This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Job Description Summary of Position: This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Global AH Quality strategy as well as applicable regulatory requirements. The position holder is responsible for and should have experience in product qualifications and technology transfer, process improvement, and process validation The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment. The manufacturing sites that are supported by the person in this position will include third parties producing AH Pharma products. The position holder will concentrate his/her activities primarily on the support of Global projects at external manufacturing sites. Major Assignments: 1.



Provide project management and/or technical oversight, planning, coordination and support to drug-product manufacturing sites for projects related to: i. API-related changes, including supplier and API-process changes ii. CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO; iii. Process Robustness and Product maintenance (e.g. due to regulatory changes) iv. life cycle management, technical trouble shooting v. Process and method validation/qualification vi. Overarching changes to products or materials. 2. Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (process robustness initiative) with target to improve efficacy (e.g. reducing off specs and cycle times, Right First time projects) at the manufacturing sites. Projects include: i. Stage-gate-process (R&D-to-CMO;) for current products (e.g. CMC-section review), ii. Transfers, iii. Change control for drug-products

📌 Associate Director Engineering (Maharashtra)
🏢 Msd
📍 Maharashtra