Senior Associate Scientist, Biologics

Gilead Sciences • Foster City, CA

1d

About The Position

The Senior Associate Scientist, Biologics Pilot Lab Operations leads and executes pilot-scale cell culture operations to generate materials for toxicology studies and Process Development activities. The role is responsible for Pilot Lab operational readiness, staff training, innovation, and technology evaluation in collaboration with process development groups to improve operational capacity, efficiency, and process productivity. The scientist works with cross-functional stakeholders and contributes to successful filings for Gilead’s biologics pipeline.

Requirements

• Bachelor’s degree in Chemical Engineering, Bio-engineering, Biochemical Engineering, Biochemistry, or a related field, with at least 5 years of industrial experience in biologics purification development and/or scale-up operations; alternatively, a master’s degree with at least 3 years of such experience.
• Hands-on experience planning and executing pilot-scale cell culture operations.
• Experience with technology transfer and process scale-up.
• Excellent communication, technical writing, and presentation skills, with aptitude for creative problem solving.
• Demonstrated ability to collaborate and influence cross-functionally.
• Passion for inclusion, including understanding the business value of diverse teams, modeling inclusion, and embedding diversity in work practices.

Nice To Haves

• Working knowledge of single-use manufacturing technologies.
• Experience with data analysis tools such as JMP or Spotfire, creating and maintaining batch records, and authoring operating procedures and reports.
• Working knowledge of lab automation, real-time data-capture technologies, data management systems such as Ignition and DeltaV, data science, knowledge management, and data protection.

Responsibilities

• Maintain upstream Pilot Lab capabilities and perform facility-fit and material-generation runs to support cell culture process development and scale-up.
• Contribute to material-generation planning.
• Plan and execute pilot-scale cell culture operations using shake flasks, Wave systems, and 100L and 500L single-use bioreactors.
• Support process scale-up and implementation of new technologies in the Pilot Lab, including perfusion.
• Provide general laboratory support and routine maintenance, including maintenance of analytical equipment.
• Collect and analyze Pilot Lab run data in compliance with data integrity policy.
• Author and review batch records, protocols, project progress updates, and production summary reports.
• Transfer processes to the Pilot Lab on schedule and with a high success rate.
• Provide technical support for investigations of atypical Pilot run events and escalate as appropriate.
• Author and maintain Pilot Lab work instructions and standard operating procedures.
• Provide hands-on training to Pilot Lab operators and mentor junior team members in operational best practices, batch record completion, planning, and execution.
• Contribute to biologics manufacturing platform development and evaluate and implement new technologies and innovations to support fast first-in-human clinical trial timelines.
• Participate in cross-functional initiatives as needed.
• Adhere to department budget and all training, compliance, and safety requirements.

Benefits

• Discretionary annual bonus eligibility.
• Discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.
• Additional benefits package, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior