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Scientist, Analytical Development

Employer
Commonwealth Sciences, Inc.
Location
Boston, MA
Closing date
Jun 24, 2022

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Sector
Science, Pharmaceutical, Laboratory
Organization Type
Corporate
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Position located in Waltham, MA

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
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