Our client, a Biopharmaceutical company, is looking for a Associate Scientist, Purification Process Development for their Oceanside, CA location.
Responsibilities:
The Associate Scientist, Purification Process Development (Pivotal and Commercial) will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for client biologics entities during pivotal and commercial development phases.
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.
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.
Requirements:
M.S. with 2+ years or BS 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 is required.
Experience with AKTA chromatography systems and UNICORN software is preferred
Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
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.