The Material Management Specialist is responsible for the ordering, inventory control, and GMP documentation of raw materials, and consumables supporting drug substance manufacturing at a Kemwell Biopharma Pvt Ltd. This role ensures materials are available to support production schedules while maintaining full GMP compliance, inventory accuracy, and traceability from vendor receipt through use in manufacturing, in support of multiple client programs.

Key Responsibilities

Material Ordering / Procurement Support

- Generate and place purchase requisitions as per the identified BoM by respective technical leads for raw materials, single-use components, and consumables based on production schedules, MRP (Material Requirements Planning) output, and safety stock levels.
- Coordinate with Procurement/Sourcing to confirm vendor lead times, pricing, and delivery schedules; expedite orders as needed to prevent production delays.
- Monitor open purchase order status and proactively resolve delivery delays, backorders, or vendor supply issues.
- Support client-specific material forecasting and campaign-based ordering for multiple concurrent manufacturing programs.
- Maintain and update reorder points, minimum/maximum stock levels, and lead-time data in the SAP system.
- Coordinate with Quality Assurance on approved vendor list (AVL) status prior to placing orders with new suppliers.
- Creating material codes for newly identified material, initiating material categorization forms, and coordinate with cross functional teams for timely release of approved vendor list.

Inventory Management

- Maintain accurate real-time inventory records in the SAP system.
- Perform cycle counts and support annual physical inventory reconciliation; investigate and resolve inventory discrepancies.
- Manage material status transactions (Quarantine Released Rejected Consumed) in accordance with QA disposition.




- Monitor and manage material expiry/retest dates; flag materials approaching expiration and coordinate re-test or disposition with QA.
- Coordinate material returns, disposal, and destruction of rejected, expired, or excess materials per site procedures.

Documentation & GMP Compliance

- Complete and maintain GMP documentation associated with material ordering.
- Ensure Certificates of Analysis/Conformance (CoA/CoC) are received and submit to QC for specification preparation.
- Initiate and support deviations/investigations related to material discrepancies (e.g., damaged shipments, quantity variances, expired material use, mislabeling) and contribute to root cause analysis and CAPA.
- Support change controls related to material specification changes, alternate vendor qualification, or storage condition changes.
- Participate in periodic SOP review/revision related to material management processes.

Educational Qualification : M.Sc. in Biotechnology/Microbiology, B. Pharm or equivalent; or equivalent combination of education and experience.

Experience

- [2 to 5] years of experience in materials management, inventory control, or supply chain within a GMP-regulated pharmaceutical, biotech, or CDMO manufacturing environment.
- Prior experience with SAP systems strongly preferred.
- Experience supporting multi-client/multi-program manufacturing environments (CDMO/CMO) a plus.

Knowledge, Skills & Abilities

- Working knowledge of cGMP requirement, and general familiarity with ICH Q7/Q10 as applied to material management.
- Understanding of material lifecycle in a biopharma manufacturing setting: procurement, and disposition.
- Proficiency in SAP transactions, Microsoft Excel, and general office software.
- Solid attention to detail and accuracy in documentation and inventory transactions.
- Effective written and verbal communication skills; ability to interface with vendors, internal cross-functional teams, and client representatives.

📌 Material Management Specialist( Biologics) Executive/ Senior Executive (Bengaluru)
🏢 Kemwell
📍 Bengaluru