Manufacturing, Science, and Technology Specialist

The ideal candidate for this position should have a total work experience of 15 years, with 6.5 years of experience in the current role. The candidate should possess a background in Formulation Development, Technology Transfer, Root Cause Investigations, and Project Management. As a Technology Transfer Specialist, your primary responsibility will be to drive technology transfer for Third-party manufacturing, Loan license projects, and Abbott's manufacturing plants. You will also be required to support Abbott site MS&T team as per the project requirements and assist in the qualification of alternate suppliers for raw materials & API. Ensuring compliance with regulatory, quality, statutory, EHS, and Pharmacovigilance requirements will be a crucial part of your role. Your core responsibilities will include conducting a thorough gap analysis between the sender and receiving sites in terms of processes and equipment to facilitate smooth technology transfer. You will be responsible for preparing Master Formula Record and Technology Transfer Protocol for products identified for transfer and reviewing draft documents related to manufacturing, process validations, and product analysis. Additionally, you will execute validation batches and ensure reproducibility in commercial batches, review process validation batch documents, and provide support for FLQR approvals. Furthermore, you will troubleshoot and resolve production process issues at the manufacturing site, investigate commercial batch failures or market complaints, and contribute to appropriate CAPA implementation. Conducting due diligence of new sites, improving knowledge base for handling Parenteral products, extending technical support for Alternate Supplier Qualification and Material Harmonization activities, and authoring, reviewing, and approving technical documents will be part of your routine tasks. You will also support NPI activities like Dossier review, Product certification, and FLQR approval, assist in new product launches, batch monitoring, and FLQR approval, and keep track of ongoing projects while updating senior management in advance. Your role will encompass a wide range of responsibilities aimed at ensuring successful technology transfer and compliance with industry standards and regulations.,