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The ATMP Technical Development Leader (TDL) is responsible for leading Technical Development Teams (TDTs) in crafting and driving Chemistry, Manufacturing, and Control (CMC) strategies for ATMP clinical drug candidates from early human trials through product launch. The TDL ensures successful achievement of TDT goals, effective risk mitigation, and seamless communication across teams and cross-functional collaborators. This role involves comprehensive project planning, scheduling, resourcing, and reporting.

Major Duties and Responsibilities

Leadership: Lead scientific and technical teams throughout the product lifecycle, from preclinical development to product launch, ensuring the scientific integrity of the CMC strategy.

Strategy Development & Execution: Develop and implement multifaceted technology strategies essential for product success, including manufacturing processes, drug product configurations, supply chains and regulatory submissions.

Enterprise-wide Perspective: Provide strategic insights and ensure customer focus in project deliverables; Maintain regular updates to project teams, senior management, and governance committees, ensuring transparent decision-making.

Innovation: Design strategies for licensure of new modalities and associated critical and starting materials, building new company capabilities as required.

Representation: Represent Pharma Technical functions on product/lifecycle teams and external partners as needed to align CMC strategy with broader goals of the company.

Project Management: Oversee manufacturing and delivery of clinical supplies, manage CMC development costs, and ensure adherence to timelines, milestones and resource forecasts.   Anticipate and resolve issues, developing contingency and risk mitigation plans.

Decision-Making: Serve as the primary decision-maker for CMC development, investments, and risk management, employing effective decision-making processes.

Working closely with Pharma Technical leaders to ensure CMC strategy is aligned with the broader PT ambitions

As part of the the PTC Cell Therapy Development Leadership team, contribute to improving the department’s scientific reviews, prioritizations and may lead department initiatives

The TDL role demands excellent communication, collaboration, strategic and critical thinking, decision-making, negotiating, and influencing skills, along with the ability to lead complex projects and solve intricate problems.

Required:

B.S./M.S/Ph.D. degree in chemistry, pharmaceutics, biological, chemical engineering or related field

7-15 years of experience in the pharmaceutical industry, with prior experience as a CMC team leader and strong technical knowledge of biologics process development and control system implementation.

Advanced understanding of the drug development process and a history of successful innovation, recognized as a thought leader in CMC/product development.

Advanced knowledge of ATMP CMC development (including Cell Therapy) is a must.

Program Management: Demonstrated ability to handle complex, cross-functional programs and innovate new ideas and approaches.  Ability to work proactively and think strategically.   Strong negotiation and decision-making skills. 

Collaboration: Effective collaborating with team members and senior management. Successful experience working with third parties.

Communication: Excellent verbal and written communication skills, with a history of influencing others in cross-functional areas.

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of South San Francisco, CA is $201,900 to $374,900 annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.