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: 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 (SME) (Hyderabad)
🏢 Calscientific (india)
📍 Hyderabad