Manager, QC Lab Support Position Available In Wake, North Carolina

Job Description:

FUJIFILM

Diosynth Biotechnologies is building the future ofbioproduction in Holly Springs, North Carolina. By end of 2025,we’ll open North America’s largest end-to-end CDMObiopharmaceutical manufacturing facility, offering drug substanceproduction, fill-finish, and packaging under one roof. We’relooking for passionate, mission-driven people to help us realizethis exciting vision and deliver the next vaccine, cure, ortherapy. We offer a dynamic work environment and we’re proud tocultivate a culture that will fuel your purpose, energy, anddrive—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 thrivingtech scene, making it the perfect blend of community andopportunity. What Youll Do

• Leads all areas of QC Lab Support(e.g., change controls, investigations, corrective actionpreventive action (CAPAs), data review, etc.)
• Develops QC LabSupport goals and strategy in alignment with the productionschedule
• Drives Quality Control key performance indicators (KPIs)to support quality, continuous improvement, while escalating andmitigating issues
• Oversees training and development for all QCLab Support staff
• Ownership and oversite of QC systems andbusiness processes
• Interacts professionally with clients andpartners to effectively communicate QC deliverables and commitments
• Leads discussions and responses during inspections, includingarea readiness prior to these inspections
• Drives and supportsalignment and coordination between other FDB sites on QC topics
• Manages and develops direct reports from the Lab Support team
• Administers company policies such as time off, shift work, andinclement weather that directly impact employees
• Completesrequired administrative tasks (e.g., timecard approvals, time offapprovals, expense reports etc.)
• Coaches and guides directreports to foster professional development
• Participates in therecruitment process and retention strategies to attract and retaintalent, as needed
• Addresses performance gaps, employee questionsand concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in Chemistry, Microbiology, Biological Sciences,Engineering or related science with 7 years of experience OR
• Masters degree in Chemistry, Microbiology, Biological Sciences,Engineering or related science with 5 years of experience OR
• Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineeringor related science with 3 years of experience
• 2-5 years of peoplemanagement experience
• Experience working in a regulated GMPenvironment
• Experience managing and developing direct reports andteams
• Extensive experience with Analytical and/or

Microbiologymethods Preferred Requirements:

• 5 years of experience in a GMPenvironment
• Experience working in a contract manufacturing ortesting organization
• Experience with statistical experimentaldesign and data analysis with JMP software

Physical and WorkEnvironment Requirements:

• Ability to discern audible cues.
• Ability to stand for prolonged periods up to 240 minutes.
• Abilityto sit for prolonged periods up to 240 minutes.
• Ability toconduct activities using repetitive motions that include wrists,hands and/or fingers.
• Ability to conduct work that includesmoving objects up to 10
• Ability to bend, push or pull, reach toretrieve materials from 18″ to 60″ in height, and use twistingmotions pounds.
• Will work in small and/or enclosed spaces.