Director, Drug Substance Manufacturing (DSM)
Company: Fujifilm
Location: Holly Springs
Posted on: November 29, 2025
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Job Description:
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. 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
Keywords: Fujifilm, Cary , Director, Drug Substance Manufacturing (DSM), Engineering , Holly Springs, North Carolina
