Job ID: #8590

Scientist, Analytical Development

Waltham, MA
Science Science
Research & Development

 

Responsibilities of the Scientist, Analytical Development:

  • Lead method validation/qualification activities, authoring and/or reviewing protocols, and coordinating testing with Contract Research Organizations (CROs).
  • Lead the stability program and provide timely stability updates for regulatory documents.
  • Generate standard operating procedures for the characterization of biologics.
  • This role will also train lab members and manage the transfer of methods to
  • Contract Manufacturing Organizations (CMOs).
  • Identify and stay current with new analytical technologies and methods for the characterization of biologics.
  • Perform characterization and degradation studies on lead candidates, critically assess findings and share results with cross-functional teams.
  • Manage timelines and milestones for analytical assessment of lead candidates and ensure a smooth transfer to CMOs and Contract Test Organizations (CTOs).
  • Provide subject matter expertise support in determining the proper fit for Contract Test
  • Organizations (CTOs) for assay transfer, develop protocols or assay qualification and validation, and review and approve data.
  • Prepare presentations for external partners and internal meetings and represent analytical and CMC issues.
  • Provide analytical support for investigations at CTOs and CMOs, generate hypothesis, critically review results to support deviations, Out Of Specification (OOS) results,
  • Corrective And Preventative Actions (CAPAs).
  • Review analytical development reports, assay and process validation reports and other technical documents for technical correctness and regulatory compliance.
  • Travel to CTO sites may be required as needed to assist with site audits (up to 5% travel).
  • Other duties and responsibilities as required by departmental and business needs.

Requirements of the Scientist, Analytical Development:

  • A PhD degree in analytical chemistry, biochemistry or a related analytical scientific discipline with 1-5 years of experience, a BS with 7 years or an MS with 5 years’ experience.
  • Hands-on experience with some of the following analytical methods: ELISAs, cell-based potency assays, HPLC, UPLC, CE-SDS, SDS-Page, protein purification, CEX, icIEF, and Mass
  • Spectrometry.
  • Experience with statistical and analytical software, such as SPSS, JMP, Excel, and SAS

 

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

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    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.