Senior Research Scientist I, Purification Process Development – Pivotal & Commercial Biologics

Description

The Senior Research Scientist I, Purification Process Development (Pivotal and Commercial) will be responsible for leading all 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.

He / she will also lead projects for purification process technology development, platform process evolution, and related regulatory documentation.

Key Responsibilities :

• Hands-on technical leadership for the development, characterization, tech transfer and GMP manufacturing support of pivotal and commercial biologic purification processes.
• Manage and mentor research associates and members of project teams in the initiation and execution of laboratory experimentation, considering appropriate safety, economic and regulatory factors.
• Evaluate external service providers and oversee development activities.
• Ensure high-quality documentation in electronic laboratory notebooks and reports.
• Author, review, and approve development reports, process descriptions, batch records, regulatory filings, and process validation and characterization reports.

The candidate must demonstrate excellent verbal and technical writing skills.

• Represent the Pivotal and Commercial Purification Development Department on product development / CMC teams.
• Lead and / or participate on cross-functional initiatives.
• Support investigations and identify root causes for critical deviations.
• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
• Contribute to business process improvements related to pivotal / commercial process development.

Qualifications / Skills / Experience :

• Ph.D. with 2+ years OR M.S. with 8+ years OR 10+ Years with BS experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation / removal is required.
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Antibody drug conjugate experience is a plus.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is desired.
• Demonstrated ability to collaborate and influence cross-functionally.
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
• Working knowledge of lab automation, data management, data science, knowledge management and data protection.
• Passion for inclusion : knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he / she works.

The salary range for this position is : $177,905.00 - $230,230.00. 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.

For jobs in the United States :

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.