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.
- 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.
- JOB LEVEL: Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- EXPERIENCE: Typically requires a university degree and a minimum of 2 years of related experience.
- COMPLEXITY: 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.
- SUPERVISION: Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
Wheeler Bio’s headquarters are in Oklahoma City, OK. Because it is expected that this individual will work and operate onsite, he or she will be required to relocate to the Oklahoma City headquarters to lead this expanding team.
- 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.