SUMMARY:

We are seeking a highly motivated, well-organized, and detail-oriented scientist who can work effectively in a fast-paced and multi-disciplinary environment. The position is in the ARD laboratory of Kashiv’s Piscataway facility in NJ. The Scientist Mass Spec and Characterization will be responsible for development of LC-MS methods for protein characterization along with other analytical tools involving HPLCs and UV Spectrophotometry. Additional responsibilities include support of method transfer to QC laboratories when required and liaising with CROs and other R&D labs of Kashiv BioSciences. Basic LC-MS and HPLC operation experience is required. Experience with sequence elucidation of protein using LC-MS/MS is desired. The candidate must have experience authoring SOPs and technical reports and should be able to collaborate laboratories for method and data transfer.

Essential Duties and Responsibilities:

· 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.

· 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. Perform MS analyses of biologics. These studies include but are not limited to, protein molecular weight analysis, peptide mapping, protein sequencing, post-translational modifications qualitative and quantitative analyses, and glycan structural analysis using primarily but not solely high-resolution mass spectrometry.

· Prepare chemical solutions and perform detailed and complex analytical procedures (e.g., digestions, purifications, buffer exchanges, etc.) following SOP and established test protocols.

· Write and review reports, protocols, and any documentation in relation to the performance of the work.

· Work closely with Quality Assurance to meet all necessary regulatory requirements.

PREREQUISITES:

Education:

· Minimum B.S. degree in Analytical Chemistry, Biophysical/Biochemical Sciences, Pharmaceutical Sciences with 5 years industry experience

· Or Master’s Degree in Biochemistry, Biotechnology, Biology with 2+ years’ experience in protein mass spectrometry

· Or Ph.D. in Biochemistry, Biotechnology, Biology with 1+ years of experience in protein mass spectrometry

Experience:

· A strong theoretical understanding and experience in protein chemistry and biochemistry.

· Experience with operation of LC-MS, HPLC and UV techniques is required.

· Experience with HPLC methods like peptide mapping, SEC, CEX is required.

· Protein sequencing experience is derived.

· Familiar with ICH guidelines and USP/EP pharmacopeia requirements

· 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.