Associate Scientist - Purification Process Development

The Planet Group; Oceanside (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

The Planet Group seeks a purification process development scientist to lead design and execution of laboratory studies, supporting scale-up and transfer to GMP facilities.

You will mentor junior staff, ensure high-quality documentation, and advance platform development with new technologies to enable pivotal clinical trials.

Candidates typically hold an MS with 2+ years (BS with 4+ years) in chemical engineering, biochemistry, or bioengineering, with hands-on purification experience.

Qualifications

• M.S. with 2+ years or BS with 4+ years in a relevant scientific discipline.
• Hands-on purification operations experience and GMP familiarity are preferred.
• Experience in pivotal stage purification development and transfer to GMP facilities.

Responsibilities

• Contribute to experimental design and plan purification studies.
• Collect and analyze data; author protocols and reports.
• Support process transfer to internal and contract manufacturing facilities for GMP and non-GMP substances.
• Provide technical support for investigations and deviations.
• Maintain high-quality documentation in ELNs and records.
• Mentor junior team members in purification strategies and cross-functional work.
• Help establish and maintain a state-of-the-art purification lab.
• Execute platform development and evaluate new technologies for pivotal clinical trials.
• Participate in cross-functional initiatives and ensure compliance with safety requirements.

Skills

Centrifugation

Filtration

Purification screening

Chromatography

Tangential flow filtration

Virus inactivation/removal

Cross-functional collaboration

Statistics

Design of experiments

Data analysis

Communication skills

Education

Master's degree in chemical engineering, biochemistry, or related field

Bachelor's degree in chemical engineering, biochemistry, or related field

Tools

AKTA chromatography systems

UNICORN software

Job description

• 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.