Job Search

Start date: Summer 2019

Length: 10-12 weeks

This is an opportunity within the Site Services Organization: Facilities Operations Maintenance (FOM). FOM provides reliable, cost-effective operation and maintenance to buildings, facilities, laboratories, utilities and equipment. FOM is fully committed to quality and dedicated to continuous improvement through innovation and providing technical leadership in developing solutions to meet the needs of a growing campus in support of Commercial, Clinical Product Manufacturing and R&D operations.

FOM - South Campus Operations Intern

• Implementation of projects with a focus on equipment and utility system improvements. I.e. Reduce repair lead for Lab hoods, Alarm Reconciliation (clearing nuisance alarms)
• Creation/revision of documents in collaboration with other functional groups.
• Adherence to all applicable compliance and safety requirements, cGMPs, SOPs, and other laboratory or manufacturing documents.
• Ability to fully utilize (Microsoft Office Suite, eMail, Google Docs)).
• Summarizing projects, highlighting the accomplishments in a poster/oral presentation at staff/department meetings.
• Participate fully in the Genentech Intern Poster, Illustration day and Intern Video presentation.

FOM - South Campus Project Intern

• Improving existing tools to benefit Operations Group: a)Work with Building Automation System team to scope and execute improvements for the existing BAS. b) Work with internal CAD department, Reliability Engineering, FOM experts to improve facility drawings to ease access to up-to-date information.
• Develop trouble-shooting guides for maintenance of equipment: a) Work with third party maintenance vendor, Reliability Engineering, and Equipment Manager to develop format and structure for trouble shooting guides on existing equipment.
• Adherence to all applicable compliance and safety requirements, cGMPs, SOPs, and other laboratory or manufacturing documents.
• Ability to fully utilize (Microsoft Office Suite, gMail, Google Docs)).
• Implementation of projects with a focus on equipment and utility system improvements.
• Creation/revision of documents in collaboration with other functional groups.
• Summarizing projects, highlighting the accomplishments in a poster/oral presentation at staff/department meetings.
• Participate fully in the Genentech Intern Poster, Illustration day and Intern Video presentation.

Neurology Rare Disease Specialist - Richmond/Virginia Beach

Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

Genentech has numerous molecules in Phase I, II and III clinical trials in neuroscience disease areas including but not limited to Spinal Muscular Atrophy (SMA), Huntington’s Disease (HD), Alzheimer's and Autism.  Additional information on Genentech’s neuroscience pipeline can be found here - https://www.gene.com/medical-professionals/pipeline

Rare Diseases are common in neurology and due to the prevalence of neurological symptoms in rare diseases- of the estimated 7,000 known rare diseases that lead to significant morbidity and mortality in 25 million people in the United States, a third are thought to include a neurological component.

People with neurological rare diseases often wait for a long time for a correct diagnosis and treatment.  Although a limited number of orphan drugs are approved for neurological conditions, many orphan drugs are in development.  People living with a neurological rare disease and their caregivers are highly engaged in their treatment and with their communities via local advocacy chapters where they often attend meetings and events along with the HCPs. Our marketing team is working closely with our legal and compliance partners to ensure we are prepared to support our customers while engaging compliantly and consistent with our values. As we embark on this journey, we are seeking to build strong, customer-focused teams who will represent Genentech with integrity.

The Neurology Rare Disease Specialist manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, they will represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the clinical information of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Interested candidates should demonstrate the following:

• You have significant customer field experience in the pharmaceutical / biotechnology industry and have the entrepreneurial spirit and to help build our U.S. business and team.

• You have represented specialty drugs before, have product launch experience and may have specific neuroscience, rare disease and/or orphan drug experience.

• You regularly demonstrate your integrity, entrepreneurialism, nimbleness, flexibility and team spirit.

• You enjoy working in a team environment and collaborating with other business partners in the field who also support your customers.

• As an experienced field professional, you have consistently met or exceeded performance expectations and other critical business goals and metrics in a highly complex and competitive market.

• You understand payer and reimbursement landscape, and will support customers to remove access burdens for appropriate patients to receive treatment

• You have experience working with practice managers, societies and other reimbursement entities

Example Duties and Responsibilities:

• Shares on label clinical information with appropriate HCPs

• Partners effectively with Patient Assistance Liaison (PAL) to ensure positive end to end HCP, Patient, Caregiver experience

• Responsible for meeting or exceeding assigned performance goals

• Partners with PAL to effectively develop robust local geography business plans in collaboration with internal partners, as needed.

• Develops strong and long-term relationships with customers in all assigned accounts

• Participates in the development and execution of compliant, customer oriented local geography reimbursement strategies and goals to support HCPs and patients

• Works closely with PAL and Case Manager roles to proactively identify trends.

• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands

• Monitors operating costs and compliance with territory budget

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

• This role will be compensated on base salary and MBOs field IC

• Business travel, by air or car, is regularly required

Key Competency Profile:

• Technical & Business Expertise

• Inspiring & Influencing

• Achieving Results

• Decision Making

• Teamwork & Collaboration

Qualifications and Experience: unless stated as “preferred” or “a plus,” all other criteria is required

• Bachelors Degree

• 5 or more years’ customer field experience in the pharmaceutical / biotechnology industry preferred

• New product launch and reimbursement experience is strongly preferred

• Outstanding interpersonal,  presentation, influencing and negotiation skills; you have highly developed consultative selling skills and help your customers find solutions to their needs or problems

• Neuroscience, rare disease and/or orphan experience preferred

• Proven track record of meeting or exceeding objectives & goals

• Previous experience in achieving specific brand performance plans or other financial targets is preferred

NOTE:

This is a remote position that requires significant use of either a company provided or personal vehicle to perform 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.

Success in this role will often require Specialists to attend events and meetings during evenings and weekends. This person is expected to prioritize these events and meetings in order to represent Genentech and support patients and caregivers in their communities. While work hours are typically not to exceed 40 hours per week, flexible schedules to accommodate evening and weekend work will be operationalized.

Patient Assistance Liaison - Los Angeles

Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

Genentech has numerous molecules in Phase I, II and III clinical trials in neuroscience disease areas including but not limited to Spinal Muscular Atrophy (SMA), Huntington’s Disease (HD), Alzheimer's and Autism.  Additional information on Genentech’s neuroscience pipeline can be found here - https://www.gene.com/medical-professionals/pipeline

Rare Diseases are common in neurology and due to the prevalence of neurological symptoms in rare diseases- of the estimated 7,000 known rare diseases that lead to significant morbidity and mortality in 25 million people in the United States, a third are thought to include a neurological component.

People with neurological rare diseases often wait for a long time for a correct diagnosis and treatment.  Although a limited number of orphan drugs are approved for neurological conditions, many orphan drugs are in development.  People living with a neurological rare disease and their caregivers are highly engaged in their treatment and with their communities via local advocacy chapters where they often attend meetings and events along with the HCPs. Our marketing team is working closely with our legal and compliance partners to ensure we are prepared to support our customers while engaging compliantly and consistent with our values. As we embark on this journey, we are seeking to build strong, customer-focused teams who will represent Genentech with integrity.

The Patient Assistance Liaison is a newly created position responsible for advocacy relations, educating patients and caregivers on the clinical profile, approved administration process, and compliantly supporting customers by minimizing patient specific access and reimbursement barriers for the continuity of care.  

The PAL works with Account Specialists and they are aligned to a shared team with shared goals, to ensure seamless geographic alignment across patients, caregivers, HCPs and advocacy to effectively address local territory needs.

