Process Development Associate

Job Title: Process Development - Associate-Senior-C

Location: San Diego, California, 92111

Employment Type: 6 Month contract

Job Description:

Downstream Pilot Plant Associate

Join a growing team as a key member in the Manufacturing department where you can see the end result of your contributions benefit patients’ lives. As a Downstream Pilot Plant Associate, you play an integral role in ensuring the on-time delivery of quality Gene Therapy products. You will participate in diverse activities including downstream process execution, maintaining GLP documentation, operating and maintaining process equipment, authoring records and procedures, and supporting continuous improvement efforts for manufacturing viral vector gene therapy.

Responsibilities (Essential Role Responsibilities):

• Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration and depth filtration, at pilot and production scales.

• Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units.

• Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities.

• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements.

• Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting.

• Ensure compliance with company SOPs, training requirements, and scale-up best practices.

• Maintain facility readiness and support regulatory inspections through vigilant oversight.

• Utilize Quality Systems and ERP platforms to document and track manufacturing activities.

• Drive process improvements through the change control process or other initiatives.

• Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities.

• Provide process subject matter expertise and take ownership of assigned deliverables.

• Preferred: Experience conducting manufacturing investigations in biologics production.

• Demonstrate strong technical writing and communication skills.

• Maintain a safe working environment and stay current with all assigned training.

Position Requirements (Required and/or Preferred Skills, Experience and Education):

Qualifications

· B.S. degree in biology or related area with 4-6 years of experience working in process development or Manufacturing support in bioprocessing required

· Hands on experience with Chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience.

· Good manufacturing practices required

· Good documentation practices required

· Ability to effectively collaborate with team members

· Experience with manufacturing investigations for biologics manufacturing.

· Familiarity with Quality systems and Enterprise Resource Planning etc.