Vice President – Analytical Development
| Company | Gilead Sciences |
|---|---|
| Location | San Mateo, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Typically requires a PhD, MS, or BS in chemistry or related fields with 20+ years of relevant experience
- Must have CMC experience with a range of modalities, including small molecules, peptides, ADCs, and biologics – with 15+ years of relevant experience in biologics preferred
- Recognized as leader in the field of Analytical Development with extensive external experience with relevant multi-national scientific organizations, conferences, associations, and health authorities
- Sound knowledge of chemistry, analytical technologies, computerized systems, and data integrity
- Well-versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance, drug product, and devices
- Well-versed in analytical control strategies
- Experience with analytical testing networks
- Strong business acumen, including business contracting expertise
- Working knowledge of lab automation, computer validation, data governance, data science, knowledge management, and data protection
- Proven ability to lead high performing teams
- Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, and strategic vision
Responsibilities
- Provide leadership and direction to the Analytical Development organization, a department of 200+ scientists
- Set strategies and develop long-range plans for all modalities in line with Gilead strategic priorities to deliver on Gilead’s long-term ambitions
- Provide technical guidance and drive alignment of near-term deliverables and long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product quality attributes across all PDM (Pharmaceutical Development & Manufacturing) functions
- Oversee analytical method development and analytical characterization for all drug substances and drug products in R&D programs
- Oversee data generation / data integrity
- Lead analytical team leads for Gilead Development Team and Commercial PDM sub-teams
- Direct AD leads for all PDM project teams and all commercial project teams
- Serve as a key advisor for the review of relevant PDM project reviews
- Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing PDM development strategies
- Evaluate and implement new technologies to drive innovation in Analytical Development and testing
- Drive development and implementation of new systems to improve project execution and data management
- Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Regulatory Affairs, Manufacturing and Technical Operations, Product and Portfolio Management, Finance, and Supply Chain
- Ensure strong relationships with key stakeholder functions including Research, Clinical Development, Clinical Supply Management, and Program Strategy Teams by providing technical and strategic input as a key advisor
- Hire, mentor, and develop team members within the organization
- Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections
- Provide technical support to internal and external cGMP manufacturing operations
- Develop and manage department budget
Preferred Qualifications
- 15+ years of relevant experience in biologics preferred