Downstream Pilot Plant Associate

Stark Pharma Solutions Inc; San Diego (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Downstream Pilot Plant Associate to join our Manufacturing team. The role focuses on executing downstream purification processes for gene therapy product manufacturing, maintaining GLP/GMP documentation, and supporting continuous improvement initiatives on the floor.

Ideal candidates hold a B.S. in Biology with 4–6 years of process development experience and hands-on chromatography, ultrafiltration, and depth filtration.

Qualifications

• B.S. degree in Biology or related field plus 4–6 years of process development experience.
• Hands-on chromatography, ultrafiltration and depth filtration at lab, pilot or production scale.
• Strong working knowledge of cGMP and GDP with documentation practices.

Responsibilities

• Perform downstream purification processes including chromatography, ultrafiltration, TFF, and depth filtration at pilot and production scales.
• Operate and maintain bioprocessing equipment and document batch records, SOPs, and tech transfer documents.
• Support investigations, root cause analysis, and process troubleshooting in collaboration with cross-functional teams.
• Ensure compliance with SOPs, training requirements, and scale-up best practices.

Skills

Chromatography

Ultrafiltration

Depth filtration

cGMP

GDP

Process development

Technical writing

Cross-functional collaboration

Education

B.S. in Biology

Tools

ERP platforms

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Downstream Pilot Plant Associate

Role

Seeking a Downstream Pilot Plant Associate to join a Manufacturing team supporting on‑time delivery of quality gene therapy products. This role executes downstream purification processes, maintains GLP/GMP documentation, operates and maintains process equipment, authors records and procedures, and supports continuous improvement efforts for viral vector gene therapy manufacturing.

Key Responsibilities

• Perform downstream purification processes; chromatography, ultrafiltration, tangential flow filtration (TFF), and depth filtration at pilot and production scales.
• Operate and maintain standard bioprocessing equipment (chromatography systems, ultracentrifuges, TFF units).
• Adhere strictly to cGMP and GDP in all activities.
• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specs, campaign summary reports, and tech transfer documents.
• Collaborate cross‑functionally on manufacturing investigations, root cause analysis, and process troubleshooting.
• Ensure compliance with SOPs, training requirements, and scale‑up best practices.
• Maintain facility readiness and support regulatory inspections.
• Use Quality Systems and ERP platforms to document and track manufacturing activities.
• Drive process improvements through change control and other initiatives.
• Provide on‑floor technical leadership and process subject matter expertise; may supervise or lead on‑floor activities.

Required

• B.S. degree in Biology or a related field, with 4 6 years of process development experience.
• Hands‑on experience with chromatography, ultrafiltration, and depth filtration (lab, pilot, or production scale).
• Strong working knowledge of cGMP and GDP.
• Ability to collaborate effectively across teams.
• Experience with manufacturing investigations for biologics preferred.
• Familiarity with Quality Systems and ERP platforms.
• Strong technical writing and communication skills.