DS Global Head Process Validation, Tech Transfer, and Launch

Company: Genentech
Location: San Francisco
Posted on: March 10, 2025

Job Description:

The PositionAs part of Pharma Technical Development (PTD), our organization is committed to delivering the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative, and effective drugs using cutting-edge technologies for manufacturing processes (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development.Together with our partners, Global Biologics Bioprocess Development develops robust, efficient, and sustainable bioprocesses including Cell Line & Media Development, Cell Culture & Fermentation, and Purification Development.The OpportunityThe Head of Process Validation, Tech Transfer & Launch is responsible for overseeing the strategic alignment, management, and execution of technology transfer (TT), process validation (PV), and launch activities across Roche's global network. This role ensures the seamless transition of new processes from development to commercial manufacturing while upholding the highest standards of safety, compliance, and operational efficiency.In this leadership position, the Head of Process Validation, Tech Transfer & Launch will drive the integration and alignment of technology transfer and process validation activities, working closely with commercial sites and cross-functional teams to ensure the successful launch of new products.Primary responsibilities and accountabilities:

• Lead Tech Transfer, Process Validation, and Launch Activities: Oversee and coordinate cross-functional teams involved in the execution of TT, PV, and launch efforts, ensuring alignment across the organization and a smooth transition to commercial manufacturing.
• Strategic Leadership and Alignment: Drive alignment of TT and PV activities within Roche's global network, ensuring consistency in product and systems ownership (e.g., Basecamp2.0). Lead and support efforts to align strategies with commercial sites.
• Regulatory and Quality Oversight: Author, review, and approve critical documents, such as method validation protocols, reports, and regulatory submissions. Provide expertise in responding to Q&A from health authorities and ensuring all processes meet global regulatory standards.
• Collaboration and Innovation: Foster collaborations with internal teams and external partners to ensure that TT, PV, and launch activities are effectively implemented across the network, driving efficiency and reliability.
• Drive Problem Solving and Innovation: Anticipate and address challenges in technology transfer and process validation, applying innovative thinking to solve problems and improve outcomes. Lead initiatives that enhance the alignment of late-stage development with commercial needs.Who you areEducation/Qualifications
  • Ph.D. degree in Biotechnology, Chemical Engineering, or a Life Science related discipline. MBA is also an advantage.
  • 15+ years of experience in the bio-pharmaceutical industry, i.e., biologics manufacturing, development or related CMC functions, with at least 10 years of senior managerial experience.Experience, Skills and Knowledge
    • 15+ years of experience in the biopharmaceutical industry, with a strong background in process validation, technology transfer, and product launch.
    • Proven track record of managing tech transfer and late-stage process development functions within a GMP-regulated environment.
    • Extensive experience in product development, validation, and commercialization is a plus.
    • Strong expertise in regulatory requirements, including experience authoring and reviewing documents for regulatory submissions.
    • Working knowledge of cGMP and process validation protocols, with the ability to manage complex projects in a global network.
    • Exceptional leadership skills, with the ability to drive strategic initiatives and align cross-functional teams across different sites and geographies.Values, Leadership and Competencies
      • Strategic Leadership: Demonstrated ability to lead global, multi-disciplinary projects focused on TT, PV, and product launch, ensuring seamless alignment across the network.
      • Collaboration: Strong track record of building strategic collaborations both internally and externally to drive success in biopharmaceutical manufacturing.
      • Business Acumen: Proactive in identifying business and operational challenges, offering solutions that align with Roche's long-term strategic objectives.
      • Communication and Interpersonal Skills: Proficient in English, with excellent communication and team management abilities. Proficiency in German is an advantage.Other (e.g. Travel)
        • National and international travel: up to 20%.Your application: Please upload your current resume and/or apply with your updated Workday profile.Relocation benefits are not available for this job posting.The expected salary range for this position based on the primary location of South San Francisco, CA is $202,100 to $375,300. 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.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.
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Keywords: Genentech, San Francisco , DS Global Head Process Validation, Tech Transfer, and Launch, Other , San Francisco, California