Principal Site Manager/Sr. Principal Site Manager, Contract MFG
Join a Team that Lives to Improve Lives
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
Principal Site Manager/Sr. Principal Site Manager, Contract MFG
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.
Who You Are
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 System issues. Experience in interacting with Health Authorities (e.g., inspections) and implementing new requirements.
- Improvement/Problem Solving - Identifies problems/improvements and leads teams in the problem solving/improvement process using a structured methodology (e.g., data driven decisions, identify root cause, effective solution development). Ability to handle complex situations (e.g., cross-site investigations) and navigate through ambiguity (e.g., difficulty obtaining data).
- Leadership - Evaluates a CMOs capacity and capability and develops executable action plans to meet Roche’s Drug Substance network strategy. Ability to interact with and provide senior management with CMO insights and recommendations to enable informed decisions such as CMO selection and decommissioning. Ability to manage change across multiple groups by a developing business cases, soliciting support and influencing stakeholders.
- Employee Development/Mentorship - Manages junior managers and/or contractors on projects or specific site management activities. Provides guidance and coaching to develop their skill-set.
- Project Management - Leads the identification, prioritization, planning and execution of a broad range of medium to complex technical project portfolio. Ensures successful and timely completion of deliverables. Excellent organizational skills and ability to facilitate meetings including documenting meetings, decisions, risks and actions.
- Quality Systems - Working knowledge of GMP Quality Systems (e.g., Trackwise) including discrepancy management and technical change management. This individual must have an engrained Quality mindset demonstrated in all areas of work and appropriately balancing quality, speed and cost in decision making.
- Stakeholder Management/Relationship Management - Establishes and maintains collaborative working relationships with their cross functional Site Management Team, key stakeholders, and internal and external customers. Possesses strong verbal and written communication skills and the ability to influence at all levels.
- Safety, Health & Environment (SHE) - Working knowledge of SHE in Small Molecule Manufacturing is a plus.
- Technical - Working knowledge of the Biologics and/or Small Molecule Drug Substance manufacturing process. Keeps current with industry trends, new technology and process challenges and applies learnings across CMOs and Drug Substance Manufacturing Unit.
Qualifications: Education & Experience
- 12-15 years’ experience (10-13 years with Master’s degree, 7-10 years with PhD) successfully working in an operations environment, with at least 8 years managing large, complex cross functional projects. BS in the relevant Engineering or Life Sciences field discipline is required. An advanced degree (MBA, MS, or PhD) is preferred.
- Experience working with Contract Manufacturers is required with overall knowledge of small molecule and/or biologics Drug Substance commercial manufacturing in a cGMP regulated environment. Previous experience in technology, quality and/or supply chain roles is preferred.
- Certification in Project Management (i.e. PMI certification) or additional relevant management training is preferred.
- Certified/expertise in improvement or problem solving methodologies (Six Sigma, Lean, RCA) is desired.
- This position may require up to 25% domestic and international travel.
A Job with Benefits Beyond the Benefits
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.