Head - CDMO | Indian Pharma Start-Up | Mumbai

About Our Client

Our client is leading business and investment house, actively investing in a diverse range of ventures across multiple industries.

Job Description

The key responsibilities include :

1. CDMO Strategy and Vendor Management :

• Identify and evaluate potential CDMOs : Research and establish partnerships with contract manufacturers capable of meeting production requirements for generics.
• Evaluate performance : Regularly assess the CDMO's performance to ensure they meet quality standards, timelines, and cost targets.

2. Regulatory Compliance and Quality Assurance :

• Work with regulatory affairs : Collaborate with the regulatory team to ensure that the product manufactured by the CDMO complies with national and international regulations (, CDSCO, USFDA, EMA).
• Compliance audits : Conduct regular audits and inspections at the CDMO sites to ensure manufacturing practices align with regulatory and company standards.
• Ensure product registration : Support the regulatory team in product filings and ensuring that manufacturing sites are registered with the relevant authorities.

3. Supply Chain and Logistics Management :

• Supply chain optimization : Identify opportunities to improve supply chain efficiency, reduce lead times, and ensure timely deliveries from CDMOs.
• Cross-department collaboration : Work closely with R&D, regulatory, marketing, and logistics teams to ensure smooth coordination and timely delivery of products.
• Identify and mitigate risks : Proactively manage potential risks related to outsourcing production, including regulatory risks, quality risks, and supply chain disruptions.

The Successful Applicant

The ideal candidate would have :

• Bachelor's / Master's degree or MBA in Operations Management, Pharmaceutical Management, or Supply Chain (preferred).
• Minimum 15 years of experience in the pharmaceutical industry, with a proven track record of working with CDMOs and managing outsourced manufacturing operations.
• Hands-on experience with GMP, regulatory compliance, and quality control in pharma manufacturing.
• Ability to lead cross-functional teams and manage multiple stakeholders and build systems and processes from the ground up.
• High attention to detail and a commitment to ensuring compliance and quality at all stages of the production process.