Associate Director of Manufacturing

Job Description Job Description POSITION SUMMARY: The Associate Director of Manufacturing is responsible for training and supervising manufacturing personnel while leading GMP-compliant fill/finish operations. This role oversees the execution of manufacturing activities, ensuring proper documentation, reporting, and record management. Provides leadership support for equipment monitoring, troubleshooting, maintenance, and validation to ensure efficient and compliant manufacturing processes PRINCIPAL DUTIES: Execute and/or monitor the Manufacturing processes and procedural activities as required for a GMP compliant Fill/Finish operation. Serve as Subject Matter Expert (SME) in aseptic operations, including filling and preparation activities such as washing, autoclaving, formulation and associated support processes, Manage, initiate and oversee the set-up of manufacturing equipment including activities required for validation activities. Assist in designing and executing validation protocols and or machinability studies. Support the preparation and execution of validation related qualification documents and the resourcing of associated tasks (engineering batches, aseptic process simulation, validation activities). Develop and implement operator training strategies, including qualification plans, technical training, aseptic behavior training, and knowledge transfer for new products. Skilled in troubleshooting various equipment as required for the manufacturing process. Perform technical evaluation of manufacturing related information and provide management with status reports including information required for decision-making purposes. Writing and/or review of Process Support operational documentation (Master Batch Records, SOPs, Work Instructions, Deviations, CAPAs Change Controls, Complaints). Directly accountable for production schedule adherence. Train, mentor and supervise employees within manufacturing areas. Ensure that manufacturing systems and processes are effective and compliant and can be defended to regulatory agencies. Initiate problem solving, trouble-shooting and technical decision-making commensurate with level of experience. Strong knowledge of GMP procedures and requirements, as related to the position. Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation. Ensure batch records and logbooks are completed and reviewed in a timely manner to support batch release. Train and supervise employees within manufacturing areas, as applicable. Ensure all training is thorough and documented. Perform various manufacturing duties according to the GMP guidelines and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPs. Ensure staff maintains and tracks manufacturing supplies and product specific materials within the manufacturing areas. Manage and ensure that all activities within the ERP system are completed real time to ensure accurate inventory levels and usage. Written and oral skills at a level commensurate for interaction with staff, vendors, clients, and auditors as necessary. QUALIFICATIONS & EXPERIENCE: A minimum of BS is Chemical Engineering, Biology, or life science, with and advanced degree (MS) preferred, or equivalent relevant experience. 10 – 12 years of relevant experience in the pharmaceutical industry, with at least 5 years in a leadership role. Strong knowledge of Drug Product manufacturing technologies and processes to include: Vial Lines (stoppering and capping) Syringe Lines within RABS Cartridge lines Manual filling equipment Knowledge of cGMP, FDA, DEA, and related international regulations.