Manufacturing Specialist

Job Responsibilities:

• 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.