South San Francisco
California, United States of America
Location: Oceanside, Vacaville or South San Francisco
The head will lead a team of 5-6 senior level global Drug Substance Technical Leaders, DSTLs (6-8 including part time DSTLs) located throughout the US Drug Substance manufacturing sites in the Biologics network. The focus of this group will primarily be on the products that have a deeper technical history in the US region while managing global interactions with the sites in scope. The scope of the position currently includes up to 11 marketed biologics (Actemra, Halozyme, Herceptin, Lucentis, Rituxan, Nutropin, Ocrevus, Pulmozyme, Perjeta,TNKase and Xolair) and increasing in number as pipeline products enter commercial portfolio,. The specific combination of products will evolve time as we organize the overall portfolio of marketed products and new products are added to the portfolio of marketed products. This is a key leadership role within PTIB (Biologics organization within PTI) as part of our mission to improve product health, transfer/advance technical knowledge from commercialization to the end of life cycle and accelerate implementation of new technology into our manufacturing processes.
The Group leader may also serve as a DSTL for new products until a DSTL is assigned and in that capacity will provide technical leadership across the Biologics manufacturing network for the assigned product. The group leader will collaborate closely with stakeholders to develop the necessary infrastructure and capability for TPM and PTI including leading strategic initiatives to ensure consistent product management approach across the portfolio of products. The group leader will support and develop the team of DSTLs and also serve as the representative of the DSTL/TPM organization on network teams such as MPET and cross functional committees like CJAR as well as cross functional TPM initiatives. The group leader will work very closely with the technical groups in the Biologics sites, PTD and other TPM functions (Quality, supply chain, regulatory, TPLs) to ensure that the needs and feedback from stakeholders is understood and responded to in building the product management capability. The group leader and his/her team will support DSTL responsibilities during the warranty period as per the CMContinuum expectations and implement CMC Continuous Improvement (CMC CI) solutions. This role serves as a critical product technical link among PTD, PTM and PTS for the group of products in scope of the role. The group leader will work closely with the other group leaders in the PTIB organization to ensure global alignment of relevant practices for end-to-end focus on product technical activities. In support of the TPM goals, this role will interface with the small molecule DS/DPTL counterparts to ensure alignment between Biologics and small molecule TPM practices. This role will report to the Head of PTI Biologics (PTIB).
Responsibilities as Group leader:
Responsibilities as DSTL include technical ownership for product issues, drive execution of process health improvement initiatives and provide technical leadership to product lifecycle management activities.
Qualification and Leadership Skills:
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.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
These are our stories - stories of the obstacles and opportunities that define and celebrate the unique people at Genentech