Director, Large-Scale Manufacturing
- 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.