AD Microbiology, Fujifilm Diosynth Biotechnologies
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 an Associate Director of Microbiology 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 to microbiological-related manufacturing and laboratory challenges.
Primary responsibilities will be to support, plan, manage, and execute the daily, short-term and long-term activities, and goals associated with microbiology lab, environmental monitoring, and product testing programs within the Quality Operations team to support the manufacturing of biologic products.
Essential Functions and Duties:
Responsible for the strategy and direction of the Quality Control Microbiology group, which includes:
- Builds partnerships and communicates with colleagues and peers across departments to ensure successful delivery of key milestones
- Regularly interacts with management on matters concerning responsible functional areas, divisions and/or customers
- Supports client audits and regulatory agency inspections as the microbiology (bioburden, endotoxin and environmental monitoring) subject matter expert.
- Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future compliance risks while maintaining an effective operation to support business needs.
- Conducts investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- Coaches and leads the microbiology team in best practices, risk management of requirements, and corporate goals/culture
- Assures laboratory is organized in a manner to effectively meet test schedules, setting priorities, assuring adequate coverage is provided for off-shift and weekend activities
- Facilitates appropriate knowledge management and cross training occurs within the group, assuring continuity to testing and facility support
- Reviews and critically assesses SOPs, methods, batch records, and various qualification protocols and reports.
- Establishes user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state
- Develops laboratory expense and personnel tools for determining near and long term resource and materials requirements for budgeting and project management purposes
Desired Qualifications and Skills:
- Bachelor’s Degree in Microbiology or Biological Sciences. Advanced or doctorate degree in a scientific discipline preferred.
- Minimum 10 years of experience in the pharmaceutical/biotech industry with a minimum of 8 years’ experience leading teams in a FDA-regulated environment.
- Demonstrated leadership and management skills, including establishing direction and goals.
- Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), bioburden, endotoxin, Microbial Identification, Process Validation and other applicable methods to the testing of biopharmaceuticals
- Ability to develop a clear functional strategy, prioritize activities, coach & guide team members effectively and to deal with multiple parallel competing activities is a must.
- Strong orientation for quality, compliance, business ethics and customer service
- Strong interpersonal skills; the ability to interact effectively with all levels within the organization, external third parties, and regulatory authorities
- Extensive experience in conducting laboratory and environmental excursion investigations.
- Scientific writing skills and ability to prepare technical studies and SOPs highly desired
- Comprehensive knowledge of quality principles and GMP, ICH and ISO regulations.
- Self-driven, independently motivated, data driven, and excellent problem-solving ability.
- Knowledge of Trackwise, LABWARE LIMs and SAP preferred
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.