Senior Scientist, Process Development

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Job Description

The Senior Scientist Purification Process Development & Technology Transfer will provide scientific and technical leadership for the development scale-up characterization technology transfer and manufacturing implementation of biologics drug substance purification processes.

This role spans the purification process from harvest through bulk drug substance including harvest clarification chromatography virus inactivation virus filtration ultrafiltration/diafiltration formulation and drug substance final filtration. The successful candidate will combine strong hands-on purification expertise with demonstrated experience transferring drug substance processes to internal manufacturing sites and external partners or contract development and manufacturing organizations and supporting GMP manufacturing execution.

Key Responsibilities

• Serve as the purification technical lead for assigned pivotal and commercial programs providing scientific direction identifying technical risks and communicating recommendations trade-offs and mitigation strategies to project and functional teams.

• Lead drug substance technology-transfer workstreams to internal manufacturing sites and external partners or contract development and manufacturing organizations including process scale-up facility fit manufacturing readiness and transfer execution.

• Lead the development optimization scale-up and characterization of robust scalable and manufacturable biologics purification processes.

• Provide hands-on technical leadership across harvest clarification chromatography virus inactivation virus filtration other filtration operations ultrafiltration/diafiltration formulation and final filtration.

• Design execute and interpret process characterization and scale-down studies using appropriate scientific and statistical approaches including Design of Experiments.

• Establish scientifically justified operating ranges and contribute to the development of integrated process control strategies.

• Develop project plans coordinate technical activities manage risks and deliver purification work products in alignment with program objectives and timelines.

• Provide technical support during engineering clinical process performance qualification and other GMP manufacturing campaigns including on-site and person-in-plant support as needed.

• Lead or support troubleshooting deviation investigations root-cause assessments and technical investigations related to process performance and GMP manufacturing.

• Author and review development reports study protocols process descriptions technology-transfer documentation standard operating procedures manufacturing batch records and CMC regulatory content.

• Collaborate across Process Development Manufacturing and MSAT Analytical Development Formulation Development Quality Regulatory Affairs Supply Chain and other CMC functions.

• Mentor junior scientists and contribute to the advancement of purification technologies platform processes and organizational best practices.

• Travel as needed to support technology transfers and provide technical oversight at internal and external manufacturing facilities.

Basic Qualifications

• PhD in Chemical Engineering Biochemical Engineering Bioengineering Biochemistry or a related scientific discipline with 2 or more years of relevant experience;

• MS in a relevant scientific or engineering discipline with 6 or more years of relevant experience; or

• BS in a relevant scientific or engineering discipline with 8 or more years of relevant experience.

Preferred Qualifications

• Experience in biologics purification process development characterization scale-up and GMP manufacturing implementation.

• Demonstrated experience leading drug substance technology transfers to internal manufacturing sites external partners or contract development and manufacturing organizations.

• Broad technical expertise in harvest clarification chromatography virus inactivation virus filtration ultrafiltration/diafiltration formulation and final filtration.

• Experience supporting engineering clinical process performance qualification and commercial manufacturing campaigns including batch-record review and on-site or person-in-plant support.

• Experience establishing and qualifying scale-down models and applying Design of Experiments and statistical analysis to define operating ranges and characterize process performance.

• Experience developing process control strategies and supporting process validation readiness.

• Experience authoring or contributing to CMC regulatory filings and responses to health authority questions.

• Demonstrated ability to identify and resolve complex technical risks using sound scientific judgment.

• Strong technical writing communication cross-functional collaboration and project leadership skills.

The salary range for this position is: $169320.00 - $219120.00. 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.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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.

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