Director Tech Services- Biologics Technical Ops
We want the revolutionaries, the committed collaborators, the bold challengers, the I-can-do-it-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
The Director, Tech Services in the Biologics Technical Operations (BTO) group will have sole accountability for Upstream and Downstream BTO. In this role you will be responsible for both upstream and downstream tech transfers and manufacturing support activities for all internal and external drug substance manufacturing sites and drive business process improvements related to tech transfer, operational support and technical oversight of manufacturing.
Essential Duties and Job Functions:
- Leads the Upstream and Downstream Biologics Technical Operations (BTO) group that is responsible for both Upstream and Downstream technology transfer and manufacturing support activities for all internal and external manufacturing sites
- Defines strategies for consistent and phase-appropriate oversight of Drug Substance (DS) process transfer and manufacturing
- Drives business process improvements related to tech transfer, operational support and technical oversight of manufacturing
- Directs activities of the technical operations group including defining, planning and implementing projects related to scale-up, technology transfer, facility fit and/or process validation between sites
- Directs the development of technical projects and initiatives, determines metrics for success and evaluates performance against metrics
- Partners with Gilead’s Biologics Quality, Process Development and Outsourced Manufacturing groups to ensure project timelines, deliverables, and business operations are aligned and met
- Focuses on strategic planning and execution while managing within the budget
- Supports regulatory inspections and authoring of relevant sections of IND, BLA and MAA filings
- Ensures compliance to safety, business policies, laws and regulations applicable to the operations
- Routine travel may be required in support of technology transfers and manufacturing oversight of CMOs
Knowledge, Experience and Skills:
- 10+ years of experience in the pharmaceutical industry and a BS or BA.
- 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- In-depth knowledge of manufacturing principles and concepts and industry best practices and trends
- Significant experience with upstream and downstream bioprocessing equipment and operations from thaw through harvest through protein purification and drug substance fill
- Strong knowledge of cGMP requirements for clinical and commercial manufacturing
- Broad experience across areas such as manufacturing and development
- Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections
- Demonstrated success as a people manager
- Vaccine and ADC process and regulatory experience is desired
- Prior experience in MSAT, PD and Manufacturing is preferred
We offer a competitive salary and benefits package. Apply today at Director Tech Services- Biologics Technical Ops (myworkdayjobs.com)