What are the responsibilities and job description for the Manufacturing Supervisor position at Azzur Group?
- Oversee and supervise GMP manufacturing processes for cell culture-based production, ensuring strict compliance with established protocols and regulatory standards
- Lead routine tasks such as media preparation, cell inoculation, bioreactor operation, and harvest operations, ensuring meticulous execution and adherence to quality parameters
- Foster collaboration with cross-functional teams, including Quality Control and Quality Assurance, to uphold product quality and regulatory compliance
- Spearhead troubleshooting efforts and resolution of process deviations, conducting root cause analyses and implementing corrective measures to optimize manufacturing efficiency
- Maintain comprehensive documentation of all manufacturing activities in accordance with GMP standards, ensuring the accuracy and completeness of batch records and related documentation
- Play a pivotal role in technology transfer activities, leveraging expertise in cell culture processes to contribute to process enhancement initiatives
- Facilitate the training and development of junior team members, actively participating in the formulation of standard operating procedures (SOPs) pertaining to cell culture manufacturing
- Ensure the upkeep of equipment and work areas in accordance with safety protocols and guidelines, fostering a culture of safety and compliance
- Bachelor's degree in a pertinent scientific discipline (Biotechnology, Biochemistry, Biology, or a related field)
- Over 8 years of hands-on experience in GMP manufacturing, with a specialized focus on cell culture processes
- Profound understanding of bioreactor operations, aseptic techniques, and upstream processing. Experience with tangential flow filtration, ultracentrifugation and bulk fill downstream operations is a plus
- Experience with adherent cell culture preferred
- Familiarity with regulatory requirements governing the production of biopharmaceuticals, including FDA and EMA guidelines
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
