Associate Scientist, Purification Process Development

An American biopharmaceutical company focused on researching and developing antiviral drugs for the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19.

About the role

This is a 12-month contract position located in Oceanside, CA (5 days onsite). Work authorization: USC or GC only.

Responsibilities

• Contribute to experimental design.
• Plan and execute assigned purification process development laboratory studies.
• Support process scale-up 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, execution, and process transfer.
• Help 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 B.S. with 4+ years of 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.

Pay

$40.00 - $45.27/hr on W2.

Benefits

• Medical, dental, and vision coverage.
• Participation in a company-sponsored retirement savings plan.
• Legal service plans offering access to attorneys for legal advice and representation.