Senior Specialist, Downstream Process _Operations (Maharashtra)

Senior Specialist, Downstream Process _Operations (Maharashtra)

14 Sep
|
Msd
|
Maharashtra

14 Sep

Msd

Maharashtra

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 Senior Manager, Downstream Process _Operations The External Manufacturing, senior specialist will support a technical team interfacing between our Company and External Partners (EP) in the Biologics Drug substance manufacturing area. This individual will support the platform lead(s) in the execution of technical transfers to and from External Partners through process validation completion and/or provide global technical operations support for continuous commercial manufacturing at an External Partner. The Specialist (Biologics External Manufacturing) will provide operational support to the platform lead and to the Focused Factory. Key elements of this role include supporting team/partner interactions, proactive analysis of process performance, supporting change management, deviations/investigations, resolution of production issues,



regulatory filing support and supporting continuous improvement initiatives with partners. The ideal candidate will be able to travel to domestic partner sites to effectively manage the partnership and associated activities and will also have effective communication skills and tools for remote support to the partnerships/virtual sites. Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g., manufacturing, technology, validation, engineering, quality, analytical, drug substance unit operations such as downstream/purification processes, Viral clearance studies/validations and establishing the cold chain processes). Primary Activities will include: Reports to the platform lead (or delegate) and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues. Supports facility start-up and technical tran

📌 Senior Specialist, Downstream Process _Operations (Maharashtra)
🏢 Msd
📍 Maharashtra

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