Description

Location: Oceanside, CA

100% Onsite - no hybrid opportunity

Focus: Downstream Process Development

Duration & Info: 1 year - this need will be for 1 year and this role is not looking to convert into FTE at this time; any opportunity for extension will not be known until closer to the end of this 1 year period (pending FTE return status); please source candidates seeking/okay with a contract role + this site is under multi-year site closure plans for the client side

Role:

• The Associate Scientist/Sr Associate Scientist, Purification Process Development (Pivotal and Commercial) role will contribute to all 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.

Specific 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.
• 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.

Education & Experience:

• M.S. with 3+ years or B.S. with 5+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Knowledge, Experience and Skills:

• Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is required.
• Experience with AKTA chromatography systems and UNICORN software is required
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Antibody drug conjugate experience is a plus.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is a plus.
• Demonstrated ability to collaborate and influence cross-functionally.
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
• Working knowledge of lab automation, data management, data science, knowledge management and data protection is a plus

Must Have's:

• Plan and execute assigned purification process development laboratory studies.
• Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports.
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities

Preferred Requirements:

• AKTA operation
• TFF Filtration/Viral Clearance
• Hamilton purification/High-throughput system operation