PAL's provide clinical education, administration access (IT or Oral), and reimbursement expertise for patients, caregivers and HCPs when needed and builds trust in Genentech within local neurology communities prior to launch and availability of Risdiplam and RG6042 (pending FDA marketing clearance)

The PAL's compensation plan including base salary and a MBO-based quarterly bonus structure.

Front-line Customer Facing Activities

• Facilitates, staffs and attends local advocacy events; at local advocacy chapters to help create a positive, trusted, and lasting presence of Genentech in the neurology rare disease community; engages with local advocacy on programming and marketing-related sponsorships

• Provides information and educational in-services on Genentech and approved unbranded disease and, when applicable, product education to patients, caregivers and the community

• Provides clinical education to patients and works with HCP account specialist regarding in-services to HCP customers

• Provides on label patient education after the clinical decision has been made

• Communicates Payer terms, identifies and resolves on- label reimbursement issues or concerns, leverages in house support teams, as needed.

• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources

• Partners with HCP Account Specialist and may serve as a conduit between the healthcare provider and case managers to support patient access to therapy

• Assists with patient specific case management needs

• Local advocacy development – payer, office administrator, intrathecal sites and works with relevant state, institutional or other societies

• Complies with all laws, regulations and policies that govern the conduct of GNE activities and demonstrates a commitment to Genentech policies and the agile compliance philosophy

• Obtains and maintains full proficiency in disease state, product and business knowledge

• Attends and actively participates in team/region/franchise calls and meetings

• Meets administrative expectations consistently

• Communicates and aligns with field partners to determine educational opportunities and priorities

• Collaborates with home office and customer-facing representatives to align on local priorities and supports needs to achieve results and ensure effective execution

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

• Understands and adheres to HIPAA and all patient privacy policies

• Demonstrates high ethical and professional standards, and demonstrates Genentech values consistently with all customers and business

Key Competencies

The successful candidate will demonstrate the following competencies critical to this role:

• Inspiring and Influencing

• Communication

• Teamwork and Collaboration

• Achieving Results

• Technical and Business Expertise (nursing, clinical educator, relevant therapeutic area expertise; passion for patients, peers and education; customer focus)

Qualifications

• Bachelor’s Degree required

• Masters degree in Science, MBA or other related graduate-level degree is preferred

• 5 or more years work experience

• 5 or more years of clinical experience in Neurology, and/or infusion related products preferred.

• Direct to patient experience required

• A minimum of 2 or more years direct experience with managed care and reimbursement is preferred, either directly within/from the pharmaceutical/biotech industry or relevant, large-scale practice management

• Previous experience in Neurology therapeutic area(s) is strongly preferred

• Previous experience with both private & public payers is preferred

• Previous experience in other functions in the pharmaceutical/biotech industry is a plus, e.g. product marketing, managed care marketing, field sales/sales management, field account management, etc.

• Proven track record for consistently meeting or exceeding goals and objectives

• Previous work or clinical specific experience in the pharmaceutical, biotech, or related

• industry is preferred

• In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunizations, TB, hepatitis, and drug screening)

Success in this role will often require PALs to attend events and meetings during evenings and weekends.  This person is expected to prioritize these events and meetings in order to represent Genentech and support patients and caregivers in their communities.  While work hours are typically not to exceed 40 hours per week, flexible schedules to accommodate evening and weekend work will be operationalized.

Must live within the territory, preferably near a metropolitan area.

This position requires significant use of either a company provided or personal vehicle to perform 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 Description

Considering local candidates only ​

All qualified candidates are encouraged to apply and will be actively considered.  Our talent review and succession planning process has, however, pre-identified potential candidates for this position.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES: 

1.  Cross-Functional Team Leadership & People Management 

• Is a standing member of the Clinical Science Team or ad hoc member of relevant sub-teams and as such, may regularly present/lead discussion of clinical data updates to the CST
• Effectively represents Clinical Science (CS) on the Execution Teams of assigned molecule(s)/indication(s), and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CDP execution including regular review and analysis of protocol deviations, authoring of study start-up documents required from Clinical Science, and review of all study documents requiring clinical expertise as identified by the Execution Team(s)
• Contributes to clinical documentation of study execution including management of regulated documents and notes of clinical decisions and study conduct that are considered permanent record 
• Originates clarifications to protocols and the initial draft of protocol amendments, and ensures any protocol amendments and corresponding Informed Consent Forms are completed as meets study team needs
• Authors with guidance and in collaboration with Medical Writer any clinical sections of regulatory documents that support on-going or concluded clinical trials 
• Conducts medical data reviews, including collaborating with Data Management to ensure all queries submitted to sites by Clinical Science have been appropriately addressed
• Collaborates with the Visual Analytics Manager to tailor Spotfire’s clinical and safety data displays to assigned studies.
• Acts as a first point of contact for protocol-related inquiries from Genentech colleagues and external sites and addresses queries or triages as appropriate
• Collaborates with Safety Science to identify and track any potential safety events within a given trial
• Supports departmental goals and initiatives

2.  QUALIFICATIONS & EXPERIENCE: 

• Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.) 
• Generally, 0-2 years pharma/biotech industry experience or demonstrates relevant equivalent clinical or laboratory research experience
• Has experience working in complex matrixed setting(s)
• In-depth understanding of Phase I-II drug development
• Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance 
• Understanding of product and safety profiles 
• Well-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 
• Strong computer skills 

3. ABILITIES:

• Proven abilities to perform CS responsibilities with some supervision from more senior colleagues. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies
• Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, gRED values 
• Outstanding attention to detail 
• Developing business acumen; is aware of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results 
• Excellent project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance
• Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally 
• Outstanding written communication skills 
• Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points 
• Excellent teamwork skills: knows how to complete deliverables by working effectively with colleagues; can effectively drive discussions and decisions toward desired end-results 

Relocation is not designated for this position

Basic Function:

The MDIS Medical Data Hub (MDH) Technical Specialists are experts in databases (e.g. Teradata/Hadoop/Redshift), big data solutions, analytical tools and technologies used to facilitate the use of medical data by analysts. The MDH Technical Specialists partner with Development / Research analysts and scientists to curate, load, and transform medical data (e.g. Flatiron EMR and Marketscan claims data).  The MDH Technical Specialists develop tools, visualizations, and processes to facilitate access to medical data in the Medical Data Hub.

Role Responsibilities:

• Responsible for the lifecycle (loading -> destruction) of data available in the Medical Data Hub
• Works with vendors to resolve any data issues
• Executes global & functional efforts related to improving access and usage of medical data
• Actively contributes in PDB, MDIS and MDH forums  
• Maintains a strong partnership with partners inside and outside of PDB (e.g. PHC, Diagnostics, USMA, REDs)
• Implements new and innovative technologies as appropriate to business need
• Identifies opportunities to improve business processes, adheres to established business processes, and encourages consistent approaches to MDIS accountabilities
• Responsible for support of MDH users and delivering MDH training

Skills:

• Familiar with Big Data systems/platforms (e.g. Hadoop and/or Teradata).
• Strong knowledge of relational database principals and corresponding query language skills (e.g. SQL, NoSQL).
• Experience programming with R, SAS, Python and/or visualization tools (Tableau, Spotfire)
• Knowledge of drug development (pre-clinical, clinical development and post-marketing) and experience with international regulatory and ICH GCP guidelines.
• Experience with real world data, clinical trial data, molecular biomarker or genotype data
• Knowledge / experience with data standards (CDISC, OMOP)
• Excellent communication skills; ability to negotiate successfully; strong influencing skills.
• Strong problem-solving skills and attention to detail. Thinks quickly under pressure.
• Innovative thinker; open to new ideas; embraces and drives change.
• Awareness of changing trends in industry.

