Associate Director, Drug Substance Manufacturing

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll 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

• Bachelors 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 Masters degree with 6 years in a similar role within large pharma/biotech.
• 610 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: 48
• Indirect reports: 5070

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 ().

Required Experience:

Director