Downstream Pilot Plant Associate

Stark Pharma Solutions Inc; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. in California is seeking a Downstream Pilot Plant Associate with hands-on experience in downstream purification of viral vector gene therapies at pilot or production scale.

You will perform chromatography, TFF, ultrafiltration, and depth filtration, operate bioprocessing equipment, and ensure cGMP/GDP compliance, batch records, and documentation. Collaboration with Manufacturing, Quality, and Process Development is essential.

Qualifications

• 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.

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.

Skills

Communication skills

Technical writing

Education

Bachelor's degree in Biology/Biochemistry/Biotechnology/related

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.

Position

Downstream Pilot Plant Associate

Location

California

Duration

Long Term

Job Overview

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.

Key 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.

Required Qualifications

• 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.