- Entry level
- No Education
- Salary to negotiate
- South San Francisco
Function: External Manufacturing
Platform: Drug Substance
Reports To: Head, Drug Substance External Manufacturing
Main Purpose of the Position:
The Sr Principal Operations Site Manager is responsible for leading a cross functional Site Management Team (e.g., Quality, Supply Chain, Technology) in the CMO life cycle (i.e. Selection, Process Technology Transfer, Commercial cGMP Manufacturing and Decommissioning) at one or more Drug Substance Contract Manufacturing Organizations (CMOs).
He/She acts as the Joint Management Team Lead (JMTL) and will lead the coordination between various departments (e.g., QC, Regulatory, Technical Product Teams) to ensure that all product/project needs are defined and met. This includes developing a CMO strategy, negotiating contracts, managing the business relationship, ensuring the successful CMO supply of product, and achieving operational and business goals. He/She will lead a project portfolio, process changes, investigations, process improvements and risk mitigations.
Drives the application of CMO strategies and determines the best course of action for decisions related to the CMO life cycle. Influences the development of overall objectives and long-range goals of the Drug Substance Manufacturing Unit and supports strategy realization through leading global goals, projects and/or initiatives. Serves as a consultant to management (e.g., Product Review Committee) on matters pertaining to its policies, plans, objectives and business operations. Acts as the deputy to the Head of Drug Substance External Manufacturing.
Participates and contributes in CMO selections (e.g., define evaluation criteria) and evaluates a CMO’s capacity and capability (e.g., on site due diligence) as an input to a sourcing decision. Influences and supports the decision making process.
Develops, negotiates and administers commercial supply and quality agreements. Forecasts CMO budget and gains approval. Controls cost to ensure the CMO Site is within the approved budget.
Leads product launches and technology transfers (new/existing products & facilities) including planning, qualification, and achieving regulatory licensure for Roche’s product at a CMO’s manufacturing facility. Develops an in depth knowledge of the CMO manufacturing process and systems. Leads decommissioning of a CMO following either termination or expiration of an agreement.
Executes with the CMO the production plan (e.g., forecast, capacity, raw material inventory) to deliver an uninterrupted supply of commercial product. Identifies supply constraints and leads timely resolution of issues (e.g., discrepancies). Monitors production campaigns and reports on CMO’s performance against plans, including negotiation of improvement plans for adverse trend performance.
Facilitates the identification, prioritization, planning and execution of a broad range of medium to complex technical projects. Ensures successful and timely completion of deliverables. Owns planning and execution of technical changes that have regulatory and/or multi-site impact.
Ensures that corporate safety, health and environment (SHE) and Quality audits are performed and mitigations plans are in place for the CMO to comply with terms of agreements, corporate group policy and local legal requirements.
Qualifications: Knowledge & Skills
The ideal candidate will have the following skills:
Cross Functional Team Management - Proven success in operating within a matrix organization and ability to manage multiple organizational interfaces and geographically dispersed team members. Demonstrates interpersonal skills to bring people together of diverse backgrounds and skill-sets to meet goals, execute projects, solve problems, and implement improvements without direct authority.
Decision Making - Leads cross functional teams in the decision making process including framing the decision (e.g., identify decision maker, stakeholder input), making the decision (e.g., use of data, stakeholder communication) and learning from the outcome (e.g., sharing best practices, applying to future work). Ensures that decisions and solutions are aligned with organizational objectives.
GMP/Regulations - Working knowledge of cGMP regulations and standards to assess the health of the CMO operations, interpret SOPs to regulations and provide solutions for complex Quality
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.