Background/Experience and Education:

• M.S. or advanced degree in Data Science related field (e.g. Statistics, Mathematics, Epidemiology, Health Economics, Outcomes Research, Computer Science)
• Experience as an analyst (e.g.  SAS, R, python, SQL) or with ETL processes & tools
• Experience working with medical data
• Good knowledge of English in a business environment

#LI-PDBA1

Genentech's department of Immunology Discovery is responsible for basic research, target discovery, and pre-clinical drug development for a broad range of autoimmune, inflammatory, fibrotic, and ophthalmic disorders. We are looking for a highly motivated researcher to build and lead a laboratory focusing on the interface between the immune system and the microbiome. The successful candidate will have the opportunity to take advantage of unprecedented sample and data collection from ongoing and planned clinical trials, and collaborate with colleagues in Infectious Disease, Translational Immunology, Biomarker Discovery, Human Genetics, and Bioinformatics groups.

Qualifications: PhD in immunology, microbiology, or related discipline, 3+ years of postdoctoral experience, demonstrated track record of scientific achievement as evidenced by first-author publications in high-impact journals. Candidates with experience researching commensal or pathogenic bacteria, fungi, or viruses and bioinformatic analysis of metagenomic data are favored.

The Clinical Pharmacology Scientist is responsible for the Clinical Pharmacology (CP) strategy for his/her development project[s] in order to ensure that appropriate dose/route/schedule decisions are made for the patients.  The CP Scientist uses state of the art model-informed drug development strategies that are aligned with project needs. The CP Scientist works in close partnership with Pharmacometricians, Biostatisticians, Clinicians and cross-functional project teams. Responsibilities include; leading the design & review of CP study protocols and analysis plans where appropriate, contributing to the design and review of clinical protocols and analysis plans, analysis and interpretation of PK/PD data, preparation and review of clinical study reports, presentation of PK/PD data at cross-functional teams, department meetings, conferences and regulatory meetings as well as planning, implementation and organization of regulatory filings (eg. IND, End-of Phase 2 meeting, EU Scientific Advice meeting, BLA, NDA, sNDA).

Technical Skills:

• Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (eg. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses.  Familiarity with clinical study design options, especially for phase 1 and 2 studies.  Working knowledge of statistical approaches as they apply to clinical study design & analysis.  Working knowledge of relevant disease areas.

Communication Skills:

• The CP Scientist requires excellent communication skills, both written and oral, in order to deliver high quality protocols, regulatory documents, documents for team and management review, scientific manuscripts & posters for publication.

Drug Development Knowledge:

• The CP Scientist requires relevant experience/knowledge of how CP science can impact drug development. CP Scientist should have  a good knowledge of GCP and working knowledge of relevant regulatory guidelines.

Leadership:

• Based on experience and ability, the CP Scientist may lead CP teams, project sub-teams and represent CP at cross-functional project teams.  Based on experience and ability, the CP Scientist may manage other Scientists or Research Associates within CP department.

Qualifications:

• MD, PhD, PharmD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.

#LI-GREDNN1

#ASCPT19

#devsci

Preferred location: global with a preference for SSF or Basel

Intro:

As Senior Category Manager, Professional Services Emerging Categories, you are part of the Professional Services Global Category and Supplier Management team within Roche Global Procurement, and you will be working on developing and executing Global Strategies around emerging categories (with an initial focus on digitalization (RPA) and outsourcing) as part of the Professional Services Category team.

Global Procurement (GP) is a key function that delivers value to Roche by leveraging market knowledge, subject matter expertise and business insights in the procurement of goods and services and the management of Roche’s third party spend. Through collaboration with our external suppliers and internal business partners, GP helps bring innovative tests and medicines to patients.

Description:

As the Senior Category Manager Emerging Categories, in collaboration with the other Category team members, you are responsible for identifying, testing and building up new category opportunities so that they can then be fully developed by the other Professional Services category teams into global category strategies. You are proactively identifying opportunities, engaging and partnering with senior Business stakeholders, as well as colleagues in Professional Services global and regional Procurement, and establishing relationships with emerging category suppliers to develop opportunities that contribute to the Professional Services Category objectives and savings targets.

You are a strategic visionary who is able to turn your ideas into deliverables and can operate comfortably in novel territory. Your agile, yet delivery-oriented, mindset helps you identify and prioritize emerging procurement trends and successfully deliver proofs of concept. Thanks to your strong leadership, communication and influencing skills, you secure alignment and support to deliver exceptional value through the implementation of innovative, emerging category projects.

Your responsibilities:

• Developing a pipeline of emerging category projects by following emerging procurement trends across industries and closely collaborating with the Professional Services Category Managers to identify new category needs within Roche. 
• Ensuring a robust approach to identifying and developing emerging categories in Professional Services and delivering to the identified measures of success (including % POC success rate and % of category initiatives developed category strategies).
• Engaging with existing and new suppliers to secure access for Roche to innovative solutions.
• Obtaining sponsorship for innovative category projects, developing and delivering rigorous proofs of concept and partnering with other Category Managers to transition initiatives for further category development and widescale adoption.
• Providing innovation and emerging category related input to the development of the overall Professional Services Strategy.
• Understanding business priorities and challenges and ensuring successful realization of emerging category initiatives by building strong partnerships across geographically dispersed stakeholders and engaging with Professional Services Category Managers and local and regional Procurement.
• Contributing to the Professional Services team’s culture, objectives and engagement as a member of the Professional Services Leadership Team (reporting into the Head of Professional Services).

Your qualification:

• University degree, with business, technology or life sciences degree preferable.
• 7+ years of in-depth strategic and/or operational procurement experience with extensive knowledge of category management and advanced strategic sourcing, ideally with subject matter expertise in technology.
• Experience working on an innovation team and/or developing and leading innovation programs.
• Experience in IT system design and deployment a plus.
• Excellent communication and project management skills with an ability to lead and coordinate cross-functional teams and deliver complex strategic initiatives, in a truly global, fluid, interactive environment.
• Proven financial and business acumen and capability in negotiation, change management and stakeholder management.
• Business level fluency in English.

Please note:  Day Shift- 4 days/week; 10 hours/day, 5:00 am – 3:30 pm, Monday - Thursday

Location:

Hillsboro, OR

4625 NW Brookwood Pkwy, Builiding 1



Duties:

• Support the Manufacturing department by working effectively to meet department goals, objectives and tasks to achieve desired results.
• Responsible for completing assigned tasks which include cleaning, sterilizing, and prepping glassware and parts used in the manufacturing environment.
• Work with senior technicians and leads to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on shift needs.
• May also include stocking, inventory and environmental monitoring.

Skills:

• Must possess good problem solving, interpersonal communication, and team skills and have experience and knowledge in a GMP environment.
• Must be a self-starter with strong focus on quality, details, results and application of cGMP.
• Must be able to work weekends and off shift.

Education: 

• High school diploma or equivalent

Bachelor's Degree in Life Sciences or Engineering or equivalent education with work experience is a plus

 

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). 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.

• Technician (N2)

• Follow 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 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.

