Associate Scientist - Upstream

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 75,000 - 115,000; Full time

Job summary

Join a forward-thinking biopharmaceutical company as an Associate Scientist focused on upstream drug substance processing. This pivotal role involves supporting technology transfer activities and ensuring compliance with GMP standards. You will collaborate with diverse teams to address complex challenges in biologics manufacturing, contributing to innovative solutions that enhance patient care. If you are a motivated team player with a passion for scientific innovation and a desire to make a difference, this opportunity offers a rewarding career path in a dynamic environment dedicated to improving lives.

Qualifications

• Degree in Chemical Engineering, Bioengineering, or related field.
• 2+ years experience with MS or 4+ years with BS in relevant field.

Responsibilities

• Support technology transfer and validation of biologics manufacturing processes.
• Collaborate with cross-functional teams for investigations and documentation.
• Ensure compliance with GMP quality change management procedures.

Skills

Upstream Biologics Drug Substance Manufacturing

Troubleshooting Skills

Collaboration Skills

GMP Knowledge

Technical Documentation Review

Education

MS in Chemical Engineering

BS in Bioengineering

BS in Pharmaceutical Sciences

Job description

Associate Scientist - Upstream

Location: United States - California - Foster City

Department: Process/Product Development & Operations

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. We deliver life-saving therapies to patients worldwide. Join us to be part of a team that is changing lives and helping millions live healthier, more fulfilling lives. Our community is dedicated to scientific innovation, with marketed products benefiting hundreds of thousands, a pipeline of late-stage drug candidates, and patient access programs to ensure medication affordability. By joining Gilead, you contribute to addressing unmet medical needs and improving patient care worldwide.

The Associate Scientist role focuses on commercial technology transfer. We seek motivated, team-oriented individuals with experience in biopharmaceutical upstream drug substance processing. Responsibilities include supporting technology transfer activities such as facility fit & gap assessments, capital improvements, risk assessments, process validation, and working with Contract Manufacturing Organizations to establish commercial manufacturing processes. The role involves implementing continuous process verification and providing technical support during manufacturing and quality investigations.

Job Responsibilities

1. Participate in Global Biologics Manufacturing Sciences & Technology (MSAT) project teams supporting technology transfer and validation of biologics manufacturing processes.
2. Contribute to project workstreams including facility fit, risk assessments, control strategy development, validation strategy, and change management. Author related reports.
3. Ensure GMP quality change management procedures are followed to facilitate timely technology transfer. Collaborate with process development, quality, and regulatory teams during investigations of OOS, OOT, and deviations.
4. Support process characterization activities and establish design space for commercial tech transfer and validation. Assist with experimental design and result review.
5. Review technical documentation such as protocols, master batch records, and reports for engineering runs, GMP, and PPQ campaigns.
6. Contribute to process validation sections of regulatory filings to support product launch and expansion.
7. Support ongoing commercial production through GMP change management, manufacturing support, and deviation investigations.
8. Travel up to 20% to support activities.

Qualifications

• Degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or related field. MS with 2+ years or BS with 4+ years of relevant experience.
• Understanding of upstream biologics drug substance manufacturing, e.g., mammalian cell culture, bioreactors, harvest/recovery.
• Experience supporting biologics manufacturing operations, technology transfer, or development.
• Knowledge of GMPs and regulatory requirements is preferred.
• Strong troubleshooting skills and ability to resolve complex technical issues.
• Effective collaboration skills in a dynamic, cross-functional environment.
• Excellent verbal and written communication skills.

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Job Requisition ID R0044724

Full Time

Job Level: Associate

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