We are actively seeking a highly skilled and experienced Manufacturing Specialist specializing in cell culture to join our dynamic team. As a Manufacturing Specialist, you will play a pivotal role in ensuring the successful execution of cell culture processes within a Good Manufacturing Practice (GMP) environment. The ideal candidate will bring expertise in cell culture techniques and a strong understanding of regulatory compliance.
- Oversee and execute GMP manufacturing processes for cell culture-based production, ensuring adherence to established protocols and regulatory guidelines.
- Lead and coordinate cell culture activities, including media preparation, cell inoculation, bioreactor operation, and harvest operations with a focus on precision and quality.
- Collaborate closely with cross-functional teams, including Quality Control and Quality Assurance, to maintain product quality and compliance with regulatory standards.
- Investigate and resolve process deviations, applying root cause analysis and implementing corrective actions to ensure manufacturing efficiency and product quality.
- Ensure thorough and accurate documentation of all manufacturing activities in compliance with GMP standards, including the preparation of batch records and associated documentation.
- Contribute to technology transfer activities, providing subject matter expertise in cell culture processes and actively participating in process improvement initiatives.
- Mentor and train junior team members, sharing knowledge and best practices to facilitate their professional development.
- Maintain equipment and work areas in accordance with safety protocols, ensuring a clean and organized environment.
- 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).
- 5+ years of hands-on experience in GMP manufacturing, with a specialized focus on cell culture processes.
- In-depth knowledge of bioreactor operations, aseptic techniques, and upstream processing.
- Familiarity with regulatory requirements for the production of biopharmaceuticals, including FDA and EMA guidelines.
- Strong analytical and problem-solving skills, with the ability to optimize and troubleshoot manufacturing processes.
- Excellent communication and collaboration skills, with the ability to work effectively within cross-functional teams.
- Detail-oriented and committed to maintaining accurate and compliant documentation.