Senior Associate Scientist

Descrizione del lavoro

The Senior Associate Scientist, Biologics Pilot Lab Operations will plan and execute pilot scale purification operations to generate materials to support toxicology studies as well as Research and Biologics Development activities. (S)he will be responsible for Pilot Lab operation readiness, staff training, innovation and technology evaluation in collaboration with process development groups to improve Pilot Lab operation capacity, efficiency and process productivity. This role is expected to 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 new biologics entities manufacturability assessment, purification process development and scaleup.

• Contribute to material generation planning. 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.
• Transfer process to the Pilot Lab timely and with high success rate. Provide technical support for Pilot run atypical event investigations.
• Collect and analyze data from Pilot Lab runs in compliance with data integrity policy. Author and review batch records, protocols and reports.
• Mentor junior team members on Pilot Lab operation, batch record authoring, operation planning and execution as well as process transfer.
• Contribute to biologics manufacturing platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.
• Participate in cross functional initiatives as needed.
• Adhere to department budget and all training, compliance and safety requirements.

Basic Qualifications:

• B.S. with 5+ years of industrial experience in biologics purification development and/or scaleup operations OR M.S. in Chemical Engineering, Bioengineering, Biochemical Engineering, Biochemistry or related field with 3+ years' experience.
• Hands-on experience on pilot scale purification, operation planning and execution.
• Experience in tech transfer and process scale-up.
• 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.

Preferred Knowledge, Experience and Skills.

• Working knowledge in single-use manufacturing technology.
• 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 and influence cross-functionally.
• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.