Job Summary:

Support the Head of MS&T in the new products development and tech transfer projects, including the pilot and commercial lots manufacturing. Also support in preparing technical documentation for use in manufacturing, quality control, and regulatory departments. Must possess strong technical skills to troubleshoot issues and enhance existing formulations.

Major Responsibilities:

Provide assistant to Head of MS&T to perform all activities in MS&T area including Introduction of new products / formulation and Product re-formulationParticipate and provide galenical based guidance to validation/verification, TMT studies examined for existing or new products manufactured at Abbott Sites and PK TPMsResponsible to work on product re-launch and line extension (Geo-extension) of commercial products and Alternate supplier qualificationResolve problems or any other issues to maintain a robust flow of finished products from TPMCoordination with Regional MS&T team for product remediation and Implementation of CI projects and process improvement.Execution of stability lots of new projects and Monitoring of cGMP in MS&T areaReview of proposed manufacturing MO/directions due to CIP and other reasonHandling of different projects related to ASQ cost and process improvement with cGMPResponsible for the EHS, GMP and GLP maintenance in MS&T areaWriting and updating of SOPs for all mfg. equipment / system used in MS&T, implementation of all SOPs during workingResponsible to develop bill of material manufacturing direction new material codes specification and packaging commoditiesSelecting suitable method for conventional method to automated techniques according to the characteristics of active/excipients used in new formulation for velocity process improvementResponsible for formulation changes, testing limits, and documentationsEvaluate solvent selection, bioequivalence, and tablet color matching as and if required according to the characteristics of active/excipients used in the new formula

Education/Knowledge & Experience:

Science Graduate/Master; preferably Pharm D5-6 years’ experience in the same capacity Proficient in MS OfficeTeamwork and problem-solving skills