Downstream Pilot Plant Associate

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 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.

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.

Requirements

• 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.