Position HR047 – Research Scientist LC/MS
Location: Bridgewater, NJ
Nevakar is a specialty injectable bio-pharmaceutical development company, based in Bridgewater, New Jersey.
Products targeted for development by Nevakar are expected to address unmet clinical and commercial needs of currently available molecules, and thereby offer value proposition to patients, prescribers and payors. These products will be filed with FDA, primarily under 505(B)(2) regulatory pathway.
The Research Scientist will support Nevakar R&D by developing liquid chromatography- mass spectrometry (LC/MS) test methods, generating impurity profiles for raw materials and developmental products, elucidating degradant structures and degradation mechanisms. The successful candidate will perform job functions in accordance with the OSHA guidelines and ensure full compliance with FDA regulations and standard operating procedures. This position will work closely with Formulation Development team members.
- Development and application of LC/MS methods and other modern MS methodologies in support of injectable and ophthalmic drug product development;
- Determination of drug degradation mechanisms.
- Identification of impurities and degradants.
- Testing various samples in support of formulation development.
- Preparation of reports, protocols, and other technical documents.
A Ph.D. degree in Analytical Chemistry or related field with a focus on mass spectrometry, with 3+ years of experience, or an M.S. with 8+ years of experience, or a Bachelor’s degree with 10+ years of experience, or equivalent combination of education and experience is required.
3 years minimum experience supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred.
- Expertise in one or more of the following areas is a must: tandem MS, high-resolution, accurate-mass MS (HRAM), quantitative MS and LC/MS.
- In-depth understanding of organic reaction mechanisms as pertained to drug product stability studies and drug degradation pathways is highly desired.
- Hands-on experience with different MS platforms (Thermo, SCIEX, Waters, Agilent) and working knowledge of MS data acquisition and analysis software in application to structural elucidation are highly desired.
- Experience with Waters or Agilent chromatographic systems, UHPLC in particular, and knowledge of the Empower software is a plus.
- Desire to learn new techniques and methodologies with goal to implement those in the lab are highly preferred.
- Good communication skills as well as attention to detail are required.