Meet Life Sciences
Process Development Associate
Meet Life Sciences, San Diego, California, United States, 92189
Direct message the job poster from Meet Life Sciences
Department:
Manufacturing / Technical Operations
Position Summary
The Downstream Pilot Plant Associate plays a critical role in supporting the on‑time delivery of high‑quality gene therapy products. This position is responsible for executing downstream purification processes, maintaining GLP/GDP‑compliant documentation, operating bioprocessing equipment, and contributing to continuous improvement and process support activities within a pilot‑scale and production environment.
Key Responsibilities
Execute downstream purification operations including chromatography, ultrafiltration, tangential flow filtration (TFF), ultracentrifugation, and depth filtration at pilot and production scales.
Operate and maintain standard bioprocessing equipment such as chromatography systems, TFF units, and ultracentrifuges.
Adhere to cGMP and GDP standards in all manufacturing activities.
Prepare, review, and maintain batch records, SOPs, logbooks, raw material specs, campaign reports, and technology transfer documentation.
Collaborate cross‑functionally to support manufacturing investigations, root cause analysis, and process troubleshooting.
Ensure facility readiness, compliance with internal SOPs, and support regulatory inspections.
Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
Contribute to process improvements through change control and operational excellence initiatives.
Serve as a subject matter resource for assigned processes and may supervise on‑floor activities.
Maintain a safe, compliant working environment and complete all required training.
Qualifications
B.S. in Biology or a related discipline.
4–6 years of experience in process development or manufacturing support within bioprocessing.
Hands‑on experience with chromatography, ultrafiltration, depth filtration, and related downstream technologies.
Strong understanding of cGMP and GDP requirements.
Experience supporting manufacturing investigations in biologics is preferred.
Familiarity with Quality Systems and ERP platforms.
Strong technical writing, communication, and team collaboration skills.
Seniority level:
Mid‑Senior level
Employment type:
Contract
Job function:
Analyst and Manufacturing
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
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Department:
Manufacturing / Technical Operations
Position Summary
The Downstream Pilot Plant Associate plays a critical role in supporting the on‑time delivery of high‑quality gene therapy products. This position is responsible for executing downstream purification processes, maintaining GLP/GDP‑compliant documentation, operating bioprocessing equipment, and contributing to continuous improvement and process support activities within a pilot‑scale and production environment.
Key Responsibilities
Execute downstream purification operations including chromatography, ultrafiltration, tangential flow filtration (TFF), ultracentrifugation, and depth filtration at pilot and production scales.
Operate and maintain standard bioprocessing equipment such as chromatography systems, TFF units, and ultracentrifuges.
Adhere to cGMP and GDP standards in all manufacturing activities.
Prepare, review, and maintain batch records, SOPs, logbooks, raw material specs, campaign reports, and technology transfer documentation.
Collaborate cross‑functionally to support manufacturing investigations, root cause analysis, and process troubleshooting.
Ensure facility readiness, compliance with internal SOPs, and support regulatory inspections.
Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
Contribute to process improvements through change control and operational excellence initiatives.
Serve as a subject matter resource for assigned processes and may supervise on‑floor activities.
Maintain a safe, compliant working environment and complete all required training.
Qualifications
B.S. in Biology or a related discipline.
4–6 years of experience in process development or manufacturing support within bioprocessing.
Hands‑on experience with chromatography, ultrafiltration, depth filtration, and related downstream technologies.
Strong understanding of cGMP and GDP requirements.
Experience supporting manufacturing investigations in biologics is preferred.
Familiarity with Quality Systems and ERP platforms.
Strong technical writing, communication, and team collaboration skills.
Seniority level:
Mid‑Senior level
Employment type:
Contract
Job function:
Analyst and Manufacturing
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
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