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The Clinical Manufacturing Science & Technology (MSAT) Senior Manager is an integral member of the Clinical Supply Center (CSC) team in South San Francisco (SSF). The SSF CSC is a state-of-the-art large molecule drug substance facility that supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC employs a ballroom design, utilizes single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility.  We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.  Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.  Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. 

The Opportunity

In this role, the qualified individual will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.  The candidate will be a member of the extended Drug Substance Leadership Team and will lead teams and projects, coach individuals across the entire organization and lead by example through their own behaviors. 

The Clinical MSAT Senior Manager of Operations, Process Support and Process Engineering (OPP) will report to the Head of OPP. The Senior Manager will play a critical role in leading and coordinating technology transfer activities for molecules into receiving manufacturing sites within the Clinical Supply Center (CSC). This includes managing the end-to-end transfer process, ensuring seamless execution of processes, and guaranteeing compliance with regulatory and company standards. The role involves developing and implementing strategies to enhance the efficiency and success of tech transfer initiatives while fostering cross-functional collaboration. The incumbent will also maintain operational compliance, support regulatory filings and inspections, and drive continuous improvement efforts across the organization.

The ideal candidate demonstrates strong technical expertise, project leadership, and an innovative mindset to optimize technology transfer processes while reducing lead times and resource requirements. Additionally, this role requires leveraging organizational partnerships to ensure strategic alignment and excellence in all aspects of tech transfer and compliance
 

Job Responsibilities Include:

Tech Transfer Leadership

• Lead and coordinate end-to-end technology transfer activities for molecules into receiving manufacturing sites, including the development and execution of detailed transfer plans for change records, New Product Introduction requirements, risk assessments, gap analysis, recipes, and master batch records.

• Drive standardization and streamline tech transfer workflows to improve efficiency, scalability, and successful project completion.

Regulatory and Quality Oversight

• Author and review regulatory filings and documents related to technology transfer and product introduction, providing strategic guidance to ensure full compliance with regulatory expectations and readiness for regulatory inspections.

• Oversee the management and timely closure of Corrective and Preventive Actions (CAPAs) and Planned Events (PEs), ensuring systematic verification of effectiveness.

• Oversee Quarterly Quality Incidents (QI) adverse trending reports, driving robust analysis and actionable remediation strategies to address systemic issues.

Cross-Functional Collaboration and Leadership

• Lead and mentor cross-functional teams to achieve project and organizational objectives for tech transfer activities.

• Cultivate effective partnerships within the CSC and across Roche functions to ensure operational consistency and strategic alignment. 

Strategic Improvement and Innovation

• Propose and implement strategic technology and process improvements to optimize t