Associate Scientist, Purification Process Development

About the role

Lead and execute aspects of purification development, including process development and process characterization at internal or external facilities for biologics entities during pivotal and commercial development phases. Additionally, lead and execute projects for purification process technology development and platform process evolution.

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 a 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 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–$45 per hour.