Descripción del trabajo

Job Description

The Scientist, Biologics Pilot Lab Operations, will execute pilot scale purification operations to generate materials supporting toxicology studies, research, and biologics development activities. This role is responsible for maintaining Pilot Lab operation readiness, supporting staff training, and participating in technology evaluation in collaboration with process development groups to improve Pilot Lab operation capacity, efficiency, and process productivity. The Scientist will work collaboratively with cross-functional stakeholders and contribute to the successful filings of Gilead’s biologics entities.

Key Responsibilities

• Maintain a state-of-the-art purification lab that enables rapid assessment of new biologics entities, purification process development, and scaleup.
• Participate in material generation planning and execute pilot scale purification operations.
• Support process scaleup and implementation in the Pilot Lab.
• Collect and analyze data from Pilot Lab runs in compliance with data integrity policy. Author and review batch records, protocols, and reports.
• Assist in transferring processes to the Pilot Lab in a timely manner and provide technical support for Pilot run atypical event investigations.
• Author and maintain Pilot Lab work instructions, standard operating procedures, and training plans. Support training for Pilot Lab operators.
• Contribute to biologics manufacturing platform development and new technology/innovation evaluation and implementation to enable 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.

Qualifications / Skills / Experience

• M.S. in Chemical Engineering, Bio-engineering, Biochemical Engineering, Biochemistry, or related field with >4 years (or B.S. with >6 years) of industrial experience in biologics purification development and/or scaleup operations.
• Hands-on experience with pilot scale purification, operation planning, and execution.
• Experience in tech transfer and process scale-up.
• Working knowledge of single-use manufacturing technology.
• Proficient with Unicorn and working experience with Akta system (e.g., Pure, Avant, Pilot, and Ready).
• Experience in data analysis (e.g., JMP, Spotfire), creating and maintaining batch records, authoring operation procedures and reports.
• Working knowledge of lab automation, data management, data science, knowledge management, and data protection is a plus.
• Excellent communication, technical writing, and presentation skills, and aptitude for creative problem solving.
• Demonstrated ability to collaborate cross-functionally.
• Commitment to inclusion and diversity.