Hiring: Senior Manager/Associate Director, Drug Substance MSAT Company: FUJIFILM Biotechnologies Location: Holly Springs, NC Job Posted Time: 2026-09-11 13:35:13 Target Skills & Keywords : REST About the job Experience: •8+ years of people management/leadership experience •9+ years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and Good Manufacturing Practices (GMP) •12+ years of experience in similar role with large projects from conceptual design phase to operations •8+ years of experience leading technical departments Required Skills: •Assigns and coaches upstream/downstream scientists, engineers, and team members; directs upstream/downstream technical leads for TT execution and readiness activities; reviews performance and concerns, partners with HR as needed for resolution •Owns product and process stewardship by leading end to end technical strategy execution for assigned products in the suite from new product introduction through commercialization, covering upstream (seed/production bioreactors) and downstream (purification trains) •Sets direction in defining and maintaining the process control strategy by translating product critical quality attributes into upstream/downstream critical process parameters, acceptable ranges, and control plans •Ensures process flow diagram, change controls, and associated documents remain current •Ensures floor presence, safety, and compliance as well as successful manufacturing process comparability and validation runs •Drives continuous improvement projects to improve manufacturability, reliability, efficiency, quality, cost, and compliance •Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data (within batch and batch-to-batch) •Promotes professional development, psychological safety, accountability, personal ownership, and proactive problem-solving; runs effective tier huddles; recognizes contributions and shares learnings (Yokoten) Qualifications: •Master’s degree in an Engineering or Scientific field with 9+ years of experience OR Bachelor’s degree in an Engineering or Scientific field with 11+ years of experience •Technical leadership experience with drug substance manufacturing facilities •Prior drug substance development and manufacturing experience including process validation, process transfer, commercialization, manufacturing support, and troubleshooting drug substance operations •Fujifilm is committed to 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. •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 (FDBN_PNC@fujifilm.com). •9+ years of experience OR Bachelor’s degree in an Engineering or Scientific field with 11+ years of experience Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!