The Director, Formulation and Proess Development for Pre-pivotal Biologics will be responsible for leading first-in-human formulation and drug product process development strategies and enable successful pre-pivotal regulatory filings for biologics in multiple therapeutical areas. This role will also work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies.
Responsibilities:
- Lead a sub-organization with team leads and scientists; develop a team with focuses on technical excellence, teamwork, and cross-functioanl collaborations; grow employees as formulation scientists and drug product leads for pre-pivotal biologics programs
- Establish and maintain state-of-the-art labs that can enable a full spectrum of in-house capability of stability evaluation, biophysical characterizion, process development, and clinical in-use evaluation; capable of setting up new labs
- Enhance formulation development workflows for platform molecules and complex biologics that can enable fast-to-clinical timelines and achieve phase-appropriate understanding of molecular properties.
- Drive technical innovation and encourage scientific investigations; influence internally and externally through publication and presentations; lead by example.
- Ensure high quality of work; oversee data generation, data integrity, and ensure compliance and excellence from internal and contract organizations.
- Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections.
- Set strategies and develop long-range plans in line with Gilead strategic priorities to deliver on Gilead’s long-term ambitions.
- Ensure strong relationships with key stakeholder functions including Analytical Development, Cell Culture, Purification, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic input.
Basic Qualifications:
- Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry with 8+ years of industry expereince in biologics CMC development with people leader accountabilities.
OR
- M.S. in Pharmaceutical Science, Chemistry, Biochemistry with 10+ years industrial expereince in biologics CMC development with people leader accountabilities.
OR
- B.S. in Pharmaceutical Science, Chemistry, Biochemistry with 12+ years of industrial experience in biologics CMC development with people leader accountabilities.
Preferred Qualifications:
- Extensive experience with formulation development, drug product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats, in a wide concentration range from ultra low to high; extensive experience of IND filings.
- Experience with GMP manufacturing of biologics drug product.
- Well versed in FDA, EMA, and ICH guidelines and GLP/GMP requirements relating to drug product development.
- Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
- Established people leader with experience leading teams and growing talents.
- Strategic thinker with business acumen.
- Late-stage/pivotal phase development experience and leadership, and BLA filing experience is highly desired.
- Experience working with contracted organization is highly preferred.
- Experience in leading digital transformation and/or lab automation is highly preferred.
Gilead Core Values
- Integrity (Doing What’s Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
The salary range for this position is: $226,185.00 – $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
