"Alerted.org

Position Overview

The Director, Drug Substance Manufacturing (DSM) plays a critical role in the design, execution, and leadership of DSM Operations strategy for the HollySprings 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 alignmentwith our global network, including our partner site in Denmark. This role influences the long-term success of our site and partners with top-tierbiopharmaceutical 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

_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _3 days ago_ _(9/9/2025 8:59 AM)_

**_Requisition ID_** _2025-35559_

**_Category_** _Manufacturing_

**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_