Director, Formulation and Process Development for Pre-Pivotal Biologics

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)