Associate Director, Drug Substance Manufacturing

FUJIFILM; Holly Springs (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks an Associate Director, DSM to lead a defined operations area, align teams, and ensure cGMP, regulatory readiness, and budget targets are met. You will develop frontline leaders, drive performance, and coordinate cross-functional priorities in a dynamic, project-driven environment.

You will manage KPIs, implement improvements, and foster safety and inclusion while partnering with Quality, Engineering, Supply Chain, and Process Sciences to deliver

Qualifications

• Bachelor’s degree (BA/BS) in a related field and 8+ years of biotech/pharma experience, including prior people leadership (managing and developing teams).
• BA/BS in Life Sciences or Engineering; or Master’s degree with 6+ years in a similar role within large pharma/biotech.
• 6–10 years in pharmaceutical/biological manufacturing operations.
• Experience leading leaders (managers/supervisors) in a changing, project-driven environment.
• Direct experience with regulatory inspections, investigations, change control, KPIs, and operational budgeting.

Responsibilities

• Lead area operations to achieve production goals with rigorous execution, right-first-time performance, and schedule adherence.
• Translate site objectives into clear goals; communicate vision across multiple levels and ensure alignment with Quality, Engineering, Supply Chain, and Process Sciences.
• Own area KPIs and budget; track performance, forecast needs, and implement corrective and preventive actions to meet targets.
• Govern process changes and documentation to maintain cGMP compliance; champion inspection readiness and lead regulatory inspections for the function.
• Develop supervisors and associate managers; build succession pipelines, coach performance, and foster a culture of safety, inclusion, and continuous improvement.
• Partner with support groups to remove bottlenecks, resolve deviations, drive investigations, and implement change management effectively.
• Represent Manufacturing in client interactions; support day-to-day coordination, scope discussions, and progress reviews.
• Execute other duties as assigned to support a dynamic, project-driven operation.

Skills

People leadership

Regulatory inspections

Cross-functional collaboration

Budget management

Process improvement

Education

Bachelor’s degree in related field

Master’s degree (preferred)

Job description

Position Overview

Help deliver reliable, compliant biomanufacturing at scale. The Associate Director, DSM establishes and leads operations for a defined functional area, aligning people, processes, and systems to meet delivery, compliance, and financial objectives. The role drives production performance and regulatory readiness, develops frontline leaders, partners cross-functionally to meet targets, and owns area KPIs and budget.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Lead area operations to achieve production goals with rigorous execution, right-first-time performance, and schedule adherence.
• Translate site objectives into clear goals; communicate vision across multiple levels and ensure alignment with Quality, Engineering, Supply Chain, and Process Sciences.
• Own area KPIs and budget; track performance, forecast needs, and implement corrective and preventive actions to meet targets.
• Govern process changes and documentation to maintain cGMP compliance; champion inspection readiness and lead regulatory inspections for the function.
• Develop supervisors and associate managers; build succession pipelines, coach performance, and foster a culture of safety, inclusion, and continuous improvement.
• Partner with support groups to remove bottlenecks, resolve deviations, drive investigations, and implement change management effectively.
• Represent Manufacturing in client interactions; support day-to-day coordination, scope discussions, and progress reviews.
• Execute other duties as assigned to support a dynamic, project-driven operation.

Minimum Qualifications

• Bachelor’s degree (BA/BS) in a related field and 8+ years of biotech/pharma experience, including prior people leadership (managing and developing teams).

Preferred Qualifications

• BA/BS in Life Sciences or Engineering; or Master’s degree with 6+ years in a similar role within large pharma/biotech.
• 6–10 years in pharmaceutical/biological manufacturing operations.
• Experience leading leaders (managers/supervisors) in a changing, project-driven environment.
• Direct experience with regulatory inspections, investigations, change control, KPIs, and operational budgeting.

Knowledge, Skills, and Abilities

• Deep understanding of cGMPs, inspection expectations, EHS, and end-to-end manufacturing operations.
• Strength in conceptual problem solving; able to set methods, techniques, and criteria with limited precedent.
• Proven capability to influence and negotiate outcomes with cross-functional and client stakeholders.
• Strong organizational and project management skills; continuous improvement mindset.
• Ability to coach and develop leaders; build accountable, high-performing teams.

Job Scope Factors

• Complexity & Problem Solving: Solves ambiguous, multi-factor problems; implements policy and determines methods/criteria; drives multi-area projects and strategy execution.
• Discretion & Impact: Decisions directly affect short-term (<1 year) results; erroneous decisions may cause critical delays or jeopardize operations.
• Collaboration & Interaction: Interfaces regularly with senior and lower management across functions and with customers; persuades in sensitive, complex situations.
• Management & Supervision: Manages a department or multiple disciplines; oversees experienced professionals and/or subordinate managers; advises teams on moderately complex matters.

Reporting Structure

• Direct reports: 4–8
• Indirect reports: 50–70

Physical Requirements and Working Environment

• May require respiratory protection; may work in mechanical/production areas requiring hearing protection.
• Requires ability to discern audible cues.
• Ability to climb ladders/ramps; stand/sit for prolonged periods; perform repetitive motions of wrists/hands/fingers.
• May lift/move up to 10 lbs; bending, pushing/pulling, and reaching from 18” to 60” required.
• No routine operation of motor vehicles or powered industrial trucks.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).