of the product life cycle, from commercial launch through the resilient stage, and preparing the product to be fully established. As a leader in this organization you will be the Pharma Global Technical Operations (PT) “Voice of the Product” translating the business drivers for the product and external trends and insights into robust supply chain lifecycle plans that enable patient access and product value. 

In addition, your responsibilities will be:

• Design the end-to-end supply chains for the full product lifecycle, translating business strategy and lifecycle vision into the PT plan for execution. 
• Set “Best in Class” supply chain performance targets across the product lifecycle, ensuring long term execution is on track to deliver the commercial ambition for the product (e.g. cost, format focused on customer need, access for patient reach). 
• Drive decisions from a whole system and portfolio perspective to make best use of resources and drive the highest value. Understand and articulate key drivers, interdependencies, and implications emerging from strategic decisions.
• Create Product Books to align the organization with the lifecycle strategy. Translate external insights, competitive landscape and commercial objectives into agreed financial, operational and project objectives that optimize product performance. 
• Effectively manage holistic end-to-end strategic risk through the product lifecycle, ensuring robustness and resiliency by proactively addressing supply, product or compliance risks
• Actively support the Long Range Planning (LRP) probabilistic forecasting, ensuring an enterprise strategy that considers product and network implications.
• Develop scenarios and prepare options for the supply chain to respond to upside and downside of commercial forecasts.
• Lead and manage global matrixed Technical Product Teams (TPTs) for PT, including members across the following functions: Development, Supply Chain, Quality, Technical Regulatory, Finance & Manufacturing.
• Represent PT voice on the Product Lifecycle teams, driving teamwork between TPTs, PT, GPS and Pharma
• Embrace and employ Lean Production System and Agile methodologies including lean leadership, continuous improvement, rapid experimentation, and iteration. 
• Enable teams to shape product strategy through engagement of customers and stakeholders. Approach problems and co-create solutions across PT and GPS
• Inspire and lead others to communicate and act with a clear vision and purpose, connecting different perspectives; Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.

In order to be successful in this position, you should have:

• BS / MS Degree (life sciences, engineering and/or business disciplines preferred)
• 10 years of multi-disciplinary work experience in the Pharma / Biotech industry. 15+ years preferred. 
• Knowledge of various manufacturing processes and platforms, and the relevant GMP quality and regulatory dependencies 
• Business Acumen and Problem-solving skills that you are able to apply within a supply chain context
• 7 or more years’ previous senior people management or senior matrix team leadership experience. 10+ years preferred.
• Deep understanding of the pharmaceutical commercial markets and process development
• Ability to effectively handle ambiguity and uncertainty
• Proven ability to build trustful and effective relationships
• Able to think strategically and translate strategies into actionable plans
• Strong verbal and written communication skills and the ability to influence at all levels
• International / global experience is strongly preferred.
• Able to travel globally

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