Director, Large-Scale Manufacturing

SEC Life Sciences; Maryland; On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Competitive base salary with performance-related bonuses

Generous benefits package

Supportive environment for career development

Access to cutting-edge science

Job summary

A leading biopharmaceutical organization is seeking a Director of Large-Scale Manufacturing to shape drug substance production. The role focuses on operational strategy and cross-functional collaboration, ensuring compliance and driving efficiency in clinical and commercial manufacturing. Ideal candidates will have over 10 years of leadership experience in biopharmaceutical manufacturing, strong technical skills, and a proven track record in large-scale operations. This role offers a competitive salary, generous benefits, and the opportunity to impact lives through innovative therapies.

Qualifications

• 10+ years in biopharmaceutical or life sciences manufacturing leadership.
• Strong understanding of upstream and downstream operations.
• Experience leading large-scale production teams.

Responsibilities

• Set and deliver long-term manufacturing strategies.
• Lead multidisciplinary teams in drug substance operations.
• Ensure compliance with regulatory standards.

Skills

Leadership in biopharmaceutical manufacturing

Compliance with cGMP standards

Problem-solving

Strategic planning

Team management

Education

Advanced degree in biochemical engineering or related field

Tools

Lean Manufacturing

Six Sigma methodologies

Job description

Director of Large-Scale Manufacturing

A leading biopharmaceutical organization is seeking a senior leader to shape and scale its drug substance production function. The role focuses on operational strategy, process excellence, and cross‑functional collaboration to deliver clinical and commercial manufacturing solutions aligned with the company’s mission to improve lives through innovative therapies.

Responsibilities

• Set and deliver long‑term manufacturing strategies aligned with organizational goals.
• Lead multidisciplinary teams in drug substance manufacturing operations.
• Oversee production processes including material preparation, cell culture, and bulk manufacturing.
• Own department KPIs and operational targets, optimizing for efficiency, cost, and quality.
• Ensure compliance with cGMP and all relevant regulatory standards and serve as a manufacturing lead during inspections and audits.
• Drive a culture of safety, quality, and continuous improvement.
• Partner 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.

Qualifications

• 10+ years of progressive leadership experience in biopharmaceutical or life sciences manufacturing.
• Strong technical knowledge across upstream, downstream, and support operations.
• Proven success managing large‑scale production teams and complex workflows.
• Deep understanding of cGMP standards, regulatory compliance, and quality systems.
• Experience in strategic planning, budget management, and performance monitoring.
• Strong people leadership skills focused 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.

Benefits

• Competitive base salary with performance‑related bonuses.
• Generous benefits package including health, retirement, and annual leave.
• Opportunity to make a measurable impact in a growing, mission‑driven organization.
• Supportive environment with a focus on career development and learning.
• Access to cutting‑edge science and next‑generation manufacturing platforms.

Apply

If you are 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.