The VP and Head of Pharma Technical Development Biologics United States (PTDU) is responsible for setting the strategic direction of the US Biologics technical development organization and for driving effective execution of its goals. The VP will be responsible for leading all technical development activities for biologics including bioprocess, pharmaceutical, device development, analytical methods development, quality control, and Pilot plant operations and engineering for large molecules carried out in the US. The organization is also responsible for providing technical support and oversight at CMOs and internal manufacturing sites for commercial products.
The VP will build a sustainable high performance organization fostering an environment of innovation, collaboration, continuous improvement and people engagement. She/he will foster a partnership with key stakeholders in Research, Development, and Manufacturing. She/he will be a member of the PTD Leadership team to develop and implement the strategies needed to effectively and efficiently deliver the company’s exciting, large, diverse and accelerating pipeline.
Key accountabilities Include:
Leads team consisting of ~800 permanent and contingent technical and scientific employees based in South San Francisco. Attract, retain and engage world class technical talent.
Accountable for CMC (Chemistry, Manufacturing and Controls) deliverables related to the Genentech originated biologics pipeline.
Provide scientific strategies and sound business input to project teams and the Technical Research & Development community.
Collaborate effectively with partners in Technical Development, especially PTDE (Europe) and Genentech Research and Early Development (gRED) in developing aligned strategies and concepts for the development of Biologics Drug Substance, Drug Product, drug delivery and devices.
Ensure compliance with internal and external requirements in all aspects of clinical manufacturing and quality operations.
Build and maintain effective collaboration with technical functions in Research, Technical Development, Commercial Manufacturing and Quality to ensure seamless technology transfer and handover of projects and knowledge.
Accountable for technical/laboratory-based aspects of commercial manufacturing processes and analytical support, including significant post-licensure process and assay improvements, and technology transfer.
Engage PTDU in continuously improving productivity, performance and striving for excellence in development of Biologics. Actively lead deployment of our LEAN production system to continue to eliminate waste in our processes. Leverage LEAN to improve efficiency in the organization and to accelerate our development work.
Provides site leadership for the PTD SSF community including employee and manager development activities, active involvement within the larger Genentech community, facility and space planning, and SHE.
Chair the Early Stage Technical Development Committee (ESTDC) for Genentech biologics and serves as member of Late Stage Technical Development Committee (LSTDC) and other global governance bodies.
Manage budget planning to meet annual targets.
Who You Are
+15 years multi-disciplinary work experience with at least 5years experience leading large and highly technical organizations preferably inBiotechnology/Pharmaceutical industry (process development,technology transfer, manufacturing, etc.)
PhD in life sciences, biological engineering or equivalentrelevant work experience
Proven track record of excellence in people management andability to build, engage and develop high performing teams
Demonstrated ability to successfully manage largeorganizations, including people, financials and business processes and toprovide focus and direction to navigate in fast moving environment
Extensive knowledge in multiple facets of biologicstechnical development
Outstanding knowledge of FDA regulatory guidelines andstandards for biopharmaceutical process development and manufacturing andoutstanding knowledge of cGMP, OSHA, and EHS practices
Proven leadership skills and ability to positively influencecolleagues and key stakeholders
Strong track record of collaboration and relationshipmanagement
Excellent communication skills, ability to communicateeffectively to many levels and functions and to encourage direct and opendialog
Demonstratedability to be customer- and stakeholder-focused, working collaboratively and across boundaries.
Ability tothink strategically and an effective communicator; able to convey controversialinformation and decisions appropriately
Some international travel required
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.