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 QC Lead Investigator 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 deviation events related to QC testing.
Primary responsibilities will be to lead laboratory investigations, which will include initiating, authoring and drafting investigation reports and test plans, as appropriate. This role ensures the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with laboratory deviations. This person will lead root cause analysis sessions with site SME’s and determine the associated corrective action to prevent the deviation from recurring.
Essential Functions and Duties:
- Provide consistent direction and ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections.
- Conduct investigation in accordance to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.
- Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented reports.
- Apply expertise in laboratory disciplines to perform technically sound laboratory investigations in a timely manner to meet business and compliance needs.
- Collect, compile and analyze relevant data during the investigative process to ensure objective support for investigation outcomes.
- Demonstrate strong communication, project management and leadership skills, including the ability to interact and influence others at various levels of the organization.
- Collaborate with stakeholders and management, and communicate investigation status to management as appropriate.
- Determine scope, product impact, root cause and corrective actions for deviations from established procedures by interviewing, sampling, and applying the use of quality tools and techniques with realistic timelines for completion.
- Participate in Material Review Board meetings and evaluate recommendations made by the board regarding product disposition as it relates to the appropriate investigation.
- Present and defend investigations during regulatory inspections, as required.
- Mentor other Laboratory personnel and enable their individual growth with respect to deviation investigation completeness and GMP expectations.
- Remain current in regulatory expectations and industry practices regarding laboratory investigations and CAPA.
- Periodically review trends and update procedures accordingly.
Minimum Education Requirements
- BS/MS in relevant Science or Engineering discipline, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field
- 7+ years of experience in a cGMP pharmaceutical environment including leading laboratory investigations.
Specific Skills and Competencies
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
- Capable of interfacing with multiple levels of people within the organization, including Corporate management, third party customers, and plant personnel.
- Excellent verbal and written communication skills and attention to detail.
- Thorough understanding of the pharmaceutical/biotech testing, including ELISA, Western Blot, SDS-PAGE, Capillary Electrophoresis, Peptide Map, Size Exclusion Chromatography and other techniques.
- Excellent analysis, troubleshooting, and investigation skills required.
- Proven ability to conduct investigations, writing deviations and CAPA’s
- Proven ability to apply quality tools (Fishbone Diagrams, 5 Whys, etc.)
- Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.
- Superior technical writing and problem solving skills required.
- Ability to put complex thoughts and issues into writing in such a manner than an educated, but uniformed reader can understand and make decisions based on the written investigation report
- Ability to work cross-functionally with a diverse team.
- Experience in Trackwise system 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.