Gilead Sciences, Inc.
Associate Scientist, Purification Process Development – Pivotal & Commercial Bio
Gilead Sciences, Inc., Foster City, California, United States, 94420
Associate Scientist, Purification Process Development – Pivotal & Commercial Biologics
The
Associate Scientist, Purification Process Development (Pivotal & Commercial)
will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution.
Key Responsibilities
Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. 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 experimental protocols and reports.
Support process transfer to internal and contract manufacturing facilities to produce GMP and non‑GMP drug substances on time and with high success rate.
Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
Provide technical support for manufacturing atypical event investigations.
Ensure high‑quality documentation in electronic laboratory notebooks, protocols and reports.
Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
Help to establish and maintain a state‑of‑the‑art purification lab.
Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials.
Participate in cross‑functional initiatives as needed.
Adhere to department budget and all training, compliance and safety requirements.
Qualifications
M.S. with 2+ years or B.S. with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
Hands‑on laboratory operations experience with purification process operations, including centrifugation, normal flow filtration, high‑throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal.
Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
Experience with AKTA chromatography systems and UNICORN software (preferred).
Working knowledge of lab automation, data management, data science, knowledge management and data protection.
Demonstrated ability to collaborate and influence cross‑functionally.
Experience in statistics, design‑of‑experiments, and data analysis (e.g. JMP, Spotfire).
Motivated self‑starter with excellent interpersonal and organizational skills, excellent verbal communication, oral presentation, and scientific writing skills.
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Associate Scientist, Purification Process Development (Pivotal & Commercial)
will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution.
Key Responsibilities
Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. 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 experimental protocols and reports.
Support process transfer to internal and contract manufacturing facilities to produce GMP and non‑GMP drug substances on time and with high success rate.
Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
Provide technical support for manufacturing atypical event investigations.
Ensure high‑quality documentation in electronic laboratory notebooks, protocols and reports.
Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
Help to establish and maintain a state‑of‑the‑art purification lab.
Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials.
Participate in cross‑functional initiatives as needed.
Adhere to department budget and all training, compliance and safety requirements.
Qualifications
M.S. with 2+ years or B.S. with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
Hands‑on laboratory operations experience with purification process operations, including centrifugation, normal flow filtration, high‑throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal.
Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
Experience with AKTA chromatography systems and UNICORN software (preferred).
Working knowledge of lab automation, data management, data science, knowledge management and data protection.
Demonstrated ability to collaborate and influence cross‑functionally.
Experience in statistics, design‑of‑experiments, and data analysis (e.g. JMP, Spotfire).
Motivated self‑starter with excellent interpersonal and organizational skills, excellent verbal communication, oral presentation, and scientific writing skills.
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