VP, Technical Development Biologics US

Company: Genentech
Location: San Francisco
Posted on: April 10, 2021

Job Description:

The Vice President, 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 implementation 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 biologics cGMP manufacturing 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 and sustain a high performance organization fostering an environment of innovation, collaboration and people engagement. She/he will be a key relationship manager with stakeholders in Genentech Early Research and Development (gRED), global Product Development (GPD), Global Product Strategy (GPS), and Pharma Technical Operation (PT), and will work closely with the other PTD functions. 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 maturing pipeline and bring more benefits to patients with reduced cost to society. Key accountabilities Include: Build and lead team consisting of -770 permanent and contingent scientific and technical employees based in South San Francisco. Attract, develop, retain and engage world class technical talent. Accountable for CMC (Chemistry, Manufacturing and Controls) deliverables related to the gRED originated biologics pipeline. Provide scientific strategies and sound business input to project teams and the Technical Research & Development community. Ensure compliance with internal and external requirements in all aspects of clinical manufacturing and quality operations. Build and maintain effective collaborations with gRED, PTD, GPD, GPS, and PT (Commercial Manufacturing, Quality, Supply Chain, Regulatory) to ensure seamless product development, technology transfer, and technical lifecycle management for commercial products. Collaborate effectively with partners in Technical Development, especially PTDE (Europe), Global MSAT, and gRED in developing aligned strategies and concepts for the development of Biologics Drug Substance, Drug Product, drug delivery and devices. Accountable for technical/laboratory-based aspects of certain commercial manufacturing and analytical support, including significant post-licensure process and assay improvements, and technology transfer. Manages budget (- 200 M CHF) planning and actuals to meet agreed targets (FTEs, PVCs, Capex). Engage PTDU in continuously improving productivity, performance and striving for excellence in development of Biologics. Actively cultivate an inclusive working environment and lead organization to improve efficiency in the organization by unleashing the full potential of the staff and to accelerate our innovative and development work by putting patients at the center. Provides site leadership for the PTD SSF community (- 1100 FTEs) including cultivating culture and employee engagement activities, and active involvement within the larger Genentech community, facility and space planning, and SHE.-- Chairs the Early Stage Technical Development Committee (ESTDC) for gRED biologics and serves as a member of the Late Stage Technical Development Committee (LSTDC). Member of gRED ESPC and other global governance bodies. Qualifications & Experience: 15+ years multi-disciplinary work experience with at least 5 years experience leading large and highly technical organizations preferably in Biotechnology/Pharmaceutical industry (process development, technology transfer, manufacturing, etc.) PhD in life sciences, chemical engineering or equivalent relevant work experience Proven track record of excellence in people management and ability to build, engage and develop high performing teams Demonstrated ability to successfully leading large organizations, including people, financials and business processes and to provide focus and direction to navigate in fast moving environment Extensive knowledge in multiple facets of biologics technical development Outstanding knowledge of FDA regulatory guidelines and standards for biopharmaceutical process development and manufacturing and outstanding knowledge of cGMP, OSHA, and EHS practices Proven leadership skills and ability to positively influence colleagues and key stakeholders Strong track record of collaboration and relationship management Excellent communication skills, ability to communicate effectively to many levels and functions and to encourage direct and open dialog Demonstrated ability to be customer- and stakeholder- focused, working collaboratively and across boundaries. Ability to think strategically and is an effective communicator; able to convey controversial information and decisions appropriately #LI-DW1 Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. The next step is yours. To apply today, click on the "Apply for this job" 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 .

Keywords: Genentech, San Francisco , VP, Technical Development Biologics US, Executive , San Francisco, California