What are the responsibilities and job description for the Upstream Pilot Plant Associate position at Planet Pharma?
CONTRACT: 6-month extendable
MUST HAVES:
- B.S. degree in Biology, Biochemistry, Chemical Engineering, or related discipline with 4–6 years of experience in upstream process development or manufacturing support in bioprocessing
- Hands-on experience with mammalian or microbial cell culture, seed train expansion, bioreactor operations (bench, pilot, or production scale), and media/buffer preparation
Position Summary:
Join a growing team as a key member of the Manufacturing department where your contributions directly support the delivery of life-changing therapies to patients. As an Upstream Pilot Plant Associate, you will play an essential role in the successful production of high-quality Gene Therapy products. Your responsibilities will span a variety of activities, including upstream process execution (cell culture and bioreactor operations), maintaining GLP-compliant documentation, operating and maintaining cell culture equipment, authoring records and procedures, and contributing to continuous improvement initiatives within viral vector manufacturing.
Responsibilities:
• Execute upstream processes, including cell culture expansion, bioreactor operations (bench, pilot, and production scales), and media/buffer preparation.
• Operate and maintain upstream bioprocessing equipment such as wave/rocking platforms, stirred-tank bioreactors, incubators, and automated control systems.
• Prepare, sterilize, and manage cell culture consumables while ensuring aseptic technique in all operations.
• Maintain strict adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, technology transfer documents, and campaign summary reports.
• Ensure compliance with company SOPs, training requirements, and best practices for scale-up and technology transfer.
• Maintain facility readiness and support inspections through vigilant oversight of upstream operations.
• Utilize Quality Systems and Enterprise Resource Planning (ERP) tools to record and track production activities.
• Provide upstream process subject matter expertise and take ownership of assigned deliverables.
• Preferred: Experience conducting manufacturing investigations in biologics or cell culture based production.
• Demonstrate strong technical writing and communication skills.
• Always maintain a safe working environment and remain current with assigned training.
Position Requirements (Required and/or Preferred Skills, Experience and Education):
• B.S. degree in Biology, Biochemistry, Chemical Engineering, or related discipline with 4–6 years of experience in upstream process development or manufacturing support in bioprocessing.
• Hands-on experience with mammalian or microbial cell culture, seed train expansion, bioreactor operations (bench, pilot, or production scale), and media/buffer preparation.
• Knowledge and application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Proven ability to collaborate effectively within cross-functional teams in a manufacturing or development environment.
• Experience supporting manufacturing investigations, root cause analysis, and deviation resolution in biologics production.
• Familiarity with Quality Systems, Enterprise Resource Planning (ERP) platforms, and electronic documentation systems.
Salary : $65 - $75
