Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development

Description

The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) will be responsible for leading aspects of cell culture development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I / II).

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

Key Responsibilities :

• Lead cell culture process development and implementation in internal and external GMP facilities, as well as technical support of GMP operations.
• Establish and maintain a state-of-the-art cell culture process development laboratory.
• Lead cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
• Design and conduct laboratory scale experiments; hands-on laboratory execution is expected.
• Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
• Ensure high-quality documentation in electronic laboratory notebooks and reports.
• Author relevant sections of regulatory filings and responses to information requests.
• 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 early-stage process development.
• Adhere to department budget and all training, compliance and safety requirements.
• Mentor junior team members on cell culture process development strategies and experimental design and execution.
• Participate on cross-functional initiatives.

Qualifications / Skills / Experience :

Ph.D. with 2+ years OR M.S. with 8+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering) OR B.

S. with 10+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering)

• Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.
• Experience in pre-pivotal stage cell culture process development and implementation in GMP facilities.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• Demonstrated ability to collaborate and influence cross-functionally.
• Experience in cell culture media development, and / or model development for upstream process development and optimization is preferred.
• 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.
• Experience with viral vaccines is a plus.
• 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.