Gilead Sciences, Inc.
Scientist, Purification Process Development - Pivotal & Commercial Biologics
Gilead Sciences, Inc., Foster City, California, United States, 94420
Scientist, Purification Process Development – Pivotal & Commercial Biologics
United States – California – Foster City (Process/Product Development & Operations, Regular)
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life‑threatening illnesses worldwide. As a
Scientist, Purification Process Development – Pivotal and Commercial Biologics , you will lead and execute aspects of purification development, including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. You will also support projects for purification technology development, platform process evolution, and regulatory filings.
Key Responsibilities
Demonstrate hands‑on technical leadership of all aspects of purification process development including chromatography, TFF, and depth filtration.
Lead design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.
Responsible for technology transfer to manufacturing facility and provide technical input and support during manufacturing of drug substances.
Author or review GMP or non‑GMP technical documentation (development reports, process description, batch records, etc.).
Author and review CMC‑related regulatory sections.
Demonstrate technical proficiency and scientific creativity in improving platform technology.
Communicate ideas, project strategies and results to team members across functional roles/departments.
Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
Help establish and maintain a state‑of‑the‑art purification lab.
Participate in cross‑functional initiatives as needed.
Adhere to department budget and all training, compliance, and safety requirements.
Basic Qualifications
Ph.D. and 0–2 years of experience in a relevant scientific discipline (biochemistry, bioengineering, chemical engineering, chemistry, etc.).
M.S. with 4+ years or B.S. with 6+ years of experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
Preferred Qualifications
Hands‑on experience of protein purification, thorough understanding of chromatography and familiarity with AKTA.
Broad understanding of downstream development and scale‑up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal.
Experience in pivotal‑stage purification process development, characterization, and implementation in GMP facilities.
Working knowledge of lab automation, high‑throughput screening, and mechanistic modeling.
Demonstrated ability to collaborate and influence cross‑functionally.
Experience in statistics, design‑of‑experiments, and data analysis (e.g., JMP, Spotfire).
Excellent communication skills and strong interpersonal skills.
Motivated self‑starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.
People Leader Accountabilities
Create Inclusion – know the business value of diverse teams, model inclusion, and embed the value of diversity in the way teams are managed.
Develop Talent – understand the skills, experience, aspirations and potential of employees and coach them on current performance and future potential; ensure employees receive the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams – connect the team to the organization by aligning goals, purpose and organizational objectives, and holding them accountable; provide the support needed to remove barriers and connect them to the broader ecosystem.
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Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life‑threatening illnesses worldwide. As a
Scientist, Purification Process Development – Pivotal and Commercial Biologics , you will lead and execute aspects of purification development, including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. You will also support projects for purification technology development, platform process evolution, and regulatory filings.
Key Responsibilities
Demonstrate hands‑on technical leadership of all aspects of purification process development including chromatography, TFF, and depth filtration.
Lead design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.
Responsible for technology transfer to manufacturing facility and provide technical input and support during manufacturing of drug substances.
Author or review GMP or non‑GMP technical documentation (development reports, process description, batch records, etc.).
Author and review CMC‑related regulatory sections.
Demonstrate technical proficiency and scientific creativity in improving platform technology.
Communicate ideas, project strategies and results to team members across functional roles/departments.
Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
Help establish and maintain a state‑of‑the‑art purification lab.
Participate in cross‑functional initiatives as needed.
Adhere to department budget and all training, compliance, and safety requirements.
Basic Qualifications
Ph.D. and 0–2 years of experience in a relevant scientific discipline (biochemistry, bioengineering, chemical engineering, chemistry, etc.).
M.S. with 4+ years or B.S. with 6+ years of experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
Preferred Qualifications
Hands‑on experience of protein purification, thorough understanding of chromatography and familiarity with AKTA.
Broad understanding of downstream development and scale‑up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal.
Experience in pivotal‑stage purification process development, characterization, and implementation in GMP facilities.
Working knowledge of lab automation, high‑throughput screening, and mechanistic modeling.
Demonstrated ability to collaborate and influence cross‑functionally.
Experience in statistics, design‑of‑experiments, and data analysis (e.g., JMP, Spotfire).
Excellent communication skills and strong interpersonal skills.
Motivated self‑starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.
People Leader Accountabilities
Create Inclusion – know the business value of diverse teams, model inclusion, and embed the value of diversity in the way teams are managed.
Develop Talent – understand the skills, experience, aspirations and potential of employees and coach them on current performance and future potential; ensure employees receive the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams – connect the team to the organization by aligning goals, purpose and organizational objectives, and holding them accountable; provide the support needed to remove barriers and connect them to the broader ecosystem.
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