Downstream Pilot Plant Associate

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

We are seeking a Downstream Pilot Plant Associate with hands-on experience in downstream purification of viral vector gene therapies at pilot or production scale.

Responsibilities

• Perform downstream purification using chromatography, TFF, ultrafiltration, and depth filtration.
• Operate downstream bioprocessing equipment at pilot/production scale.
• Follow cGMP and Good Documentation Practices (GDP).
• Prepare and maintain batch records, SOPs, logbooks, and manufacturing documents.
• Support manufacturing investigations, troubleshooting, and root cause analysis.
• Collaborate with Manufacturing, Quality, and Process Development teams.
• Support process improvements, change controls, and technology transfer activities.
• Provide technical support and leadership during on-floor manufacturing activities.
• Maintain compliance with safety, training, and quality requirements.

Requirements

• Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or related field.
• 4–6+ years of experience in bioprocessing, downstream manufacturing, or process development.
• Hands-on viral vector gene therapy purification experience.
• Experience with chromatography, TFF, ultrafiltration, and depth filtration.
• Pilot or production-scale manufacturing experience.
• Strong cGMP/GDP knowledge and documentation experience.
• Experience with batch records, SOPs, and manufacturing investigations.
• Strong communication and technical writing skills.