Position : Project Lead/Subject Matter Expert (SME).

Job Location: Vizag/Hyderabad @ CMO Site.

Project Duration: 2 to 3 Years

:

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, positive 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

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