• Senior Technician (N3) – All N2 responsibilities, plus…

• Be able to perform all routine operations
• Train other technicians in group and individual settings
• Troubleshoot process equipment and systems

• Master Technician (N4) – All N3 responsibilities, plus…

• Serve as an example and advocate of ingrained quality
• Champion safety improvements and encourages safe work practices in department
• Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools
• Contribute to the improvement of training material and practices
• Serve as department representative on cross-functional teams
• Demonstrate Roche Leadership Competencies within Department and to the site
• Be able to act as SME to regulatory agencies
• Lead troubleshooting efforts to resolve complex process issues

Education and Experience

• 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 Standard Operating Procedures and Manufacturing Formula is desirable.

• Must be able 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

The Role

The IT Business Partner for Site Services will be reporting to Workplace and Employee Experience Team Lead and be responsible for shaping up the new workplace technology at Genentech through information and technology partnering. The Workplace and Employee Experience Team is responsible to support Corporate Functions (Legal, HR, Site Services, Corp Relations etc.) at Genentech, deliver End User Technology (Devices, Software Deployment etc.) and provide a frictionless employee experience via technology.

The Product Manager / Senior Product Manager in Systems and Process Excellence (SPE) is a strategic thought partner to key stakeholders and an integral contributor to Genentech’s operational planning efforts to proactively evolve for the overall good of Clinical Operations.  

The role of Product Manager / Sr. Product Manager represents the business and acts as the product manager for one or more assigned business capabilities and will already possess a deep understanding of how the assigned business capabilities are supported by process, people and technology. Senior Product Managers will also perform complex assignments lacking precedent and requiring creativity to implement. However, all Individual Contributors have the opportunity to blend and extend their expertise on different initiatives to further develop both the breadth and depth of their capabilities.

MAJOR RESPONSIBILITIES

Develop business capability(s) strategy based on legal/business requirements, business/market trends, and technology landscape; proactively create and champion plans to bring necessary changes to the business

Manage development of business capability(s) and related applications within Clinical Operations, including:

• Creating and maintaining the overall business applications strategy (people, process, capability & priority)
• Establishing effective operational system governance
• Providing business oversight of the continuous system improvement process, including prioritization of changes/enhancements
• Coordinating business readiness and adoption for new releases, including user acceptance testing, communications, change management and training activities

Partner across relevant stakeholder functions to:

• Drive business capability roadmap in their area and drive business case development
• Ensure assigned business application(s) remain fit for purpose through accountability for business needs along end-to-end business application lifecycle including design, implementation and continuous improvement
• Ensure adoption and benefits realisation, proactively identify and anticipate needs and ensure Clinical Operations systems effectively support business processes to meet current and future business needs

Support the conduct of internal audits and regulatory inspections and the implementation of system-related CAPA implementations

Lead negotiations and partner to establish partnerships, internally and externally

Represent PDG in appropriate systems governance bodies for non-PDG owned systems

Act as CSV Process Owner role to maintain validation status according to Roche CSV guidelines for GxP applications [as needed].

WHO YOU ARE

In Individual Contributors, we are looking for people who are nimble, curious, able to effectively collaborate and lend expertise to multi-functional teams and adapt quickly to competing priorities within their assigned area(s). We are also looking for people who are committed to continuing to make Genentech a great place to work, by seeking opportunities to develop their own and others’ expertise through ongoing mentorship and coaching.

• "Self-starter"; strong sense of responsibility with demonstrable comfort in an entrepreneurial environment

• Able to work effectively in a fluid, cross-functional, global matrixed environment and stand out as a successful collaborator

• Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships

• Good problem-solving ability, breaking down complex problems into distinct parts, managing uncertainty, understanding, anticipating interdependencies

• Able to proactively “connect the dots” by asking thought-provoking questions

• Objective when presenting insights and guiding decision-making; demonstrate good presentation skills by pairing sound analytics with storytelling

• Motivated to continuously improve performance; outcomes-focused and driven to achieve objectives

• Able to lean in and manage through change

QUALIFICATIONS

 

Minimum Qualifications

• Bachelor’s Degree (Advanced Degree in a related field is a plus)

• Understanding of Clinical Operations systems and processes

• Proven ability to handle ambiguity, work collaboratively with internal and external cross-functional teams

• Persuasive written and verbal communication skills, easily communicating complex ideas.

• Experience in influencing and negotiating at all levels and with diverse technical and non-technical groups to achieve delivery

• Demonstrated problem-solving and analytical skills and impeccable business judgment

• Demonstrated ability to identify and implement process improvements and project manage large, complex, strategic and operational initiatives

• Demonstrated program leadership experience and ability to lead organizational transformation

• Excellent time management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

• Self-motivated, self-starter and achievement driven

• Fluent English language skills

Additional Qualifications for Senior Product Manager

• Experience in launching and managing large, complex programs from inception to benefits realization involving multiple cross-functional stakeholders

• In-depth knowledge of Clinical Operations systems and processes; excellent understanding of the clinical operations system landscape

• Understanding of international regulations, processes and issues in drug development.  Includes sound understanding of GCP/GxP and related systems that support clinical trials and clinical operations processes

Preferred Qualifications

• Prior product management experience

• Experience leading global multi-functional and/or matrix teams and stakeholder/business partner interactions

• Extensive experience governing systems improvements and integrations in support of business processes

• Extensive understanding of the systems “product” lifecycle. Ability to interpret and articulate business needs to technical designers.

• Extensive experience in defining requirements/specifications and user acceptance testing for computer systems ≠

Other (e.g., Travel)

• Domestic and international travel: approximately up to 20%

Please note the closing date is Monday 22nd April 2019.

The Head of Systems will develop and drive the Business Systems Strategy that identifies and delivers the business capabilities that enable PDG to effectively plan and implement clinical studies on a global level. This requires close collaboration with Stakeholders across Clinical Operations (Therapeutic Areas, Country Clinical Operations, Business Insights & Analytics), plus engaging partners in Pharma Informatics, Portfolio and the broader Roche business (Research, Medical Affairs, GPS, Regulatory etc.)

You and your team will develop close partnerships that result in a detailed understanding of the clinical operations environment.  This understanding will be fundamental to driving key decisions to enhance and maintain the system landscape, and to ensure audit and inspection readiness. You may also act as the product manager for one or more assigned business systems that support specific capabilities and will already possess a deep understanding of how the assigned capability area(s)  are supported by process, people and technology.

MAJOR RESPONSIBILITIES

Drive/lead the development and implementation of strategies to support defined business  capability(s) based on legal/business requirements, business market/trends, and technology landscape; proactively create and champion the adoption of new technologies that enable the business and increase efficiency.

Provide strategic leadership in the development of business capability(s) and related applications within Clinical Operations, including:

Driving prioritisation, oversight and alignment of business systems and information related activities within SPE to ensure that PDG business needs are met

Identifying, prioritizing and reviewing system support for key business capabilities

Ensuring business capability needs are developed and structured in roadmaps that reflect priority, dependency, investment and timelines

Ensuring due diligence in managing complexity by driving critical thinking (e.g. root case) on problem solving

Serving as business decision maker for PDG systems and information landscape, product management infrastructure and application lifecycle planning

Representing SPE and/or PDG on appropriate governance bodies and internal/external work streams

Establish and maintain partnerships with internal and external stakeholders (e.g. BIA, Informatics, CCO, TAs, PDx functions, xRED, USMA, OTI, etc.)

Provide thought leadership in product management, lifecycle planning, and business capability mapping to support the creation, improvement, and oversight of PDG business applications and information solutions.

