Manufacturing Science and Technology Engineer

As an experienced professional with a total of 15 years of work background, including 6.5 years in your current role, you will be responsible for driving technology transfer for Third party manufacturing, Loan license projects, and Abbotts own manufacturing plants. You will support the Abbott site MS&T team as needed and assist in the qualification of alternate suppliers for raw materials & API. Your role will also involve ensuring compliance with regulatory, quality, statutory, EHS, and Pharmacovigilance requirements. Your primary job function will require you to perform effective gap analysis between sender & receiving sites in terms of process & equipment, and provide solutions for smooth technology transfer. You will be responsible for preparing Master formula record & Technology transfer protocol for products identified for transfer, reviewing draft documents from receiving sites, and executing validation batches to demonstrate reproducibility in commercial batches. Additionally, you will troubleshoot and solve production process problems, contribute towards investigations of batch failures or complaints, and support new site due diligence, product acquisitions, and certifications. Your core responsibilities will also include improving knowledge in handling Parenteral products and other dosage forms, providing technical support for activities like Alternate Supplier Qualification and Material Harmonization, reviewing and approving change controls and technical documents, and supporting NPI activities such as Dossier review, Product certification, and FLQR approval. You will also extend support to I&D for new product launches, batch monitoring, and keeping track of ongoing projects to update senior management in a timely manner.,