Director, Drug Substance Manufacturing (DSM)

Director, Drug Substance Manufacturing

The Director, Drug Substance Manufacturing (DSM) plays a critical role in the design, execution, and leadership of DSM Operations strategy for the Holly Springs site. This role is accountable for all upstream and downstream manufacturing operations, ensuring safe, compliant, and successful delivery of life changing therapies for patients. The Director, DSM guides leaders, develops high-performing teams, and works cross-functionally to ensure alignment with our global network, including our partner site in Denmark. This role influences the long-term success of our site and partners with top-tier biopharmaceutical companies to manufacture cutting-edge medicines that change lives.

Job Description

What You'll Do

Develops and implements end-to-end DSM operational strategy, covering both Upstream (e.g., Media Prep, Seed Train, Production Bioreactor) and Downstream (e.g., Buffer Prep / Hold, Chromatography, Viral Filtration, UFDF) manufacturing

Leads, coaches, and empowers leaders and teams to build an efficient, diverse, and solution-driven DSM organization

Ensures safe, compliant, and reliable operations while meeting production goals and client commitments

Fosters a culture of continuous improvement to optimize manufacturing processes, systems, and operational readiness

Establishes and oversees DSM escalation flow for technical, quality, and safety issues

Manages departmental budget, including resource planning, operational expenses, and capital expansion projects

Drives collaboration and alignment across cross-functional teams including Quality, Supply Chain, Engineering, Process Sciences, and Program Management

Ensures all DSM operations are conducted in compliance with current good manufacturing practice (CGMP), Food and Drug Administration (FDA), Occupational Safety and Health Association (OSHA), environmental, labor, and industrial health regulations

Partners with clients and stakeholders, supporting commercial development, proposals, and scope-of-work reviews

Serves as primary liaison to clients for DSM activities, including participation in presentations and site visits

Develops and maintains manufacturing schedules, including personnel and equipment requirements, to support a 24 / 7 manufacturing operation

Identifies and mitigates risks related to quality, safety, and operational reliability

Manages and develops direct reports from Manufacturing team

Administers company policies such as time off, shift work, and inclement weather that directly impact employees

Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)

Coaches and guides direct reports to foster professional development

Participates in the recruitment process and retention strategies to attract and retain talent, as needed

Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution

Performs other duties, as assigned

Basic Requirements

Master's degree in scientific or engineering field with 11+ years of experience; OR Bachelor's degree in scientific or engineering field with 13+ years of experience; OR Associate's degree in scientific or engineering field with 15+ years of experience; OR High school diploma with 17+ years of experience

5+ years of people management, leadership & team management experience

Proven experience in both Upstream and Downstream large-scale biologics manufacturing operations.

Preferred Requirements

Master's degree in scientific or engineering field

10+ years of people management, leadership & team management experience

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and / or fingers
• Ability to conduct work that includes moving objects up to 10 pounds