Partner with Informatics Head to ensure competitive analysis (comparison) and exploration of emerging technology and best practices

Oversee and enable the procurement of external data for benchmarking and vendor oversight, ensuring that PD/PDG has access to procured data for business insights.

Serve as member of the SPE Leadership Team (SPE LT).  Provide leadership to all members of the SPE Systems and Information Management team to maximize the capability and contribution of staff to deliver on their goals, objectives, development and talent management.

Partner with other PDG and PD functions to ensure inspection readiness and support for internal audits, regulatory inspections and the implementation of system-related CAPA implementations.

Simplify the information landscape to prevent CAPAs and inspection findings and enable compliance and faster delivery of clinical trials.

Ensure Business Process Owner CSV/Validation accountabilities are met by PDG (whether directly or in collaboration with others).

WHO YOU ARE

In Managers we are looking for people who are nimble, able to manage and lend expertise to multi-functional teams and adapt quickly to competing priorities within their area of focus. We are also looking for people who are committed to continuing to make Roche/Genentech a great place to work, by investing in people and providing ongoing mentorship and coaching to help them advance their expertise.

• Understand impact of change and new activity on the wider organization

• Understand the tools across SPE (and/or other departments) and when/how to apply them to address business questions

• Strong interpersonal skills and a consultative mindset, with the ability to influence without direct authority, and to develop strong partnerships  

• Ability to adapt to evolving internal and external pressures, provide focus and direction to successfully navigate complexity and uncertainty

• Ability to effectively manage change by explaining context, answering questions, and patiently listening to concerns

• Ability to connect with people in ways that generate enthusiasm and commitment; look for opportunities to build community and celebrate

• Understand what motivates people to perform at their best by recognizing the importance of their work

• Effective coach and mentor, with genuine interest in helping others develop; actively invest time to get to know people and what they do

• Skilled at managing and influencing peers and leaders

Minimum qualifications

• Bachelor’s Degree (Advanced Degree in a related field is a plus)

• Working knowledge of Clinical Operations systems and processes and familiarity with the clinical operations system landscape

• Broad knowledge of global pharmaceutical development, including understanding of organizational and market factors that affect the business

• Strong customer focus and experience in influencing and negotiating at all levels (including Senior Leadership) and with diverse technical and non-technical groups to achieve delivery

• Demonstrated ability to apply conceptual thinking, analytical thinking & problem solving approaches to complex business challenges and decision making processes

• Persuasive written and verbal communication skills, easily communicating complex ideas.

• Demonstrated program leadership experience and ability to lead organizational transformation

• A sound knowledge of and past experience working with product management methodologies for systems and information solutions, including lifecycle management, business capability mapping, to support business questions and decision making

• A proven track record of effective leadership of cross-functional staff and/or matrix management in a global organization and with virtual teams. Preferably with experience of working across diverse geographic areas, business settings and cultures

• Proven ability to handle ambiguity, work collaboratively with internal and external cross-functional teams

• Fluent English language skills

Preferred Qualifications

• Desired: MBA or advanced/post graduate Degree

• In-depth knowledge of Clinical Operations systems and processes; excellent understanding of the clinical operations system landscape

• Product Management Methodology qualifications preferred

• Understanding of international regulations, processes and issues in drug development.  Includes sound understanding of GCP/GxP and related systems that support clinical trials and clinical operations processes

• Prior product management experience

• Experience in launching and managing large, complex programs involving multiple cross-functional stakeholders

• Extensive experience governing systems improvements and integrations in support of business processes

• Extensive understanding of the systems “product” lifecycle. Ability to interpret and articulate business needs to technical designers.

• Experience in defining requirements/specifications and user acceptance testing for computer systems

Other (e.g., Travel)

• Domestic and international travel: approximately 20%

Please note the closing date for this role is Monday 22nd April 2019.

The Program Lead will lead and manage the programs in the Clinical (PDG) molecule enabling portfolio and maturing the program methodologies. This requires close collaboration with Stakeholders across Clinical Operations (Therapeutic Areas, Country Clinical Operations, Business Insights & Analytics), plus engaging partners in Pharma Informatics, Portfolio and the broader Roche business (Research, Medical Affairs, GPS, Regulatory etc.)

You will develop close partnerships that result in a detailed understanding of the clinical operations environment.  This understanding will be fundamental to driving key decisions and ability to act as a trusted advisor to address, develop and deliver on business challenges.

MAJOR RESPONSIBILITIES

Lead and deliver complex global PDG business objectives across multiple programs that simplify how we conduct our business, enable and optimize innovation in clinical trials.

• Apply advanced knowledge in program/project management or strategic consulting to independently address unusually complex problems.
• Develop, evaluate and manage program design, business cases and cost/benefit analyses.
• Drive strategic discussions with business partners to define and deliver program/project scope and charter.
• Work with stakeholders to define approach to project delivery, manage execution of programs and ensure delivery of projects in the programs on budget, on schedule and with deliverables that meet or exceed customer expectations.
• Implement and oversee risk management practices across programs.
• Provide strategic direction and serve as a consulting partner to business functions to improve the success of the solution.

Drive the continuous improvement of the Molecular Enabling Portfolio, and ensure that Program, Project and Change Methodology and tools within PDG are aligned with the PD organization.

• Ensure that PDG programs are aligned with identified PDG Priorities and key Clinical Capabilities.
• Partner with business stakeholders to ensure organizational change strategy and management are embedded through programs and the organization to enable sustainable transformation.
• Proactively communicate with stakeholders and senior leaders regarding program benefit realization, status, financial health, risks and mitigation of issues, and dependencies across programs where the Program Leader is responsible.
• Connect program teams to PD and PDG strategic goals and ensure the solutions/outcomes support these goals.

Manage relationships within external suppliers for the purposes of delivering one or more PDG Molecular Enabling projects or programs.

• Work with preferred resource vendors to identify and procure necessary contract resources on projects.
• Monitor and report on the performance of selected vendors to ensure delivery in line with contractual obligations and performance metrics.
• Oversee the interaction between vendors and internal programs to provide adequate visibility of interdependent initiatives and programs.
• Provide feedback on external vendors, to appropriate oversight bodies, to review, report on and revise contractual agreements as necessary.

WHO YOU ARE

In Individual Contributors, we are looking for people who are nimble, curious, able to effectively collaborate and lend expertise to multi-functional teams and adapt quickly to competing priorities within their assigned area(s). We are also looking for people who are committed to continuing to make Genentech a great place to work, by seeking opportunities to develop their own and others’ expertise through ongoing mentorship and coaching.

• "Self-starter"; strong sense of responsibility with demonstrable comfort in an entrepreneurial environment

• Able to work effectively in a fluid, cross-functional, global matrixed environment and stand out as a successful collaborator

• Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships

• “Strong problem-solving ability, breaking down complex problems into distinct parts, managing uncertainty, understanding, anticipating interdependencies

• Systems thinker - able to proactively “connect the dots” by asking thought-provoking questions

• Objective when presenting insights and guiding decision-making; demonstrate good presentation skills by pairing sound analytics with storytelling

• Motivated to continuously improve performance; outcomes-focused and driven to achieve objectives

• Able to lead and manage through change

QUALIFICATIONS

 

Minimum qualifications

• Bachelor’s Degree

• Five or more years of related experience in program/project management or strategic consulting in highly-complex cross-functional projects is required

• Proficiency with common project management tools is required.

