General Manager, CDMO Operations

BioTalent are currently partnered with a leading Contract Development and Manufacturing Organization (CDMO) specializing in biologics. This organization partners with global biopharmaceutical clients to provide comprehensive solutions for the development, production, and commercialization of biologic drug products. They offer end-to-end services, including process development, clinical and commercial manufacturing, and regulatory support, ensuring the highest quality standards are met. They are currently seeking a highly skilled and dynamic General Manager to oversee their CDMO operations.

Position Overview:

The General Manager (GM) of CDMO Operations will be responsible for overseeing the entire operations of their biologics contract development and manufacturing division. This key leadership position will ensure the delivery of high-quality services to our clients while driving operational excellence, compliance, and business growth. The GM will work closely with cross-functional teams, including manufacturing, quality control, regulatory, and business development, to align strategic objectives and ensure smooth operational execution.

Key Responsibilities:

• Leadership & Strategy: Oversee biologics CDMO operations, developing and implementing strategies to ensure high-quality service delivery and business growth.
• Operational Excellence: Manage daily operations, optimize productivity, and ensure compliance with GMP and regulatory standards.
• Client Relations: Serve as the main client contact, ensuring project success and maintaining long-term relationships.
• Team Management: Lead and develop cross-functional teams, fostering a culture of collaboration, innovation, and accountability.
• Financial & Resource Management: Oversee budgets, track KPIs, and ensure efficient use of resources to meet production demands.
• Regulatory Compliance: Ensure adherence to industry regulations, lead audits and inspections, and maintain up-to-date knowledge of guidelines.

Qualifications:

• Bachelor's or Master’s degree in Life Sciences, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 10 years of experience in biologics manufacturing or contract development and manufacturing, with at least 5 years in a senior leadership or general management role.
• Strong knowledge of biologics manufacturing processes, GMP, and regulatory requirements for biologics (e.g., cell and gene therapies, monoclonal antibodies, vaccines).
• Proven experience in managing large-scale biologics manufacturing operations, including capacity planning, process optimization, and cost management.
• Experience in managing client relationships, project management, and overseeing cross-functional teams.
• Strong financial acumen with experience in budgeting, resource allocation, and cost control.
• Exceptional leadership, communication, and interpersonal skills, with the ability to influence and build relationships at all levels.
• Experience in working with regulatory agencies and managing audits and inspections.

If this is of interest, please reach out to me on nikhil.akkoo@biotalent.com