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.
The Quality Control Planner position assists laboratory management with the coordination of resources and assignment of activities within the Quality Control Laboratory. This position schedules activities, identifies resource constraints, provides utilization metrics, and provides workload forecasts. This position coordinates with analysts and area management to assure laboratory readiness to support all incoming testing. The position may also support other laboratory activities as required.
Other duties and responsibilities include:
- Creates and manages detailed schedule for all necessary QC laboratory functions such as training, testing, data review, pink cards investigation, laboratory investigations, CAPAs, periodic SOP review, Test Method review, Batch Record review and all other routine laboratory operations using appropriate software.
- Coordinates with Manufacturing, Facilities Engineering, Validation, Process Sciences and other departments, as required, to ensure other ancillary activities such as plant shut-downs and validation activities testing support are reflected in testing schedules.
- Works with QC Director, Managers and Supervisors to resolve schedule conflicts, develop and implement work-around strategies and tactical alternatives.
- Assesses resource capacity (Personnel, equipment and lab space) on a weekly, monthly and quarterly basis.
- Coordinates or assists in resolving laboratory or sample-related issues
- Ensures sufficient laboratory supplies are maintained to complete testing on time.
- Monitor declined and overdue assignments and summarizes barriers to operations along with proposed solutions.
- Support monthly staffing reporting and tracking of actual versus planned resources and maintain a staffing forecast.
- Keep utilization metrics up to date and visible
- Reviews blanket orders to ensure adequate quantities are ordered without waste.
- Monitors VMI inventory and may add additional materials for autostock and periodically evaluate minimums and maximum quantities.
- All other duties as assigned.
Minimum Education Requirements
- BS/MS in relevant Science or Engineering discipline, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field
- 5+ years of experience in a laboratory cGMP pharmaceutical environment, including 2 years scheduling laboratory activities.
Specific Skills and Competencies
- Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
- Experience in SmartQC, LabWare LIMS and TrackWise systems preferred.
- Ability to coordinate, facilitate and organize resources.
- Ability to develop strategic relationships; strong verbal and written communication skills.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work effectively under extreme pressure to meet deadlines.
- Strong organizational skills with the ability to handle multiple competing priorities.
- Proven success in leading complex projects and bringing them to conclusion.
- Ability to persuasively champion strategic ideas, as supported by sound rationale and analysis, and drive change within the organization.
- Strong knowledge of concepts, practices, and procedures related to the biotechnology laboratory.
- Strong analytical, interpersonal, presentation and problem solving skills.
- Ability to analyze, break-down, and interpret a wide variety of information and form a strategic opinion while addressing the operational implications.
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.