Scientist

Job Title - Scientist
Job Location- Cambridge, MA
Job Duration - 7 months+
Shift- Standard
Pay -$60-66/hr. on w2

Must have- candidates with a focus on pep Product/protein analytical development and antibody characterization experience and this role would be involving early stage/CMC development.

Job Summary
Key Responsibilities:

• Develop, qualify, and troubleshoot chromatographic (GC, HPLC/UPLC) and LCMS based methods for the identification, characterization, and impurity profiling of oligonucleotideProducts, siRNAs, and their formulations, as well as raw material related analytical methods and other methods as needed.
• Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
• Provide analytical support for investigations leading by quality, manufacturing, supply chain.
• Perform testing of late development siRNA candidates and their formulations for their characterization.
• Author method development and qualification reports and SOPs for test methods. Evaluate suitability of new methods and oversee method qualification and validation in the external contract testing labs.
• Author and review analytical sections in regulatory submission documents.
• Apply strong technical knowledge of organic and analytical chemistry to support laboratory investigations (deviations/OOS/OOT), as needed.
• May serve as a primary contact person for cross-departmental needs or projects and be accountable for key deliverables.
• Contribute to the development and/or improvement of technical capabilities as well as initiatives to improve department efficiency.

• PhD in Chemistry, Biochemistry or related disciplines with 0-4 years industry experience, Masters degree with > 5 years related industry experience or Bachelors degree with > 8 years related industry experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise.
• Experience with HPLC/UPLC and LCMS-based analytical method development desired.
• Hands-on experience with oligonucleoProducts, proteins, or pepProducts is a plus.
• Familiarity with instrument troubleshooting and software including Empower, MassHunter, and UNIFI preferred.
• Knowledge of GxP requirements and application of statistical methods in the analytical laboratory is a plus.
• Strong interpersonal skills, communication, and collaboration.