Lead Contract Manufacturing Operations - (API)

Job Description

Job description for the role of Lead of API CMO

"Macleods Pharmaceuticals Limited"
Company Overview: A vertically integrated, Global Pharmaceutical Company.
Established in 1989, we are engaged in developing, manufacturing, and marketing a wide range of formulations across several major therapeutic areas including anti-infective, cardiovascular, anti-diabetic, dermatology, and hormone treatment.
We develop, manufacture, and globally distribute a broad range of pharmaceutical products across therapies in multiple dosage forms such as solid orals, liquid orals, topical formulations, injectable (Dry Powder) metered dose inhalers and dry powder inhalers.

Job Summary:-

• The Lead of API CMO will be responsible for the strategic and operational leadership of all outsourced Active Pharmaceutical Ingredient manufacturing activities. This role eill ensure that CMO partners deliver APIs safely, compliantly, on time, and at the right cost and quality standards. The incumbent will act as the primary interface between the company and its external manufacturing partners, managing the lifecycle of API sourcing, tech transfer, commercial production, and contract compliance.

Key Responsibilities
A) Strategic Sourcing & Network Management

• Develop and execute the external API manufacturing strategy to support portfolio needs.
• Identify, evaluate, and select new CMO sites for NCEs (New Chemical Entities) and Generic API products.
• Establish long-term partnerships and build strategic alliances to expand company capabilities.

B) Operational Excellence & Project Management

• Oversee end-to-end API project delivery, including tech transfer, process validation, scale-up, and commercial launch readiness.
• Ensure on-time, in-full (OTIF) delivery of APIs by managing production planning and inventory strategies with CMOs.
• Lead routine production support, monitoring yield, process efficiency, and cost reductions (COGS).

C) Quality and Regulatory Compliance

• Partner with Quality Assurance to ensure CMOs operate in full compliance with cGMP, ICH, FDA, EMA, and other local/global regulatory standards.
• Oversee the management of Quality Technical Agreements (QTA), change controls, deviations, CAPAs, and market complaints.
• Lead audit teams and ensure readiness for regulatory inspections.

D) Commercial and Contract Management

• Negotiate commercial terms, MOQs (Minimum Order Quantities), and price agreements in partnership with Procurement.
• Own P&L responsibilities for the external API business unit, focusing on cost-effective manufacturing.

E) Technical Support & Risk Management

• Provide technical stewardship to ensure process robustness (reaction, crystallization, filtration, drying).
• Perform risk assessments and develop contingency plans for supply chain disruptions.

Required Qualifications:-

• Education: Bachelors or Masters degree in Chemical Engineering, Chemistry, or Pharmaceutical Sciences. A PhD or MBA is a plus.
• Experience: Minimum 1520+ years in the pharmaceutical industry, with at least 510 years in senior leadership roles directly managing API external manufacturing (CMO/CDMO).
• Regulatory Knowledge: Deep understanding of cGMP and regulatory guidelines (FDA, EMA) for API production.

Required Skills:-

• Strategic Vision: Ability to shape external manufacturing networks and anticipate industry risks.
• Leadership & Influence: Proven ability to lead without authority and manage complex stakeholder environments.
• Technical Depth: Solid grasp of API manufacturing processes and technology transfer.
• Negotiation & Business Acumen: Skilled in commercial negotiations and contract management.
• Data-driven Decision Making: Proficient in managing KPIs for performance metrics.

Performance Indicators (KPIs):-

• Percentage of On-Time In-Full (OTIF) deliveries.
• Quality compliance rate (number of deviations, CAPAs, audit observations).
• API yield and process efficiency improvement.
• Cost of Goods Sold (COGS) reduction targets.

How to apply:
Interested candidates can share their updated resume at swapneel.wadkar@macleodspharma.com / WhatsApp their resumes on +91-9004751112. Candidates meeting the expectations of the requirement will only be contacted. You can also share / refer this position to the applicants who are seeking job opportunities and meeting the required criteria.

Thanks & Regards,
Swapneel .S. Wadkar
Talent Acquisition - | human Resources Dept |
Macleods Pharmaceuticals Ltd

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