The Analytical Method Transfer (AMT) in our Morrisville, NC location group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs. The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long-term success of the methods entering into QC.
The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system.
The successful candidate requires the following knowledge, skills and abilities:
- Project management expertise for analytical activities (planning, timeline creation, team management, effective escalation, drive for success and on-time completion of activities)
- Technical expertise in several of the following fields, specifically in the analysis of proteins: plate based assays (SoftMax Pro), mass spectrometry, H/UPLC (Empower), electrophoresis, spectroscopy, microbiology (bioburden, endotoxin), and compendials including appearance, pH, osmolality. As a senior scientist, you must have demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
- Designing, managing and executing protocols for the Qualification, Validation, Verification or assay Tech Transfer of recombinant biopharmaceutical protein analytical methods. Experience with Master Control for document management is desired. Late stage method validation experience is also highly desired.
- Managing a team of scientists in a direct or matrix environment with an eye towards team development with high performing scientists.
- Regulated GMP experience, with knowledge of ICH guidelines for methods, positive working relationships with Quality groups and experience with opening, executing and closing protocol events, investigations and change controls within Trackwise. Regulatory audit experience is a plus.
- Strong oral and written communication skills. Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to engage with clients). The optimal candidate will have a keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients.
- Continuous improvement initiatives (initiating and completing).
- Excellent interpersonal skills, the ability to work individually or as part of a team; a person who highly values collaboration.
- Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
The position typically requires at a minimum:
- a PhD and 3+ year experience,
- MS and 6+ years’ experience or
- BS and 10+ years’ experience in the biopharmaceutical industry.
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.