Project Lead/Subject Matter Expert (SME). Job

Location:
Hyderabad/Vizag @ CMO Site. Project Duration: 3 Years + extendable

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:
• Positive oral and written communication skills, attention to detail, ability to work independently, good people skills, demonstrated organizational skills. Technical / Functional Knowledge:
• Strong technical background with expertise in pFMEA, manufacturing processes, process development, and scale-up, OpEx, Lean Six-Sigma
• Excellent risk assessment, root-cause analysis, problem-solving, troubleshooting & analytical skills
• Ability to communicate complex technical concepts clearly to both technical and non-technical stakeholders.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Ability to work collaboratively in a team environment and build relationships with external partners.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with manufacturing management systems (e.g., SAP, MES).
• Thorough familiarity with cGMPs, SOP's, relevant government regulations, and current industry standards. Company/Industry Related Knowledge:
• Needs to be experienced in Sterile / injectable Products Manufacturing and Technologies in Pharma Industry

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