Manager QC Lab Support

The Manager QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry QC Bioassay QC Microbiology etc. and operational excellence. This Manager QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

Leads all areas of QC Lab Support (e.g. change controls investigations corrective action preventive action (CAPAs) data review etc.
Develops QC Lab Support goals and strategy in alignment with the production schedule
Drives Quality Control key performance indicators (KPIs) to support quality continuous improvement while escalating and mitigating issues
Oversees training and development for all QC Lab Support staff
Ownership and oversite of QC systems and business processes
Interacts professionally with clients and partners to effectively communicate QC deliverables and commitments
Leads discussions and responses during inspections including area readiness prior to these inspections
Drives and supports alignment 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 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

Minimum Requirements:

Bachelors 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 Engineering or related science with 3 years of experience
25 years of people management experience
Experience working in a regulated GMP environment
Experience managing and developing direct reports and teams
Extensive experience with Analytical and/or Microbiology methods

Preferred Requirements:

5 years of experience in a GMP environment
Experience working in a contract manufacturing or testing organization
Experience with statistical experimental design and data analysis with JMP software

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods up to 240 minutes.

Ability to sit for prolonged periods up to 240 minutes.

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

Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions pounds.

Will work in small and/or enclosed spaces.

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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .