Manager, External Manufacturing- Devices
Manager, External Manufacturing (Devices)
The primary focus of this role is to lead the outsourcing of device development and manufacturing at external device partners, through close collaboration with internal stakeholders within the Device Development and Primary Packaging Engineering (DDCPE) group here at Gilead. This role may also include the management of clinical drug product manufacturing (parenterals, oral solid dosage) at contract manufacturing organizations (CMOs).
Job Duties:
- Serve as business lead and point of contact at external device partners and CMOs
- Effectively negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
- Prepare, review and negotiate request for proposals
- Enter purchase requisitions to Gilead accounting system (Oracle)
- Ensure accurate and on-time payments to Gilead partners
- Lead and/or participate in Operational Excellence projects
- Monitor and verify implementation of Gilead’s controlled documents at CMOs
- Develop budgets and accurately report accruals to Finance
- Lead and/or support business reviews with CMOs or external partners
- Lead teams solving complex problems
- Effectively communicate issues to management and project teams
- Organize and participate in teleconferences and face-to-face meetings with CMOs; work closely with Gilead teams to manage CMO deliverables
- Maintain outsourced project timelines and evaluate progress against established dates
- Lead Business Reviews with CMOs.
- Evaluate and onboard CMOs including site visits, contract negotiating, initiating GMP audits, applicable Work Orders and Purchase Orders
- Maintain oversight of financials and project deliverables associated with outsourced development activities
- Proactively communicate issues, project changes to key stakeholders and facilitates timely discussion and resolution
- Maintains and updates documentation and timelines to accurately reflect the status of the outsourced activities
- Manage outsourcing staff including training, coaching and conducting performance evaluations
Essential Education, Experience and Skills:
- 7 years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; OR MA/MBA degree with 5 years of experience.
- Prior experience with device development and/or combination productions is preferred
- Strong computer skills and experience with an ERP system and project management software
- Strong understanding of activities related to the CMC development
- Knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
- Ability to lead cross functional teams
- Strong people management skills
- Strong negotiation, verbal and written communication skills
- Ability to manage multiple programs/projects; sound organizational and time management skills is essential
- Ability to work under uncertainty and to resolve conflict in a constructive manner
- Ability to solve complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
- Ability to work in a fast-paced environment is essential
- Project management experience and/or certification are a plus
- This position may require up to 20% domestic and international travel
About Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.