• Broad knowledge of global pharmaceutical development, including understanding of organizational and market factors that affect the business

• Strong customer focus and experience in influencing and negotiating at all levels (including Senior Leadership) and with diverse technical and non-technical groups to achieve delivery

• Demonstrated ability to apply conceptual thinking, analytical thinking & problem solving approaches to complex business challenges and decision making processes

• Persuasive written and verbal communication skills, easily communicating complex ideas.

• Demonstrated program leadership experience and ability to lead organizational transformation

• A sound knowledge of and past experience working with product management methodologies for systems and information solutions, including lifecycle management, business capability mapping, to support business questions and decision making

• A proven track record of effective leadership of cross-functional staff and/or matrix management in a global organization and with virtual teams. Preferably with experience of working across diverse geographic areas, business settings and cultures

• Proven ability to handle ambiguity, work collaboratively with internal and external cross-functional teams

• Fluent English language skills

Preferred Qualifications

• Degree in a scientific discipline is preferred.

• Desired: MBA or advanced/post graduate Degree

• Experience in drug development projects pharmaceutical/biotech industry is strongly preferred; experience supporting a global team is a plus.

• PMP (Project Management certification) or equivalent, Change Management certification and Process certification (e.g. Lean/Six Sigma) is a plus.

• Understanding of international regulations, processes and issues in drug development.  Includes sound understanding of GCP/GxP and related systems that support clinical trials and clinical operations processes

• In-depth knowledge of Clinical Operations systems and processes; excellent understanding of the clinical operations system landscape

• Experience in launching and managing large, complex programs involving multiple cross-functional stakeholders

Other (e.g., Travel)

• Domestic and international travel: approximately 2 trips per year.

Please note the closing date is Monday 22nd April 2019.

The Head of Program Management will oversee the development, and management of projects, initiative, and/or programs in the Clinical (PDG) molecule enabling portfolio as appropriate. This requires close collaboration with Stakeholders across Clinical Operations (Therapeutic Areas, Country Clinical Operations, Business Insights & Analytics), plus engaging partners in Pharma Informatics, Portfolio and the broader Roche business (Research, Medical Affairs, GPS, Regulatory etc.)

You and your team will develop close partnerships that result in a detailed understanding of the clinical operations environment.  This understanding will be fundamental to driving key decisions and ability to act as a trusted advisor to address, develop and deliver on business challenges.

MAJOR RESPONSIBILITIES

Establish Program Management best practices and ensure alignment between the Clinical Capabilities portfolio and overall PDG strategies and goals.

Build, drive and maintain processes for tracking initiative and portfolio information that will support Clinical operational governance and decision-making. Define and implement strategies, operating models, processes and tracking systems for portfolio, program & project performance, budget, and resources.

Enable effective and timely decision making by providing portfolio and program reporting, proactively ensuring visibility of program and portfolio information, issues, risks and opportunities and providing recommendations to the Clinical leadership teams.

Manage relationships with key internal and external stakeholders to leverage best working practices and establish, ensure alignment and improvement to program management processes. Actively communicates and manages relationships with functional area and cross-functional teams to promote understanding, ownership and support of program and portfolio information.

Partner within PDG and across PD, as needed, to develop, manage and prioritize, program performance measures, analytics and data visualizations to generate evidence and business insights that enable operational efficiency, optimal decision-making and targeted communications to stakeholders.

Provide strategic context to program/project teams to ensure alignment to Clinical strategic roadmap, clarify program/project interdependencies to avoid misalignments among business improvement strategies and help create greater efficiencies.

Lead the planning and budgeting process across programs, ensuring sound business cases.

Accountable for the continuous improvement of the Molecular Enabling Portfolio, and ensure that Program, Project and Change Methodology and tools within PDG are aligned with the PD organization.

Accountable for ensuring that PDG programs are aligned with identified PDG Priorities and key Clinical Capabilities.

Accountable for ensuring the implementation of change management strategy and guidance to ensure sustainable transformation through programs.

Accountable for ensuring Change Management best practices are incorporated across PDG’s Molecular Enabling Portfolio.

Proactively communicate with stakeholders and senior leaders regarding program benefit realization, status, financial health, risks and mitigation of issues, and dependencies across all program teams.

Accountable for ensuring PD and PDG strategic goals and communicated and Molecular Enabling Projects support the achievement of these goals.

Lead efforts to ensure appropriate resourcing is available for PDG projects and initiatives.

Drive a strategy to ensure an effective supply of external resources can be leveraged across projects based on business need and skill level.

Influences policy and procedures covering the selection of suppliers, tendering and procurement, promoting good practice in third party management.

Deploys highly developed skills to identify external partners, engaging with professionals in other related disciplines (e.g. procurement specialists, lawyers) as appropriate.

Partner with Procurement and Vendor Management teams to define SPE vendor communications, conduct supplier analysis, assess program effectiveness, and manage and maintain the relationship between SPE and the supplier.

Evaluate potential suppliers using developed and agreed criteria to support alignment and understanding of the expectations and requirements of engagement.

Measures the perception about how services are delivered, how this influences the performance of the supplier and their perception of own organisation’s performance.

Ensures that processes and tools are in place to conduct benchmarking.

Promotes good practice with regard to third party information security.

Works with business partners to approve potential suppliers using developed and agreed criteria to support alignment and understanding of the expectations and requirements of engagement.

Manage outward communication to vendors to facilitate understanding and awareness of organisational strategic direction, changes and challenges.

Provide leadership to all members of the Program Management team to maximize the capability and contribution of staff to deliver on their goals, objectives, development and talent management.

WHO YOU ARE

In Managers we are looking for people who are nimble, able to manage and lend expertise to multi-functional teams and adapt quickly to competing priorities within their area of focus. We are also looking for people who are committed to continuing to make Roche/Genentech a great place to work, by investing in people and providing ongoing mentorship and coaching to help them advance their expertise.

• Understand impact of change and new activity on the wider organization

• Understand the tools across SPE (and/or other departments) and when/how to apply them to address business questions

• Strong interpersonal skills and a consultative mindset, with the ability to influence without direct authority, and to develop strong partnerships  

• Ability to adapt to evolving internal and external pressures, provide focus and direction to successfully navigate complexity and uncertainty

• Ability to effectively manage change by explaining context, answering questions, and patiently listening to concerns

• Ability to connect with people in ways that generate enthusiasm and commitment; look for opportunities to build community and celebrate

• Understand what motivates people to perform at their best by recognizing the importance of their work

• Effective coach and mentor, with genuine interest in helping others develop; actively invest time to get to know people and what they do

• Skilled at managing and influencing peers and leaders

QUALIFICATIONS

 

Minimum qualifications

• Bachelor’s Degree this is redundant with preferred qualifications

• Ten or more years of related experience in program/project management or strategic consulting in highly-complex cross-functional projects is required.

• Broad knowledge of global pharmaceutical development, including understanding of organizational and market factors that affect the business

• Strong customer focus and experience in influencing and negotiating at all levels (including Senior Leadership) and with diverse technical and non-technical groups to achieve delivery

• Demonstrated ability to apply conceptual thinking, analytical thinking & problem solving approaches to complex business challenges and decision making processes

• Persuasive written and verbal communication skills, easily communicating complex ideas.

• Demonstrated program leadership experience and ability to lead organizational transformation

• A sound knowledge of and past experience working with product management methodologies for systems and information solutions, including lifecycle management, business capability mapping, to support business questions and decision making

• A proven track record of effective leadership of cross-functional staff and/or matrix management in a global organization and with virtual teams. Preferably with experience of working across diverse geographic areas, business settings and cultures

• Proven ability to handle ambiguity, work collaboratively with internal and external cross-functional teams

• Fluent English language skills

Preferred Qualifications

• Experience in drug development projects pharmaceutical/biotech industry is strongly preferred; experience supporting a global team is a plus.

