Develop and implement process control strategies to optimize manufacturing operations and ensure high-quality production.
Support technology transfers for both early- and late-phase biopharmaceutical manufacturing processes.
Stay informed on industry advancements and innovative manufacturing approaches to drive continuous process improvements.
Operate and maintain production systems in a cGMP environment, ensuring compliance with regulatory standards and inspection readiness.
Apply expertise in cell culture techniques and biopharmaceutical production, working with upstream (seed train, media preparation, fermentation, harvest) and/or downstream (buffer preparation, chromatography, filtration) processes.
Support the development and production of advanced therapies, including applications in cell and gene therapy, through hands-on execution of aseptic techniques.
Maintain inventory control, process systems, and documentation to ensure accurate records and adherence to safety and environmental protocols.
Utilize automation systems to streamline production tasks and align with operational demands.
Contribute to clinical and commercial manufacturing programs by providing technical expertise and practical support across multiple areas of production.
Troubleshoot and resolve process deviations to maintain operational efficiency and product quality.
Qualifications
Associate's or Bachelors's Degree in Biological Sciences, Physical Sciences, Engineering, a related field with 2-5 years of experience in biologics, gene therapy, or cell therapy manufacturing within a regulated environment Preferred.
HS diploma or GED with 6+ years in mechanical production or manufacturing experience.
Strong understanding of aseptic processing, GMP compliance, and biopharmaceutical production workflows.
Hands-on experience with mammalian cell culture, process automation, and equipment sterilization.
Proven ability to lead process improvements and technology transfers in a fast-paced manufacturing setting.
Excellent problem-solving, collaboration, and communication skills, with a focus on precision in documentation and execution.
