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Cedent Consulting - Worcester, MA

posted 2 months ago

Full-time - Senior
Worcester, MA
Professional, Scientific, and Technical Services

About the position

The Senior Scientist (Analytical Development) will play a crucial role in the Operations Science and Technology Biologics Division, managing all analytical aspects of biologics products throughout their lifecycle. This includes overseeing method transfer, performance monitoring, troubleshooting, and enhancement of commercial methods. The position also involves establishing product specifications, stability programs, and regulatory filings, requiring collaboration with various teams to meet business objectives and program milestones.

Responsibilities

  • Partner with Analytical Development groups to achieve commercial method readiness using traditional and advanced analytical techniques, including HPLC/UPLC methods, gel and capillary electrophoresis, ELISA, bioassays, spectrophotometric, and compendial methods.
  • Participate in cross-functional, multi-site, global meetings/projects and oversee commercial analytical method transfer between sites, product/process investigations, method performance monitoring, and troubleshooting.
  • Establish scientifically sound, analytical lifecycle strategies, including methods, stability, specification, and change management that meet Health Authority best practices and expectations.
  • Participate in the preparation and review of technical documents to ensure global compliance including validation protocols and reports, reference standard qualification reports, and analytical test procedures.
  • Author regulatory submissions, support regulatory inspections, and provide scientifically sound responses to agency deficiency letters.
  • Conduct periodic review of methods and work with program leads to design, execute remediation experiments, and implement changes to new or existing commercial methods when necessary.

Requirements

  • PhD in Chemistry, Biochemistry, Biological Sciences, or related scientific disciplines with 0-2 years of relevant experience, or MS/BS with 9-12+ years of relevant experience.
  • Proven experience in method development, qualification, validation, and method transfer in support of development and/or commercialization of biological products.
  • Experience with methods such as HPLC/UPLC, capillary electrophoresis, and spectrophotometric techniques.
  • Ability to lead and manage projects/teams of significant scope and complexity while meeting all deliverables and timelines.
  • Demonstrated critical thinking, troubleshooting, and problem-solving skills.
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