Associate Scientist, Purification Process Development

Job Title: Associate Scientist, Purification Process Development

Location: Oceanside, CA

Duration: 12 months

Description:

Official Job Title: Associate Scientist, Purification Process Development

Location: Oceanside, CA (Onsite 5 days)

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.
• 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/Skills/Experience:

• M.S. with 2+ years or BS with 4+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Preferred Qualifications:

• 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.