The Analytical Method Transfer (AMT) group is seeking a Senior Scientist, program technical lead to manage the team-based execution of client-based projects. The AMT group is a protocol-driven group which 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. The position will primarily focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification), 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 throughout. The candidate will be expected to follow cGMP documentation practices and initiate deviation, lab investigation, method revisions and other related activities within the quality system.
The successful candidate requires the following knowledge, skills and abilities:
- Demonstrated ability to design, manage and execute analytical studies to support the transition to cGMP testing of recombinant biopharmaceutical proteins
- Hands on experience in several of the following technical fields, specifically in the analysis of proteins: H/UPLC (Empower), electrophoresis, spectroscopy, microbiology (bioburden, endotoxin), compendial appearance and/or plate based assays (PLA, SoftMax Pro).
- Experience managing a team of scientists in a direct or matrix environment.
- Experience working in or interfacing with a regulated GMP environment.
- Strong oral and written communication skills. Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to engage with clients).
- Good interpersonal skills, the ability to work individually or as part of a team, and demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
- In addition, the successful candidate must be comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
- The position typically requires a PhD and 1+ 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.