MS&T

As a candidate for the position, you will be responsible for driving technology transfer for third-party manufacturing, loan license projects, and Abbott's own manufacturing plants. Your role will also involve supporting Abbott site MS&T team as per requirements and assisting in the qualification of alternate suppliers for raw materials & API. You will need to ensure compliance with regulatory, quality, statutory, EHS, and Pharmacovigilance requirements. Your primary job functions will include performing effective gap analysis between the sender & receiving site in process & equipment, preparing Master formula record & Technology transfer protocol for products identified for transfer, and reviewing draft documents pertaining to manufacturing, process validations & analysis of products under transfer. You will also be responsible for executing validation batches, reviewing executed process validation batch documents, troubleshooting and solving production process problems, and contributing towards appropriate CAPA. Additionally, you will need to carry out due diligence of new sites, work towards improving knowledge base for handling of Parenteral products, provide technical support for activities like Alternate Supplier Qualification and Material Harmonization, and author, review & approve technical documents. Your role will also involve extending support to NPI activities, I&D for new product launches, and keeping track of ongoing projects to update senior management beforehand. Qualifications required for this role include: - Total experience (in years): 15 - Experience in current role (in years): 6.5 - Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management This job provides a challenging opportunity for individuals with significant experience in formulation development and technology transfer to drive critical projects and ensure compliance with industry standards and regulations.,