FUJIFILM Holdings America Corporation
Director, Drug Substance Manufacturing (DSM)
FUJIFILM Holdings America Corporation, Holly Springs, North Carolina, United States, 27540
Position Overview
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 Administration (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
#J-18808-Ljbffr
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 Administration (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
#J-18808-Ljbffr