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Director, Large-Scale Manufacturing
- Negotiable
- Gaithersburg, Maryland
- Permanent
This is a standout opportunity for a senior manufacturing leader to take ownership of large-scale drug substance production for a pioneering biopharmaceutical company. With a strong pipeline and a focus on biologics, the organisation is investing heavily in its manufacturing capabilities to meet growing global demand for life-changing therapies.
This position offers both strategic and operational scope, leading multi-disciplinary teams across upstream and downstream manufacturing. The company's mission is to redefine how medicines are made and delivered-balancing speed, quality, and innovation. With a culture rooted in collaboration, continuous improvement, and patient impact, this is a chance to play a key role in shaping the future of biologics manufacturing.
Your role as Director of Large-Scale Manufacturing
Lead day-to-day operations for large-scale drug substance manufacturing, ensuring safety, quality, and output targets are met.
Develop and implement long-term strategies to drive efficiency, productivity, and cost-effectiveness across manufacturing processes.
Oversee all stages of production, from material preparation and cell culture through to bulk drug substance.
Lead, develop, and mentor cross-functional teams-promoting a culture of innovation, accountability, and high performance.
Establish KPIs and use data to drive continuous improvement initiatives and operational excellence.
Set and manage departmental budgets, ensuring optimal use of personnel, materials, and equipment.
Act as the primary point of contact for internal and external partners on manufacturing-related matters.
Participate in audits and inspections, ensuring all operations comply with cGMP, FDA, and internal quality standards.
Collaborate cross-functionally with Quality, Supply Chain, and Technical Services to support commercial and clinical production goals.
Drive site-wide process innovation by adopting digital tools and lean methodologies.
Experience and qualifications for the Director of Large-Scale Manufacturing role
10+ years of leadership experience in biopharmaceutical manufacturing, with strong knowledge of drug substance operations.
Deep understanding of upstream, downstream, and central services within a GMP-regulated environment.
Proven ability to lead diverse teams across complex manufacturing operations.
Strong grasp of regulatory requirements including cGMP and FDA expectations.
Demonstrated success in managing departmental budgets and driving cost efficiencies.
Experience leading or participating in inspections and audits.
Exceptional problem-solving, influencing, and change management skills.
Bachelor's degree (or equivalent) in life sciences, biochemical/chemical engineering, or related field. Advanced degree preferred.
Experience implementing Lean Manufacturing or Six Sigma methodologies is a plus.
Familiarity with digital tools that enhance manufacturing performance is desirable.
Perks and benefits
Competitive compensation package, including bonus potential and long-term incentives.
Flexible hybrid working model (minimum 3 days per week onsite).
Comprehensive health and wellness coverage.
Generous annual leave and paid holidays.
Career development support in a culture that values learning and leadership.
Opportunity to influence the future of biologics manufacturing at scale.
If you're an experienced manufacturing leader looking to make a real impact in the biologics space, apply now for immediate consideration. Alternatively, reach out directly to explore other senior manufacturing opportunities in the life sciences sector.
