Analytical Development Lead – Drug Product
Nitto Denko Technical is looking for an AD Lead to join our Analytical Development Team. We are currently developing Liposome-based pharmaceutical products, with complex platforms consisting of multiple components to be analyzed in parallel.
The AD Lead is responsible for establishing analytical methods, troubleshooting, and providing technical support for our drug development program. This position includes Analytical method development, with a particular focus on HPLC-UV/ELSD methods, method evaluation and verification. Experience in oligonucleotides and lipid analytics are desirable. Extensive chromatography experience is necessary, with preferred expertise in Waters/Agilent LC systems and Empower/OpenLab software platforms.
Specific job duties include:
• Perform analytical method development and optimization activities, with minimum or no guidance.
• Participate in method verification or transfers, with minimum or no guidance.
• Manage in-house and CMO stability study with minimum guidance.
• Review analytical data, prepare technical reports, and provide Analytical support for CMC conducted in-house or at CMO locations.
• Act as the point of contact with CROs/CMOs to support multiple stages of drug development.
• Train junior Research Scientists on HPLC/UPLC-based assays for RNA and lipid materials.
• Conduct laboratory, OOT, and OOS investigations.
• Contribute to the creation/revision of SOPs, COAs, protocols, and reports.
Other job criteria:
• Proficient with analytical method development using UPLCs/HPLCs with the following modes of detection: ELSD, MS, DAD/UV, MWD/UV, VWD/UV, and CAD.
• Must be knowledgeable in current industry techniques related to DLS, Osmolality, UV/vis, KF, etc.
• Familiar with cGMP and GLP regulation and ICH guidelines, is preferred
• Good communication and project management skills.
Hold a B.S. or M.S. in Chemistry or related discipline, with 5 to 8 years experience in the pharmaceutical industry, or an equivalent combination of education and experience. Experience in liposomal drug development is a plus. Experience with multiple phases of product development from the Analytical perspective is highly desirable.
Extensive LC chromatography experience is required, including but not limited to: NP, RP, IP-RP, IEX, and SEC. Hands-on experience with ELSD and CAD detectors, and Empower and OpenLab LC software is a particular asset.
Must have broad hands-on experience with computerized analytical instruments, databases, and spreadsheets; knowledge of cGMP; and good technical writing, problem-solving, and communication skills. The ability to work independently, as well as in a group setting, is necessary. Time management skills are critical to this position.