Planet Pharma
Overview
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 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. Demonstrate strong technical writing and communication skills. Always maintain a safe working environment and remain current with assigned training. Position Requirements
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. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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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 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. Demonstrate strong technical writing and communication skills. Always maintain a safe working environment and remain current with assigned training. Position Requirements
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. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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