Downstream Pilot Plant Specialist — Viral Vector Purification

Stark Pharma Solutions Inc; Los Angeles (CA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication skills

Technical writing

Formation

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

Description du poste

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.