Job Title:
Location:
Role Summary:
Lead strategic planning for Contract Manufacturing Operations (CMO) aligned with business goals. Identify and onboard CMOs based on capability, compliance, and cost. Develop long-term sourcing and capacity plans for launches and growth. Ensure business continuity and proactively manage risks across external manufacturing operations.
Key Responsibilities:
1. Strategic Leadership & Business Planning
- Develop and implement the long-term strategy for CMO operations in alignment with business objectives.
- Identify, evaluate, and onboard CMOs based on technical capability, capacity, compliance history, and cost competitiveness.
- Establish long-term capacity and sourcing plans to support product launches and market expansion.
- Drive business continuity planning and risk mitigation for external manufacturing operations.
2. Planning, Coordination & Supply Chain Alignment
- Lead end-to-end planning activities for CMO operations including demand planning, supply planning, and material planning.
- Collaborate with Supply Chain, Production Planning, and Procurement teams to ensure accurate demand forecasts and production schedules.
- Oversee allocation of production across CMOs based on capacity utilization, lead times, and cost considerations.
- Ensure alignment between internal planning teams and external CMOs for production timelines, shipment schedules, and inventory management.
- Monitor and review monthly production plans, capacity load, and material availability to ensure uninterrupted supply.
- Coordinate with vendors for timely availability of APIs, excipients, and packaging materials required for CMO batches.
- Review supply chain KPIs such as forecast accuracy, adherence to production plans, and material readiness.
3. Operational Oversight & Execution
- Ensure smooth execution of manufacturing operations at CMOs as per approved plans and timelines.
- Review weekly and monthly production performance against plan and initiate corrective actions where necessary.
- Drive operational excellence through continuous improvement in productivity, yield, and turnaround time.
- Conduct periodic site visits to monitor performance, resolve operational bottlenecks, and enhance process capability.
4. Quality, Compliance & Regulatory Management
- Ensure all CMO facilities operate in full compliance with cGMP and company quality standards.
- Partner with QA/QC and Regulatory teams for audits, product filings, and inspection readiness.
- Oversee quality metrics, deviations, change controls, and CAPA closures in coordination with the Quality team.
- Support CMO sites during regulatory audits (USFDA, EMA, WHO, MHRA, etc.) and ensure continuous compliance readiness.
5. Technical & Process Support
- Collaborate with Technical Services, R&D, and Technology Transfer teams for new product introductions and process validations.
- Provide technical oversight for scale-up, troubleshooting, and optimization of manufacturing processes at CMOs.
- Ensure technical agreements and manufacturing instructions are updated and adhered to.
6. Vendor & Stakeholder Management
- Serve as the primary point of contact for all CMO and vendor interactions.
- Conduct regular business review meetings with CMOs to evaluate performance (Quality, Delivery, Cost, and Compliance).
- Develop strong partnerships with CMO leadership teams to foster transparency and mutual growth.
- Coordinate cross-functionally with internal teams Quality, Regulatory, SCM, Finance, and R&D for seamless execution.
7. Cost & Performance Management
- Manage CMO operational budgets and drive cost optimization through efficiency initiatives and strategic sourcing.
- Monitor and report KPIs: cost per batch, OTIF (On-Time In-Full) delivery, rejection rates, yield, and resource utilization.
- Identify and implement productivity and cost-reduction initiatives across CMOs.
8. People Leadership
- Lead and mentor a team responsible for CMO operations, planning, and coordination.
- Build team capability in vendor management, technical assessment, and production planning.
- Promote a culture of collaboration, accountability, and performance excellence.
Qualifications & Experience:
Education:
B. Pharm / M. Pharm / B.Sc. / M.Sc. / B. Tech (Chemical / Biotech) or equivalent degree in science or pharmacy. MBA preferred.Experience:
10- 15 years in pharmaceutical manufacturing with at least 7 years in CMO operations and business development.Technical Expertise:
- Exposure to multiple dosage forms Injectables (aseptic, lyophilized, BFS) and Oral Solid Dosage forms (tablets, capsules, controlled release).
- Skilled in technology transfer, process validation, scale-up, and capacity management.
- Strong knowledge of planning systems, demand & supply planning, capacity management, and vendor performance monitoring.
- In-depth understanding of GMP, ICH guidelines, and global regulatory submissions (IND, NDA, ANDA) with compliance exposure to USFDA, EMA, WHO, and MHRA.
- Experienced in leading cross-functional, multi-site operations with a focus on efficiency and compliance.
- Proficient in ERP (SAP), MES, LIMS, and digital manufacturing platforms, with strong expertise in supply chain and vendor coordination.
- Proficient in ERP (SAP), MES, LIMS, and digital manufacturing platforms with strong supply chain and vendor coordination skills.
Interested candidate can share CV at ;
bhuvneshwari.rathore@amneal.com
Subject line :
CMO Operation Head
