We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
We are seeking a highly motivated individual to join us as a Manager, Site Quality Logistics & Stability in our Contract Manufacturing site located in Research Triangle Park, NC. This role will be a hands-on resource reporting to the Director of Quality Control and must be able to manage risk and apply appropriate tools to assure compliant resolution stability and sample logistics challenges.
Primary responsibilities will be to manage and coordinate personnel performing a combination of sample management and stability oversight supporting laboratory testing, stability testing, raw materials testing, reference material and critical reagent inventories, and sample handling including receipt, tracking, maintenance, shipment and disposal of samples. The incumbent is responsible for day-to-day management of the Quality Logistics & Stability as a center of excellence and is responsible for hiring, managing performance, and development of reporting staff.
Essential Functions and Duties:
Responsible for the strategy and direction of the Logistics and Stability group, which includes:
- Leading a team that receives and organizes in-process and Drug Substance samples from the manufacturing process for routine, non-routine, and stability testing.
- Provides expertise on interpretation of regulatory guidelines that govern the stability storage and testing of biologicals adhere to regulatory requirements such as cGMPs, and ICH.
- Coordinates the creation, revision, and closure of stability protocols including LIMS builds
- Ensures the development, implementation and execution of effective processes for local sample handling procedures, retain and reserve sample collection and storage.
- Defines departmental roles and accountabilities, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
- Establishes and communicates performance objectives for Stability and Sample Management staff that are consistent with the businesses unit goals, and site Quality objectives.
- Monitor stability equipment and coordinate with other groups to ensure all equipment is maintained in a calibrated and qualified state.
- Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.
- Ensures that all Stability and Sample Management personnel are provided adequate training, education and experience to perform their GMP related job function effectively.
- Verifies compliance with applicable Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
- Participates in compliance related teams working towards the goal of continuous improvement.
- Participates in the site team, which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
- Independently maintain sample inventory/disposition database including reconciling inventories.
Minimum Education Requirements
- BS/BA in Industrial Engineering or in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field
- 8+ years related (4 years required with relevant MS degree) in pharmaceutical or biotechnology industry with an emphasis in laboratory operations coordination or related field
Specific Skills and Competencies
- Familiarity with software applications such as Trackwise, Labware LIMS, and FreezerPro.
- Capable of identifying, escalating, and resolving problems
- Capable of managing multiple tasks in a manner that promotes effective schedule adherence.
- Ability to manage changing priorities in a productive and positive manner
- Ability to communicate effectively with colleagues in department, building trust and respect
- Ability to learn and incorporate lean lab and six sigma principles into daily work environment.
- Problem solving and troubleshooting competencies
- Able to make informed and timely decisions independently
- Ability to contribute beyond own product/department
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.