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Director, Formulation Development - Pre-pivotal Biologics

Gilead Sciences, Inc.
Foster City, CA
Start date
Feb 24, 2024

View more

Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Biotech Bay, Best Places to Work

Job Details

Director, Formulation Development - Pre-pivotal Biologics
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description

The Director, Formulation Development for Pre-pivotal Biologics will be responsible for leading first-in-human formulation development strategies and enable successful pre-pivotal 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.

  • Establish and maintain a state-of-the-art lab that can enable formulation development work packages for stability evaluation, biophysical characterizion, and clinical in-use evaluation.
  • Collaborate with late-stage research to develop workflows for screening lead molecules with optimal developability.
  • Establish formulation development workflows for platform molecules and complex biologics that can enale fast to first-in-human clinical trial 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.
  • 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 pre-pivotal biologics programs
  • 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.

  • Ph.D. with 8+ years OR M.S. with 10+ years OR BS with 12+ years of experience in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).
  • Extensive experience with formulation development and tox/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; experience of IND and/or BLA filings.
  • Working knowledge of lyophilization cycle development, GMP drug product fill and finish, lab automation, data science, and knowledge management.
  • 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.
  • Experience working with contracted organization 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: $221,170.00 - $286,220.00. 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*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.



Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.



Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

Company info
333 Lakeside Drive
Foster City
United States

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