Senior Manager Contract Manufacturing & Development (CMD)

Experience:

Minimum 10 years of experience in drug product manufacturing / Production of oral dosage form and sterile products

Experience of FDA Approval in the Production/ Manufacturing area (Various Pharmaceuticals Dosage forms)

Should be Competent Technical person & Registered Pharmacist

Should have Production experience, thorough knowledge about GMP with awareness about Pharma regulations.

Qualification: B.Pharm / M.Pharm from reputed university

Key Responsibilities and accountabilities: Following responsibilities include, but not limited to:

Carry out: Planning for manufacturing of Loan License (LL) products & procurement of Third Party (TP) products based on market requirement To carry out commercial product stock maintenance and records availability. Skills for handling various soft tools for procurement and inventory management of all raw materials, packing materials and finished products.

Procurement of materials for manufacturing by generating purchase orders in the soft systems

Various entries of materials including material receipt, batchwise consumptions of the materials, inventory of materials, consumption of materials after batch manufacturing in the ERP/SAP or equivalent software of inventory management

Procurement of raw and packaging materials for manufacturing of commercial products and maintain the material inventory management (inward and consumption) as per supply agreement with CMOs & material suppliers Identify suitable CMOs for commercial manufacturing based on quality audit and as per Ferring s selection matrix and liaise with CMOs for commercial manufacturing, remediation & improvement Calculation of product s conversion charges and participate in negotiation with CMOs

To prepare and review commercial manufacturing plan, documents & execution at manufacturing site

Manage process validation for new and on-going products across manufacturing plants and ensure compliance with current regulatory requirements

Technical troubleshooting and implementation of robust CAPA at manufacturing site Carry out root cause investigation of product & process failures and implement CAPA

Ensure:

Ensure products are in control in terms of manufacturing processes (CQAs, CMAs and CPP) to confirm product s quality risk assessment & product robustness prior to commercial manufacturing Ensure commercial manufacturing in compliance with GxP and Ferring quality standards Timely supply of commercial products as per business requirement to prevent short supply to market and sales loss

Exhibit professional relationship with CMOs (TP products supplier & LL products manufacturers) and material suppliers

Operational excellence to achieve high yield of LL products as per Ferring quality standards

Ensure & Support:

To co-ordinate with cross functional teams like site manufacturing team (Production, QA, QC), Regulatory, Supply chain, Sourcing team to meet business priorities

Coordinate with quality and regulatory team to provide relevant documents to get commercial manufacturing license and support to regulatory queries

 Preparation of Supply Agreement with the CMOs & materials suppliers

Create product & material code for new product launch activities as per Ferring system and coordinate with Late-stage CMC Relevant manufacturing documents preparation to support commercial manufacturing at CMO site

To support Quality in preparation of Quality Technical Agreement (QTA)

To provide necessary training & guidance to CMO personnel with respect to commercial batch manufacturing as per GxP

Organize process excellence, continuous improvement to simplify manufacturing process and enhance productivity

To drive and implement cost optimization program for existing commercial products

Desired Candidate details:

Should have good experience of working with CMOs, shop floor experience

Should have good understanding of manufacturing trouble shooting, Quality, regulatory requirements for filing the product

Excellent oral / written communication skills - allowing effective interactions with all levels of the organization

Should be comfortable with travelling, as per the requirement of the deliverables

Full time