Manufacturing Specialist Jobs

Job Title: Manufacturing Specialist - GMP

Company Overview:

Our client is a cutting-edge biotechnology company based in Boston, specializing in the development and production of induced pluripotent stem cells (iPSCs) for therapeutic applications. Their mission is to revolutionize healthcare through the use of regenerative medicine.

Position Summary:

The Manufacturing Specialist will be responsible for overseeing all manufacturing activities related to induced pluripotent stem cell production.

Responsibilities:

• Assist in the investigation and resolution of deviations, non-conformances, and out-of-specification results, ensuring appropriate corrective and preventive actions are implemented.
• Contribute to the training and onboarding of new manufacturing team members, ensuring adherence to safety guidelines and manufacturing procedures.
• Execute manufacturing processes for induced pluripotent stem cells, including cell culture, expansion, harvesting, and cryopreservation, following established procedures and protocols.
• Stay updated with industry trends, technological advancements, and regulatory changes related to iPSC manufacturing, sharing knowledge with the team and actively seeking continuous learning opportunities.
• Maintain accurate and complete manufacturing records and documentation, ensuring data integrity and compliance with regulatory guidelines.
• Ensure compliance with Good Manufacturing Practices (GMP) and standard operating procedures (SOPs) to maintain the highest quality standards and regulatory compliance.
• Perform routine maintenance, calibration, and troubleshooting of manufacturing equipment and instrumentation to ensure optimal performance.
• Collaborate with the Manufacturing Manager and cross-functional teams to support the efficient execution of manufacturing operations and achievement of production targets.
• Participate in the development and revision of manufacturing SOPs and batch records, reflecting improvements in processes and adherence to regulatory requirements.
• Support the implementation of process improvements and optimization initiatives to enhance efficiency, productivity, and quality within the manufacturing area.

Qualifications and Experience:

• A minimum of 3 years of experience in a manufacturing role within the biotech or pharmaceutical industry, with exposure to cell culture and GMP compliance.
• Familiarity with Good Manufacturing Practices (GMP) and adherence to quality systems in a regulated manufacturing environment.
• Bachelor's relevant scientific discipline (e.g., biology, biotechnology, bioengineering) is required.