Manufacturing Associate (I-III)

POSITION SUMMARY:
We are seeking a highly skilled and experienced GMP Manufacturing Associate specializing in cell culture and downstream processing to join our dynamic team. The ideal candidate should have 2-5 years of relevant experience in a GMP (Good Manufacturing Practice) environment, with a strong background in cell culture techniques. As a key member of our manufacturing team, you will play a crucial role in the production of high-quality biopharmaceutical products.

RESPONSIBILITIES:

• Execute and monitor GMP manufacturing processes for cell culture-based production, ensuring compliance with established protocols and regulatory guidelines.
• Perform routine tasks such as media preparation, cell inoculation, bioreactor operation, and harvest operations with precision and attention to detail.
• Collaborate with cross-functional teams, including Quality Control and Quality Assurance, to ensure product quality and compliance with regulatory standards.
• Troubleshoot and resolve process deviations, identifying root causes and implementing corrective actions to maintain manufacturing efficiency.
• Document all manufacturing activities in accordance with GMP standards, maintaining accurate and complete batch records and documentation.
• Participate in technology transfer activities, providing expertise in cell culture processes and contributing to process improvement initiatives.
• Contribute to the training of junior team members and assist in the development of standard operating procedures (SOPs) related to cell culture manufacturing.
• Maintain equipment and work areas in a clean and organized manner, following safety protocols and guidelines.

PROFESSIONAL SCOPE:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Typically requires a university degree and a minimum of 2 years of related experience.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

QUALIFICATIONS:

• Bachelor's degree in a relevant scientific discipline (Biotechnology, Biochemistry, Biology, or related field).
• 2-5 years of hands-on experience in GMP manufacturing, with a focus on cell culture processes.
• Strong knowledge of bioreactor operations, aseptic techniques, and upstream processing.
• Familiarity with regulatory requirements for the production of biopharmaceuticals, including FDA and EMA guidelines.
• Excellent problem-solving and analytical skills, with the ability to troubleshoot and optimize manufacturing processes.
• Effective communication and teamwork skills, with the ability to collaborate across departments and contribute to a positive team culture.
• Detail-oriented and capable of maintaining accurate documentation in compliance with GMP standards.

Reach out to learn more:
alanah@peoplewithchemistry.com
858-429-6147