Position : Project Lead/Subject Matter Expert (SME).
Job Location: Vizag/Hyderabad @ CMO Site.
Project Duration: 2 to 3 Years
Job description:
MS&T; – External Manufacturing | Key Role Summary
• Acts as the technical lead managing relationships and operations with CMOs, ensuring alignment with company standards.
• Provides hands-on support to external manufacturing network to drive operational excellence, product quality, and supply flow.
• Facilitates new product introductions, tech transfers, and lifecycle management across global/regional sites.
• Leads process scale-up, technology transfer, and validation activities to ensure robust and compliant manufacturing.
• Investigates and provides expertise on deviations, complaints, OOS/OOE/OOT events, and CAPAs, ensuring cGMP and regulatory compliance.
• Drives continuous improvement, efficiency gains, and deployment of new technologies/standards.
• Ensures strict adherence to global SOPs, guidelines, and regulatory expectations.




• Maintains processes in a validated state while monitoring external manufacturing performance and product quality.
• Works across global teams and partners, managing projects and aligning stakeholders.
• Ideal Candidate Profile:
• Strong background in manufacturing science, cGMP, and project management, with experience injectables & Sterile products, and capable of leading cross-functional initiatives.

Position Requirements
Education Required:
• Master’s Degree in Pharma, Science, Chemistry, or Chemical Engineering

Experience Required:
• 8-12 years pharmaceutical manufacturing/validation/other related experience for US FDA approved sites
• Strong experience in working with external manufacturing partners (CMOs, CDMOs, etc.)

Communication Skills Required:
• Good oral and written communication skills, attention to detail, ability to work independently, valuable people skills, demonstrated organizational skills.

Technical / Functional Knowledge:
• Strong technical background with expertise in pFM

📌 Project Lead/Subject Matter Expert (Mumbai)
🏢 Cal Scientific
📍 Mumbai