Senior Associate Scientist, Biologics

Gilead Sciences • Foster City, CA

2d • $126,820 - $164,120

About The Position

The Senior Associate Scientist, Biologics Pilot Lab Operations will lead and execute 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 the lab’s capacity, efficiency, and process productivity. The position collaborates 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.

Nice To Haves

• Working knowledge of single-use manufacturing technologies.
• Excellent communication, technical writing, and presentation skills, with creative problem-solving aptitude.
• Demonstrated ability to collaborate and influence cross-functionally.
• 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 tools such as Ignition and DeltaV, data science, knowledge management, and data protection.
• A commitment to inclusion and understanding of the business value of diverse teams, with the ability to model and embed inclusion in work practices.

Responsibilities

• Maintain state-of-the-art upstream Pilot Lab capabilities to support advancement of the biologics pipeline, including facility-fit and material-generation runs for cell culture process development and scale-up.
• Contribute to material-generation planning 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 Pilot Lab technologies, such as perfusion.
• Provide routine lab support and maintenance, including for analytical equipment such as ViCell Blu, NovaFlex, and Cedex Bio.
• Collect and analyze Pilot Lab run data in compliance with data-integrity policy; author and review batch records, protocols, project updates, and production summary reports.
• Transfer processes to the Pilot Lab on schedule and with a high success rate; provide technical support for atypical-event investigations and escalate as appropriate.
• Author and maintain Pilot Lab work instructions and standard operating procedures.
• Train Pilot Lab operators hands-on and mentor junior team members on operational best practices, batch-record completion, and operation 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, training, compliance, and safety requirements.

Benefits

• Potential eligibility for a discretionary annual bonus.
• Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

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