This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
Company OverviewFUJIFILM Diosynth 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
What You’ll Do
Project Phase (Through Mid-2025)
Supports Factory Acceptance Testing (FAT) at the vendor site as required Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicablePerforms other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employeesOperations Phase (Starting Mid-2025)
Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training Supports manufacturing investigations and continuous improvement projects Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipmentAdministers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employeesPerforms other job as assignedWho You Are
You have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area. You have an understanding of manufacturing run cadence and order of shift activities. You have expertise in cGMP, safety and FDBN operational procedures. You have a strong cross functional partnership with Quality, Process Sciences, Process Engineering and others. You are able to create and maintain a collaborative and inclusive team. You have the ability to travel and have a valid passport.
Basic Requirements
High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects
Preferred Requirements
BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects ORAssociates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects ORMilitary Experience of equivalenceExperience in manufacturing of biological products, familiar with GMP/GLP requirementsPrevious experience leading, supervising or managing others
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in an environment which may necessitate respiratory protectionMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation programAbility to discern audible cuesWORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of time Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.Ability to conduct work that includes moving objects up to 33 lbs.ENVIRONMENTAL CONDITIONS
Will work in heights greater than 4 feetTo 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.
EEO InformationFujifilm 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.
ADA InformationIf 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).
Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Application FAQsSoftware Powered by iCIMS
www.icims.com