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. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Role and Responsibilities:
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
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/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.