Associate Director of GMP Manufacturing Operations

We are seeking an experienced and dynamic Associate Director of Operations to lead and oversee all aspects of our client's GMP manufacturing operations, including internal production function and overtime, third-party manufacturing partners. The Associate Director of Operations will be responsible for ensuring efficient, high-quality, and cost-effective production processes that align with the company’s strategic goals. This role requires a strong leader with exceptional organizational, operational, and interpersonal skills to drive operational excellence and foster collaboration between internal teams and external partners.

Key Responsibilities:

Strategic Leadership:

• Develop and implement manufacturing strategies that support the company’s growth objectives, operational efficiency, and cost management.
• Define and execute a roadmap for scaling production capabilities across internal and external manufacturing operations.

Internal Manufacturing Operations:

• Oversee day-to-day operations of internal manufacturing facilities, ensuring adherence to production schedules, quality standards, and safety protocols.
• Identify and implement process improvements to increase productivity, reduce waste, and enhance overall efficiency.
• Ensure compliance with regulatory requirements, industry standards, and company policies.

Cross-Functional Collaboration:

• Collaborate with supply chain, procurement, R&D, quality assurance, and other departments to ensure seamless integration between manufacturing and broader business operations.
• Work closely with product development teams to ensure manufacturability and scalability of new product designs.

Team Development & Leadership:

• Build and mentor a high-performing manufacturing team by fostering a culture of accountability, continuous improvement, and innovation.
• Provide coaching, development opportunities, and performance management to ensure team success.

Financial Management:

• Develop and manage budgets for manufacturing operations, ensuring cost-effective use of resources.
• Track and report on key performance indicators (KPIs) related to production efficiency, quality, and cost.

Risk Management:

• Identify and mitigate risks related to production capacity, quality issues, and supply chain disruptions.
• Develop contingency plans to ensure uninterrupted manufacturing operations.

Third-Party Manufacturing Oversight (18-24 months):

• Assess third-party manufacturing partner candidates in partnership with Technical Development and select partner based on business needs.
• Establish and maintain strong relationships with third-party manufacturers to ensure alignment with company expectations for quality, cost, and delivery timelines.
• Negotiate contracts, define performance metrics, and conduct regular reviews to assess partner performance.
• Coordinate with external partners to manage capacity planning, production scheduling, and issue resolution.

Qualifications:

• Bachelor’s degree in engineering, manufacturing, operations management, or a related field; advanced degree (MBA or equivalent) preferred.
• 10+ years of experience in pharma/ biotech GMP manufacturing and 3+ years leading people. Proven track record of managing internal operations and external manufacturing partners.
• In-depth knowledge of manufacturing processes, quality systems, and industry best practices.
• Strong leadership and team management skills with the ability to inspire and develop talent.
• Excellent analytical and problem-solving abilities, with a focus on data-driven decision-making.
• Exceptional communication and negotiation skills, with the ability to influence stakeholders at all levels.
• Proficiency in using manufacturing and supply chain management software/tools.