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Job Title


GM – Manufacturing CoE - (Aseptic & Sterile)


Company : Stanley Cowton International


Location : Aurangabad, Maharashtra


Created : 2025-12-21


Job Type : Full Time


Job Description

General Manager – Manufacturing Centre of Excellence (Aseptic & Sterile)Location: Nagpur, IndiaStanley Cowton International has been retained by a global pharmaceutical manufacturer to appoint a senior leader to build and lead a Manufacturing Centre of Excellence focused on aseptic and sterile operations.This is a newly created, high-impact role for a recognised sterile expert who wants to shape strategy, influence multiple facilities, and raise standards to best-in-class across complex injectable manufacturing.The OpportunityThis position sits above day-to-day production and carries a clear mandate to define, implement, and sustain world-class aseptic practices. You will act as the sterile authority for the organisation, partnering closely with site leadership, quality, microbiology, and engineering teams.The business is well invested in modern sterile technology, including advanced filling lines, isolators, and automation. The focus now is on deepening sterile expertise, strengthening sterility assurance, and embedding a consistent aseptic culture across sites.The role offers strong visibility, autonomy, and long-term scope as the organisation expands further into complex injectables and, over time, biotech manufacturing.Key ResponsibilitiesEstablish and lead a Manufacturing CoE for aseptic and sterile operationsOwn and drive sterility assurance strategy, including CCS, EM programmes, media fills, and contamination controlLead EU GMP Annex 1 implementation and ensure inspection readiness for global regulatorsAct as subject matter expert during regulatory inspections and internal auditsStandardise aseptic practices across lines, shifts, and sitesLead sterile investigations, root cause analysis, and CAPA effectivenessBuild, coach, and develop sterile capability through structured training and knowledge transferInfluence senior stakeholders in a multi-site, matrix environmentRequirementsExtensive experience in sterile and aseptic pharmaceutical manufacturing, ideally within injectablesDeep, practical expertise in EU GMP Annex 1 with exposure to US FDA inspectionsProven ownership of sterility assurance and contamination control programmesBackground in microbiology, quality, engineering, or sterile operationsExperience operating across multiple sites or within a Centre of Excellence modelStrong change leadership, communication, and influencing skillsWillingness to be based in Nagpur and travel regularly between manufacturing sitesWhy Consider This RoleRare opportunity to build a sterile Centre of Excellence from the ground upStrategic, retained search with direct access to senior leadershipStrong technology platform with ambition to reach best-in-class sterile standardsClear long-term career progression as the organisation expands in complexity and scaleAll applications and discussions will be handled in strict confidence.