Director, Large-Scale Manufacturing

PR/156601_1762183889
  • Negotiable
  • Gaithersburg, Maryland
  • Permanent

A leading biopharmaceutical organisation is seeking a Director of Large-Scale Manufacturing to drive operational strategy and excellence across its drug substance production function. This is a rare opportunity to take ownership of high-impact operations in a technically complex, fast-paced environment focused on improving lives through innovative therapies.

With a strong pipeline and a culture that values integrity, collaboration, and performance, the company plays a vital role in delivering clinical and commercial manufacturing solutions. Their mission is grounded in science and executed through best-in-class manufacturing processes. Now, they're looking for a senior leader to shape and scale this vital part of their business.

Your role as Director of Large-Scale Manufacturing

  • Set and deliver long-term manufacturing strategies that align with organisational goals

  • Lead multi-disciplinary teams responsible for drug substance manufacturing operations

  • Oversee production processes including material prep, cell culture, and bulk manufacturing

  • Own department KPIs and operational targets, optimising for efficiency, cost, and quality

  • Ensure consistent compliance with cGMP and all relevant regulatory standards

  • Act as the manufacturing lead during regulatory inspections and internal audits

  • Drive a culture of safety, quality, and continuous improvement across all functions

  • Partner cross-functionally with Quality, Supply Chain, and Engineering teams to resolve issues and implement process improvements

  • Guide development of site-wide production plans to meet commercial and clinical demand

  • Lead CAPEX and OPEX planning, including budget management and resource allocation

  • Stay ahead of industry trends to recommend and implement innovative manufacturing solutions

Experience and qualifications for the Director of Large-Scale Manufacturing role

  • 10+ years of progressive leadership experience in biopharmaceutical or life sciences manufacturing

  • Strong technical knowledge across upstream, downstream, and support operations

  • Demonstrated success managing large-scale production teams and complex workflows

  • Deep understanding of cGMP standards, regulatory compliance, and quality systems

  • Proven experience in strategic planning, budget management, and performance monitoring

  • Strong people leadership skills with a focus on mentorship, accountability, and collaboration

  • Comfortable leading through change and influencing at senior levels

  • Excellent problem-solving, decision-making, and communication skills

Preferred:

  • Advanced degree in biochemical engineering, life sciences, or related field

  • 15+ years of experience in biologics manufacturing leadership roles

  • Familiarity with Lean Manufacturing or Six Sigma methodologies

  • Experience with digital transformation or smart manufacturing tools

Perks and benefits

  • Opportunity to make a measurable impact in a growing and mission-driven organisation

  • Lead a high-performing team in a key strategic role

  • Competitive base salary with performance-related bonuses

  • Generous benefits package including health, retirement, and annual leave

  • Supportive environment with a focus on career development and learning

  • Exposure to cutting-edge science and next-generation manufacturing platforms

If you're an experienced manufacturing leader ready to take the next step in your career, apply now for immediate consideration. Alternatively, reach out to discuss similar opportunities in the biopharmaceutical manufacturing space.

Riya Sharma Consultant

Apply for this role

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