• PMP (Project Management certification) or equivalent, Change Management certification and Process certification (e.g. Lean/Six Sigma) is a plus.

• Desired: MBA or advanced/post graduate Degree

• Understanding of international regulations, processes and issues in drug development.  Includes sound understanding of GCP/GxP and related systems that support clinical trials and clinical operations processes

• In-depth knowledge of Clinical Operations systems and processes; excellent understanding of the clinical operations system landscape

• Experience in launching and managing large, complex programs involving multiple cross-functional stakeholders

Other (e.g., Travel)

• Domestic and international travel: approximately 4 trips per year.

Please note this role closes on Monday 22nd April 2019.

This position will provide high-level administrative support within the Managed Care & Customer Operations (MCCO) organization. With minimal direction, this candidate will be responsible for a wide range of administrative duties as outlined below, with a strong emphasis on organization and proactive coordination of activities.

With high attention to detail, plans, coordinates and manages a complex calendar. Organizes management travel, channeling communication and/or materials within the department. Actively participates in planning and execution of quarterly Access Solutions All Hands meetings, leads planning of department activities and events (social, celebratory), coordinates monthly leadership roundtable luncheons and quarterly new hire breakfast, and plans leadership offsite meetings in collaboration with Access Solutions Operations Team. Provides support on editing and formatting management documents, materials and/or presentations, gathering information or conducting analyses to support the Vice President and other management team members. 

• Complex calendar management including meeting scheduling, resolution of scheduling conflicts and scheduling appointments with external guests and interviews as necessary
• Schedules and coordinates teleconferences, travel, onsite/offsite meetings
• Process payment request, expense reports and purchase orders
• Streamline and reduce unnecessary administrative or operational burdens for senior management
• Act as the team "go-to-person" for general operational or administrative questions or other inquiries
• Represent Genentech, Vice President and team (as appropriate) with the utmost professionalism
• Exercise independent judgment and discretion with sensitive/confidential and proprietary information
• Leads administrative staff in Access Solutions (sharing information and other relevant resources, helping others as needed, etc.) to ensure administrative requirements are met by the team of administrative professionals
• Manages and aligns AS administrative assistant policies and service level agreements
• Leads and encourages best practices processes across administrative team
• Ensure all assigned work is completed on-time and without compromise to quality
• Act in compliance with all laws, regulations and policies
• Utilize only approved resources and messages to meet goals and targets
• Work collaboratively, effectively and efficiently with all internal/external partners & stakeholders
• Participate, as and when needed/appropriate, in cross-functional or other project teams; helping the overall business of MCCO, Commercial and Genentech to continuously evolve, improve & excel

The successful candidate will demonstrate the following competencies critical to this role:

• Technical and business expertise - Applies emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area
• Communication – Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness
• Teamwork and collaboration – Creates an atmosphere of openness and trust; collaborates; offers support and encouragement

Qualifications

• Bachelors Degree is preferred. High school diploma or GED required.
• 5+ years of senior level administrative assistant experience in a fast paced environment, preferably at the Senior Management or Executive level
•  Individual must possess strong, positive interpersonal and collaboration skills
• Demonstrated experience organizing and coordinating a large team of administrative professionals is preferred
• Able to successfully manage multiple projects simultaneously and meet set deadlines
• Ability to handle routine and impromptu assignments with minimal supervision yet displays flexibility in taking direction from team and co-workers
• Excellent communication skills (both written and verbal)
• Able to work independently, display proactive problem solving and good judgment within agreed parameters
• Exercise discretion with sensitive/confidential information
• Ability to remain poised in a fast-paced environment is essential
• Must demonstrate outstanding computer skills and specific proficiencies with Microsoft Word, Excel and PowerPoint

*LI-COMM-MG1

PCD STRATEGY MANAGER / SENIOR STRATEGY MANAGER, GIO (IMMUNOLOGY & OPHTHALMOLOGY)

The Position

In this position, you will be responsible for developing, managing, and maintaining the pricing, contracting, and distribution strategies for GIO (Immunology & Ophthalmology) products. This includes effectively leading cross-functional strategy development teams in a dynamic environment, establishing clear and effective communication across the organization, building collaborative relationships, particularly with brand and field-based account managers, and developing, synthesizing and communicating scenario analysis/modeling for overall strategic, financial and legal viability.

Specifically, you will be primarily accountable for consistently, effectively:

• Exploring, developing and maintaining any potential GIO pricing approaches.
• Exploring, developing and maintaining any potential GIO contracting strategies (including payer segments, provider segments, etc.).
• Leading and/or supporting ongoing market research efforts to inform pricing and contracting strategies, which may include selecting, contracting, managing, and providing strategic direction for a vendor team.
• Monitoring, evaluating and refining pricing and contracting models.
• Exploring, developing and maintaining channel distribution strategies while balancing patient access, control, and support needs.
• Building relationships across the business, working collaboratively with all internal/external customers, particularly with relevant GIO brands and MCCO partners and other stakeholders, and often leading cross-functional strategy core teams.
• Providing relevant customers, partners and other stakeholders with strategic analytics, insights, modeling and scenario development and recommending optimal solutions to meet Genentech's strategic, financial and operational objectives. Includes articulating operational complexities, operational pull-through, implications, requirements, impacts and the like for all recommended strategies.
• Supporting development of Squad, US Leadership Team (USLT) and other required deliverables and ensuring collaboration across US Commercial.

The successful candidate will demonstrate the following competencies critical to this role:

• Communication: able to frame information accurately and concisely, effectively sending and receiving messages when interacting with others.
• Teamwork & Collaboration: have a drive to work with peers, partners, and others, including individuals outside their own team and functional area to positively impact business performance and optimize the input of those involved.
• Strategic Agility: increasingly think beyond his/her own area and in a longer-term context. They translate vision into a direction that adds distinct value to Genentech and builds competitive advantage. Complex thinking abilities are required to adapt a given strategy with agility.
• Managing Change: Accepts change as positive and adapts accordingly, ensuring that changes are thoroughly and smoothly implemented, and that the lasting benefits of change are achieved.

Qualifications:

• Bachelors Degree (general business, healthcare, science, engineering, policy, economics, or finance disciplines are preferred)
• MBA or other related Graduate-level degree is preferred; healthcare discipline is a plus.
• An average of 4 years of work experience in the pharmaceutical/biotechnology industry. Managed Care experience preferred, account management or consulting experience a plus.
• Business travel required for regular internal and external business meetings (<20% travel)

Additional Qualifications Detail

Overall:

• Collecting, interpreting and disseminating internal and external pricing and contracting information to help internal customers, partners and other stakeholders with timely decision-making, that align with brand opportunities and/or risks
• Providing in-depth, cumulative legal, regulatory, market, industry and other relevant macro analyses and insights that have real or potential brand or portfolio-wide implications to current or future strategies
• Supporting brand pricing, contracting and distribution strategy teams, as needed, in developing internal and external communications that define and educate others in regards to Genentech's relevant philosophies and practices
• Working with brand and other portfolio partners to align brand, pricing, contracting and distribution strategies for optimal market performance
• Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget

Strategy/Planning:

