Manager / Director of GMP Kilo Lab Operations

The Manager / Director of GMP Kilo Lab Operations at Porton USA, LLC is a pivotal role responsible for overseeing the Kilo Lab team and ensuring that all operations adhere to Good Manufacturing Practices (GMP). This position is based onsite in South Plainfield, NJ, and reports directly to the Sr. Director of GMP Operations. The successful candidate will manage the Kilo Lab operations to ensure high performance and compliance with GMP standards, while also facilitating the smooth technology transfer of research and development processes into the GMP manufacturing suites. In this role, the individual will prepare batch sheets and manage the technical input to batch records and other quality documents in accordance with ICH and FDA guidelines. The Manager / Director will also be responsible for adhering to Environmental Health and Safety (EHS) policies, maintaining a safe and orderly work environment, and training GMP personnel on batch record writing and related Standard Operating Procedures (SOPs). The position requires supervision of the execution of batch records for Active Pharmaceutical Ingredient (API) and intermediate production, ensuring compliance with SOPs and regulations. Additionally, the role involves overseeing in-process testing, cleaning protocols, and performing equipment qualifications while ensuring proper record-keeping. The Manager / Director will develop and implement team objectives, fostering a collaborative environment focused on continuous improvement and operational excellence, while facilitating communication between the Kilo Lab team and other departments to ensure effective collaboration.