Head of Technical Leaders, Drug Substance, US, PTI Biologics

South San Francisco
California, United States of America

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The Position

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:

  • Strategically build, develop and lead team of DSTLs for marketed biologics product portfolio in scope.
  • Develop the infrastructure needed to manage marketed biologics lifecycle technical activities. Ensure consistency of approach with the other Biologics DS/DPTL group leaders and small molecule teams as well as corresponding TPM functions.
  • Provide scientific and technical input to facilitate decision making for biologics marketed product management. Provide technical leadership and ad-hoc MSAT representation on various cross functional teams for product focused topics (ex, product focused topics at BQC, CJAR, other TPM initiatives)
  • Partner closely with counterparts in the QPL, TRL and PSCO organization to build infrastructure and support PT’s end-to-end product focused transformation and ensure alignment of priorities and practices with respect to the marketed products technical activities.
  • Partner closely with various PTD functions to ensure technical knowledge transfer from development to product teams.
  • Support the development of the Technical Leaders and ensure a robust succession pipeline of technical leaders.
  • Provide guidance to DSTLs/DPTLs for development of Product Technical Plans and Product Strategic Plans and then take portfolio approach to ensure balance of short term product issue resolution and long terms strategic perspective.
  • Identify multi product technical issues and guide resolution of significant issues.
  • Lead DSTLs for single site products in a matrix environment to ensure that we are developing a common TPM approach for all biologics products.
  • The group leader roles are expected to have a cross-product focus to ensure that globally we are applying common tools across products such as implementation of track and trend programs, product risk management, product and process health monitoring, process documentation such as manufacturing process specifications and product history files.
  • Review various regulatory submissions for products in scope.
  • Interface with PTIM and PTD groups to ensure product level actions needed to implement new technology and process improvements are incorporated in the product plans.

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:

  • Undergraduate degree in life sciences/engineering required, advanced degree in life sciences/engineering preferred.
  • 15 or more years of experience (including advanced degree) in bio-pharmaceutical industry specializing in either drug substance or drug product; including experience across various disciplines in local and global roles strongly preferred.
  • 5 or more years of people management experience including leading cross-functional teams
  • Demonstrated expertise (technical and/or operational) in drug substance or drug product processes required to be able to provide strong technical leadership and guidance to the Drug Substance technical product teams. Knowledge of devices is a plus.
  • Experienced with technology transfers, process validation, authoring regulatory submissions, Health Authority interactions, inspections, and resolution of global quality product/process investigations.
  • Strong knowledge of cGMPs, Health Authority regulations, and Quality Systems.
  • Ability to effectively work in a matrix and cross-functional global environment.
  • Champions site/network initiated projects. Justifies goals to senior management.
  • Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product and operations views.
  • Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to Roche.
  • Consistently demonstrates courage and drive to ensure optimal business results.
  • Strong people leadership skills with demonstrated commitment to the Roche leadership principles.
  • Excellent organizational skills with strategic thinking and vision for the group
  • Demonstrated ability to drive for results and lead innovation and change.
  • Demonstrated success in business process development, collaboration and change management.
  • Self-driven, able to prioritize, and to orchestrate multiple activities at once.
  • Consistently demonstrate sound business judgment when making decisions.
  • Ability to deal with ambiguity and complexity and  influence others across levels of the organization
  • Ability to travel 20-30% of time

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.

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.

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