• Act as a subject matter expert on pricing and contracting strategy development and implementation in the pharmaceutical/biotechnology industry
• Act as a subject matter expert on assigned GIO brands, managed market trends in this space, and implications to pricing and contracting strategy 
• Stay abreast of macro trends in the healthcare environment that potentially impact current and/or future product pricing, contracting and distribution and associated strategies across Genentech’s product portfolio
• Represent Genentech pricing, contracting and distribution on relevant Genentech and Roche global teams and participate in various business planning meetings and processes
• Conduct or commission market research and competitive analysis, as this relates to pricing and contracting. Analyze, consolidate and synthesize research and other analytics to provide a clear perspective and actionable insights to support brand and contracting strategy development
• As assigned, represent Genentech’s overall pricing and contracting strategies, philosophies and practices on Global Pricing & Market Access teams, projects and recurring communications/interactions to ensure Genentech’s alignment with and awareness of Roche global strategies, philosophies and practices
• Work with internal stakeholders to develop strategies and recommendations to optimize Genentech's pricing and contracting effectiveness, patient access and competitive advantage:
• Develop detailed quantitative and qualitative analyses and modeling of brand strategies and recommendations
• Prepare internal reports and presentations and review with key internal customers, partners and other stakeholders, including global partners
• Evaluate immediate-, medium- and longer-range business and financial impacts of brand. Includes articulating operational complexities, operational pull-through, implications, requirements, impacts and the like for all recommended strategies
• Identify and recommend metrics to assess pricing and contracting strategy effectiveness
• Where appropriate, establish and manage cross-functional project teams and any external vendor partners
• Establish and obtain approvals for project objectives, scope, deliverables, resourcing, timing and success metrics
• Steward projects from concept through to completion. Including advising internal customers, partners and other stakeholders on project results, implications and actions required
• Take the lead in ensuring project outcomes are integrated with relevant strategies, processes, systems or other mechanisms and tools in a timely and targeted manner

Operations:

• Track and communicate pricing and contracting trends and issues to internal customers, partners and other stakeholders, includes global partners
• As assigned, help develop understanding, knowledge, skills and abilities for other team members and/or train and educate various internal customers, partners or other stakeholders on pricing and contracting strategies, research, analysis, methodologies, departmental processes, systems, tools, and the like
• Conduct regular and ongoing strategy performance assessment and reporting
• Respond to internal/external inquiries regarding Genentech's pricing, contracting and distribution strategies, philosophies and practices
• Complete planned and/or ad hoc research projects
• As assigned, lead or otherwise complete other special projects, including market research

Knowledge

• Strong knowledge/understanding of drug contracting, private and public payers and the distribution channels
• Demonstrable knowledge of the current policies and guidelines that affect managed care contracts and contract administration, pricing and payment adjustments
• Demonstrable knowledge of systems and reporting mechanisms that support contract administration particular to the pharmaceutical/biotechnology or related industry
• Demonstrable knowledge of the different state and federal government agencies that purchase pharmaceutical/biotechnology or related industry products
• Working knowledge of relevant pricing and contracting strategy development methodologies and modeling (quantitative and qualitative)

Skills/Abilities

• Proven track record of meeting or exceeding objectives and goals
• Applies technical and business expertise effectively & efficiently adapt to changing circumstances while maintain the long-term vision and objectives
• Strong communication & presentation skills; appropriately tailors communications to varying audiences, both internal and external. Ability to distill and communicate complex topics, issues, and analytical components to others with varying backgrounds and expertise.
• Demonstrates exceptional interpersonal skills including the ability to lead, manage people and projects and build effective relationships with internal and external partners
• Links his/her responsibilities with the mission of the organization and regularly adapts to reflect changing circumstances. He/she will possess strong decision making skills and focus on activities that provide the most value.
• Strong analytical and problem-solving capabilities and skills
• Strong financial & business acumen for analysis, modeling and tracking of quantitative and qualitative business data and metrics; to include the ability to extrapolate meaning from such analyses, modeling and tracking
• Strong attention-to-detail
• Demonstrable project management skills: proven ability to manage multiple tasks to conclusion, on- time and without compromise to quality of work output
• Demonstrable orientation toward process development and management
• Willingness to partner with others and a proven track record of collaborative work relationships
• Can influence others without authority
• Demonstrable orientation to teamwork and customer service
• Demonstrated interest and ability to assist in the development of other team members
• Strong customer orientation/focus

Start date: Summer 2019

Length: 6 months

Start date: Summer 2019

Length: 6 months

Global Procurement - Direct Procurement Pharma is responsible for maximizing the value delivered to Genentech of across to Drug Substance and Drug Product portfolio of cGMP direct material goods and services. Direct Materials are those raw materials from suppliers that directly impact our drug products (eg vials, stoppers, filters, chemicals, resins, etc)

The intern will support the Global Head of Direct Materials, BioDS to:

Manage a global and local US team operating portfolio: including projects, supplier relationship management, contracts and forecasting.

• Lead and/or support development and deployment of new and/or improved processes
• Lead the planning of deliverables and planning process for Global TOP DM, including goal setting and monitoring
• Manage business meetings  
• Key Direct Material Suppliers to monitor metrics, forecasts, and supply to control commercial supply and quality performance.
• Provide effective communication to procurement network and stakeholders
• Provide support for special projects including efficiency, long range planning, capacity planning, strategic analysis, and organizational fitness activities and change management
• Develop and implement projects internally (within Roche) and externally (with suppliers) for operational optimization, quality improvement, global network alignment, and cost savings initiatives.

In addition, the Intern will provide support to Local US and Global Category Managers. He/she will have the opportunity to learn and support operational procurement activities including but not limited to: leading cross-functional teams, developing/executing global category strategies, implementing projects internally (within Roche) and externally (with suppliers) for operational optimization, quality improvement, global network alignment, new technologies, and cost savings initiatives.

What's in it for you: You will learn the different aspects of working in Technical Procurement, including but not limited to: Cross-functional team project development and deployment, Supplier Relationship Management and development, and on the job training/learning direct material sourcing management. Key learnings throughout the year will be:

1. Understanding of Direct Materials Supplier Management at Roche

2. Technical understanding of direct material impact on the biotech business, product, cGMP practices and Quality systems

3. Project management skills as project lead and participant

4. Relationship management, facilitation and influencing skills of cross-functional teams

5. Operational/tactical procurement activities including spend analysis, cost savings project management, performance metric trending, and beyond!

Start Date: Summer 2019

Work Hours: 40 hours per week 

Location: South San Francisco Campus

Length of Assignment: 10-12 weeks

Job Description:

The iLabs team is responsible for identifying and evaluating breakthrough manufacturing technologies and as well as maintaining a connected, multi-disciplinary technology innovation community across Roche's Pharma Technical Global Operations.

Responsibilities will include:

• Facilitate, refine, and execute experiments collaboratively and creatively with customers, suppliers, and stakeholders to demonstrate proof-of-concept and feasibility of a novel cell culture manufacturing technology
• Participate in global and cross-functional teams to connect technology evaluations within the current Roche manufacturing network to foster a multi-disciplinary and innovative technology community
• Participate in creating iLabs business processes, including assisting with establishing: 1) global project management strategies, 2) developing portfolio organization software, and 3) creating Environment, Health, and Safety best practices.

Qualifications:

• Current student or B.A./B.S./M.S. in Chemical/Biochemical Engineering, Biotechnology, or Life Sciences
• Passionate and creative team member willing to work in dynamic environment to build relationships with customers, suppliers, and stakeholders
• Drive for results, manage change, and work independently as well as in matrixed team environment
• Excellent organization and communication skills (both written and verbal)
• Desire to work in a global environment including capability to support domestic and international teams