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 Director / Senior Director of QC is responsible for directing Fujiflm Diosynth Biotechnologies U.S.A., Inc. (FDBU) Quality Control (QC) Laboratory operations at the Morrisville North Carolina site. The QC laboratories, equipment, operations, methods, and procedures are expected to be maintained in compliance with applicable cGMP regulations. The FDBU QC Laboratory provides analytical and microbiological testing of: raw materials; both clinical and commercial Active Pharmaceutical Ingredients (API) and Drug Products (DP) for in-process, release and stability programs; cleaning and Environmental Monitoring. This position is expected to provide strong leadership within their department, as a key cross-functional partner within the site, and a partner with our customers regarding QC operations. They are responsible for assuring compliance in the Quality Control laboratory operation, managing and developing people, managing to budget, achieving revenue and profit goals.
Essential Duties and Responsibilities
- Assure all QC areas of responsibility operate in accordance with all applicable safety and cGMP regulatory requirements and best practices.
- Direct QC operations support to meet or exceed site operational objectives and budgets.
- Establish and maintain highly effective cross-functional partnerships within the Morrisville NC site, with other sites within the FDB network, and with our business customers.
- Represent and work with staff to effectively represent QC for client visits, audits, and regulatory agency inspections.
- Ensure budgets, operational milestones, and performance requirements are met.
- Establish and maintain programs for QC staff development, training, certifications, goals, and objectives.
- Works with other directors and senior staff in establishing and implementing company-wide QC systems, programs, and goals.
This position reports to the site head of the Quality organization. It may have multiple manager and/or supervisor positions responsible for the various QC disciplines directly reporting to it. Additionally, the position may have multiple individual contributor positions, generally in the QC Scientist functions reporting to it. Overall, the position may have 50 or more direct and indirect staff in the organization.
- Manages a staff of 5+ managers/supervisors and 50+ indirect staff.
- Manages a budget of approximately $5-10 mm
- B.S. in scientific discipline with > 12 years experience in a Quality Control environment
- M.S./M.A. in Chemistry, Biochemistry or Microbiology and 10-12 years experience
- PhD. and 8-10 years of experience.
- Prior experience with biotech products is expected. Significant management experience is required.
Also requires a demonstrated track record in the following key areas:
- Strong orientation for quality, compliance, business ethics and customer service High level of integrity, personal discipline and personal responsibility.
- Strong collaboration and team building skills
- A strategic thinker, able to motivate, lead and develop subordinates and the site leadership
- Prior Lean Six Sigma background and certification is a plus.
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.