Scientist, Mass Spec & Characterization, Biosimilars ARD

GlycoData; Piscataway Township (NJ); In loco; USD 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

GlycoData is looking for a Scientist specializing in Mass Spectrometry and Characterization for its Biosimilars division located in Piscataway, NJ. The successful candidate will develop and optimize chromatography methods, support the testing of samples, and ensure compliance with quality standards.

The position requires a minimum of a B.S. degree in a related field, with specific experience in protein mass spectrometry. Applicants should possess strong analytical skills and the ability to write detailed technical documents.

Competenze

• Minimum 5 years industry experience with a B.S. degree.
• Experienced in method development in a GLP/GMP environment.
• Strong communication and technical writing skills.

Mansioni

• Develop LC-MS methods for sequence elucidation.
• Support sample testing during biosimilar development.
• Independently write technical reports and summaries.

Conoscenze

Protein chemistry

Biochemistry

LC-MS operation

HPLC techniques

Formazione

B.S. in Analytical Chemistry or related field

Master's Degree in Biochemistry or Biotechnology

Ph.D. in Biochemistry or Biotechnology

Strumenti

LC-MS

HPLC

UV techniques

Descrizione del lavoro

Scientist, Mass Spec & Characterization, Biosimilars ARD – Kashiv Biosciences

Location: Piscataway, NJ

Posted on: June 04, 2026

Description:

• 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.

Requirements

• 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+ year 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.