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Director, Biologics Pivotal Formulation & Process Development

United States - California - Foster CityProcess/Product Development & OperationsRegular
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Job Description

The Director, Biologics Pivotal Formulation and Process Development will be responsible for leading pivotal and commercial drug product process development and enabling successful pivotal and commercial regulatory filings for biologics in multiple therapeutical areas. This role is also expected to work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies.

Responsibilities:

  • Establish and maintain a state-of-the-art lab that can enable drug product process development for liquid and lyophilized dosage forms.

  • Establish pivotal and commercial fill and finish workflow that would meet cGMP requirements.

  • Ensure scalability of DP process and successful technical transfers to in-house or external GMP manufacturing facilities; oversee GMP manufacturing master batch record generation and support manufacturing investigations.

  • Drive technical innovation and encourage scientific investigations; influence internally and externally through publication and presentations; lead by example.

  • Establish documentation templates and review/approve technical documentations from internal team or contracted organization; oversee data generation, data integrity, and ensure compliance and excellence from internal and contract organizations.

  • Hire, mentor, and develop a team of scientists with a focus on technical excellence as well as teamwork and collaboration across all PDM organizations; grow employees as formulation and drug product leads for pivotal biologics programs

  • Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/BLA; 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 inputs.

Qualifications:

  • BA in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with 12+ years of industrial experience OR

  • MS in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with 10+ years of industrial experience OR

  • Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with 8+ years of industrial experience

  • Biologics CMC development experience with people leader accountabilities required.

  • Extensive experience with late stage formulation development and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats.

  • Extensive experience with drug product fill and finish process development; process validation and GMP manufacturing support of liquid and lyophilized products, and prefilled syringe; experience of IND and BLA submissions.

  • 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 in leading teams and growing talents.

  • Strategic thinker with business acumen.

*Preferred Qualifications:

  • Advanced degree in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related field(s)

  • Experience working with CDMOs 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)