Associate Scientist, Purification Process Development

Planet Pharma; Oceanside (CA); On-site; USD 55,000 - 62,000; Full time

Job summary

Planet Pharma in Oceanside, CA is seeking an Associate Scientist for purification process development across pivotal and commercial programs. You will lead purification development activities, design experiments, and help transfer processes to GMP facilities, supporting scale-up and tech transfer.

The role requires hands-on lab experience in purification operations, data analysis, and collaboration with cross-functional teams. Experience with AKTA systems and UNICORN software is preferred.

Qualifications

• M.S. with 2+ years or B.S. with 4+ years in a relevant scientific discipline.
• Hands-on purification operation experience including chromatography and filtration.
• Experience with data management, statistics, and data integrity.

Responsibilities

• Lead purification process development studies and support scale-up in GMP facilities.
• Plan experiments, collect data, and author reports with data integrity.
• Support process transfer to internal and contract manufacturing facilities.
• Mentor junior members and contribute to platform development and new tech evaluation.
• Ensure high-quality documentation and adherence to safety requirements.

Skills

M.S. / B.S. in a relevant scientific:

Cross-functional collaboration

Verbal communication skills

Education

M.S. in chemical engineering / biochemistry / bioengineering

B.S. in a relevant scientific field

Tools

AKTA chromatography

UNICORN software

Job description

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 the biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution.

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.

Pay Range: 40-45/hr