Post: Senior Manager Contract Manufacturing & Development (CMD)
Job Description
Key Responsibilities and Accountabilities:
Carry Out:
- Planning for manufacturing of Loan License (LL) products & procurement of Third Party (TP) products based on market requirement.
- Maintenance and record availability of commercial product stock.
- Proficiency in handling various soft tools for procurement and inventory management of raw materials, packing materials, and finished products.
- Procurement of materials for manufacturing through purchase orders in soft systems.
- Data entries including material receipt, batchwise consumptions, inventory management, and consumption after batch manufacturing in ERP/SAP or equivalent software.
- Procurement of raw and packaging materials for commercial products.
- Material inventory management as per supply agreements with CMOs & material suppliers.
- Identification of suitable CMOs for commercial manufacturing.
- Liaison with CMOs for manufacturing, remediation, and improvement.
- Calculation of product conversion charges and negotiation with CMOs.
- Preparation and review of commercial manufacturing plan, documents, and execution.
- Management of process validation and compliance with regulatory requirements.
- Technical troubleshooting and implementation of CAPA at manufacturing sites.
- Root cause investigation of product & process failures and implementation of CAPA.
Ensure:
- Control of manufacturing processes for product quality risk assessment.
- Compliance with GxP and Ferring quality standards.
- Timely supply of commercial products.
- Professional relationship management with CMOs and material suppliers.
- Operational excellence for high yield of LL products.
Ensure & Support:
- Coordination with cross-functional teams.
- Support to quality and regulatory team.
- Preparation of supply agreements and relevant documents.
- Training & guidance to CMO personnel.
- Process excellence, continuous improvement, and cost optimization.
Candidate Profile Required at Ferring Pharmaceuticals
- B.Pharm / M.Pharm from a reputed university.
- Minimum 10 years of experience in drug product manufacturing.
- Experience of FDA Approval in various pharmaceutical dosage forms.
- Competent Technical person & Registered Pharmacist.
- Production experience with thorough knowledge of GMP and Pharma regulations.
Desired Candidate Details
- Experience working with CMOs, shop floor experience.
- Understanding of manufacturing troubleshooting, quality, and regulatory requirements.
- Excellent oral/written communication skills.
- Comfortable with travel requirements.
Additional Information
- Experience: 10 years
- Qualification: B.Pharm / M.Pharm
- Location: Mumbai, India
- Industry Type: Pharma/ Healthcare/ Clinical research
- Functional Area: Contract Manufacturing & Development (CMD)
- End Date: 30th May 2024
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