Site Manager External Manufacturing

Roche•South San Francisco, CA

19h

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position The External Manufacturing Organization (CDMO), in conjunction with Internal Manufacturing Network, runs the development and manufacturing of starting materials, intermediates, drug substance, drug product, devices, delivery systems and packaging of synthetic and biological products at external partners in Europe, North America and in ROW or in an out-licensing set up. The Site Manager External Manufacturing acts as the primary contact and relationship manager to specified partner(s)/site(s)) for the entire relationship. The core business is to handle multiple partners with low/medium/high complexity within one or cross material groups (DS/DP/FINP/Device)/cross chapters/cross partner sites and multiple and/or special technologies depend on experience. The Site Manager External Manufacturing will on request act as mentor for managing partners. Additionally, she/he manages multiple simple/complex Tech transfers (project management) OR simple/complex multiple cross PTSX/PTS projects also over longer periods if necessary or Lead/Support Due diligence/Sourcing projects as required and manages relationships beyond PTS/PT. He/she could also lead complex E2E squads. In case of development focus the Site Manager External Manufacturing handles multiple low/medium/high complexity CMC projects across technologies (SM and LM)/Life Cycle (Development to commercial) depending on experience. She/he acts as the primary contact and relationship manager to specified partner(s/site(s)) for a specific molecule. Furthermore she/he leads or participates in cross PTSX/PTS projects OR Lead/Support DD/Sourcing projects as required. The Opportunity: You act as the primary lead and relationship manager for CDMOs throughout the entire product Lifecycle, from initial selection and implementation to decommissioning. Furthermore: Cross-Functional Leadership: Leads international governance teams (JMT, JPT, JSC) across diverse functions such as Quality, MSAT, Legal, and Procurement to ensure organizational alignment. Supply Chain Accountability: Ensures the seamless execution of development, preclinical, clinical, and commercial supply, including leading product transfers and launches. Operational Oversight: Manages routine production, QC activities, and partner performance to ensure high-quality manufacturing solutions and patient access. Compliance & Risk Mitigation: Enforces strict adherence to GMP, Quality, and SHE standards while conducting regular risk reviews to proactively address potential supply issues. Financial Stewardship: Utilizes business acumen and COGs (Cost of Goods) expertise to manage budgets, partner with procurement on negotiations, and drive cost-reduction initiatives. Strategic & Agile Execution: Aligns partner activities with Roche’s global manufacturing strategy while maintaining the agility to work across different squads and matrix teams as needed. Who you are: We have high expectations around end-to-end thinking and cross functional collaboration in a global network by taking ownership and delegating decisions to the appropriate level. We value an entrepreneurial mindset with the ability to constantly change or adapt in a dynamic environment. We expect you to focus on the most impactful and value adding work by prioritizing your efforts with a clear focus on creating value for the patient. You will be willing to explore new opportunities, be comfortable with ambiguity and taking smart risks, while complying with the latest regulations.

Requirements

Extensive Industry Experience: At least 10 years in manufacturing/operations, with a minimum of 5 years specifically managing large-scale, complex cross-functional projects or units.
Educational Background: A Bachelor’s degree in Engineering or Life Sciences is required, though an advanced degree (MBA, MS, or PhD) is preferred.
Technical GMP Expertise: Proficiency in a GMP-regulated environment, specifically regarding drug substance (DS) and drug product (DP) development, with a preference for Small Molecules, Peptides, or Oligos.
Leadership and Team Management: Proven ability to lead direct reports or matrixed cross-functional teams for 3+ years, demonstrating strong collaboration and communication across all hierarchy levels.
Business and Strategic Acumen: Strong negotiation skills and the ability to interpret complex data to drive informed business decisions and manage project risks beyond technical aspects.
Integrity and Compliance: A commitment to operating with high integrity, ensuring business partners adhere to the corporate Code of Conduct and compliance standards.
Communication and Mobility: Excellent English communication and presentation skills, with the flexibility to undertake up to 25% domestic and international travel

Responsibilities

Act as the primary lead and relationship manager for CDMOs throughout the entire product Lifecycle, from initial selection and implementation to decommissioning.
Lead international governance teams (JMT, JPT, JSC) across diverse functions such as Quality, MSAT, Legal, and Procurement to ensure organizational alignment.
Ensure the seamless execution of development, preclinical, clinical, and commercial supply, including leading product transfers and launches.
Manage routine production, QC activities, and partner performance to ensure high-quality manufacturing solutions and patient access.
Enforce strict adherence to GMP, Quality, and SHE standards while conducting regular risk reviews to proactively address potential supply issues.
Utilize business acumen and COGs (Cost of Goods) expertise to manage budgets, partner with procurement on negotiations, and drive cost-reduction initiatives.
Align partner activities with Roche’s global manufacturing strategy while maintaining the agility to work across different squads and matrix teams as needed.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume