Kashiv Pharma, LLC.
Piscataway, NJ, United States
Sciences, Scientist, Chemistry
We are seeking a Scientist III-AR&D to be based out of our HQ in Piscataway, NJ. The Scientist III Biophysical Characterization will be responsible for phase specific analytical method development and sample testing required for structural and Biophysical characterization of biologics through various phases of biosimilar development. Additional responsibilities include support of method transfer to QC laboratories and liaising with CRO laboratories. Techniques employed include but are not limited to Chromatography, LC-MS and spectroscopic techniques. Experience with sequence elucidation of protein using LC-MS/MS is desired. The candidate must have experience authoring SOPs and technical reports. The successful candidate will be a highly motivated, well-organized, and detail-oriented scientist who can work effectively in a fast-paced and multi-disciplinary environment.
Development of LC-MS methods and workflow for sequence elucidation and identification of sites of chemical modification in the sequence.
Development of chromatography methods for quantification of related impurities.
Development and routine testing on FTIR, DSC, CD, Fluorescence etc (Spectroscopic methods).
Support sample testing as necessary for various stages of biosimilar development
Provide technical inputs to team members with respect to HPLC/UPLC troubleshooting, method development, method validation, etc.
Ensure adherence to highest quality and efficiency standards in laboratory operations (cGLP, cGMP)
Develop, optimize and validate new chromatography methods using literature references and scientific principles.
Implement and when necessary, optimize compendial test methods.
Independently write experiment summaries, development reports, technical reports, operation and test method procedure documents, and review documents comprising, but not limited to standard operating procedures, standard test methods, validation protocols and reports, etc.
Foster morale and teamwork
A strong theoretical understanding and experience in protein chemistry and biochemistry.
Experience with a wide variety of peptide mapping, HPLC and UPLC techniques including RPLC, SEC, HIC, IEX, at a minimum.
Familiar with ICH guidelines and USP/EP pharmacopeia requirements
Experience in the isolation and enrichment of product- and process-related impurities
Excellent communication and technical writing skills
Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment
Strong experience in analytical method development and validation
Demonstrated skills as a team-player.
SPECIALIZED KNOWLEDGE AND SKILLS:
Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required
Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.
Experience with Mass Spectrophotometer is required.
Experience with Empower and/or ChemStation HPLC software programs is required.
Experience with any or all of the following is considered advantageous: spectroscopy (UV-Vis, CD, and fluorescence), mass spectrometry, DOE software, strong knowledge of statistics.
Education\u2022 Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 12 years industry experience \u2022 Or Master\u2019s Degree in Biochemistry, Biotechnology, Biology with 5-7 years industry experience \u2022 Or Ph.D. in Biochemistry, Biotechnology, Biology with 2-3 years\u2019 experience.
Kashiv Pharma, LLC.
Website : http://www.kashivpharma.com