Scientist, Process Development
Gilead Sciences•Foster City, CA
•Onsite
About The Position
The Scientist, Purification Process Development (Pre-Pivotal) will lead and execute purification process development laboratory experimentation for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II) with minimal supervision. He/she will also design, lead and execute laboratory experimentation for purification process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.
Requirements
- Ph.D. in chemical engineering, bioengineering, biochemical engineering, biochemistry or related field with 0+ years or M.S. with 4+ years or B.S. with 6+ years industrial experience in biologics purification development.
- Hands-on laboratory operations experience bench and pilot scale chromatography, TFF, VF and depth filtration.
- Experience in pre-pivotal stage purification process development, scaleup and implementation in GMP and non GMP manufacturing facilities.
- Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
Nice To Haves
- Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
- Demonstrated ability to collaborate and influence cross-functionally.
- Working knowledge of lab automation, data management, data science, knowledge management and data protection.
- Knowledge in single-use manufacturing technology and cGMP guideline is a plus.
- Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.
Responsibilities
- Establish and maintain a state-of-the-art purification lab that enables rapid new biologics entities manufacturability assessment, purification process development and scaleup.
- Lead experimental design for purification unit operation(s).
- Plan and execute purification process development laboratory studies with minimal supervision.
- Support process scaleup and implementation in internal and external GMP facilities.
- Collect and analyze data from laboratory experiments in compliance with data integrity policy.
- Author and review experimental protocols and reports.
- Support and may lead process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate.
- Provide oversight at internal and external manufacturing facilities as person-in-plant.
- Provide technical support for manufacturing atypical event investigations.
- Support non-GMP pilot lab operations.
- Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
- Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
- Lead purification platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.
- Contribute to workflow improvements for screening lead molecules with optimal developability.
- Participate in cross functional initiatives as needed.
- Adhere to department budget and all training, compliance and safety requirements.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
