Scientist, Process Development
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. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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.
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
