Description: DUTIES AND RESPONSIBILITIES: * Schedule, procure material, and execute GMP production c...
Description: DUTIES AND RESPONSIBILITIES: * Schedule, procure material, and execute GMP production campaigns. * Train and supervise GMP production personnel. * Maintain production cleanroom facility and equipment per GMP requirements and company SOPs. * Maintain GMP production SOP document system, including production records, equipment records, material specifications, as well as employee training records and facility cleaning records. * Analyze, compile and present production batch data to the CMC management. * Participate in process technology transfer and manufacturing process troubleshooting. * Initiate and participate in quality investigations, as needed. * Work closely with other CMC and Quality team members to ensure successful, on time execution of batch production meeting quality standards. EDUCATION AND EXPERIENCE: * B.S. or M.S. Biology or related field. * 5 to 7 years' experience in a regulated GMP manufacturing environment with good cleanroom, cell culture, and aseptic techniques. * Minimum of 2 years of supervisory experience. Experience in GMP viral vector production and protein production is a plus. DESIRED KEY COMPETENCIES: * Excellent communication skills. * Self-motivated and independently minded. * Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function. * Self-organizer, meticulous hands-on habits, keen attention to detail. * Ability to adhere to rules and instructions per GMP regulations * Strong quantitative and analytical skills. * Responsive, can-do attitude. * Can coordinate parallel tasks across multiple projects, demonstrating prioritization. * Ability to quickly adapt to a rapidly changing environment and demands. * Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats. EOE MFDVSDL2017