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, 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 setting 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) (Visakhapatnam)
🏢 Calscientific (india)
📍 Visakhapatnam