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Senior Scientist Analytical Development

2 months ago

Worcester, United States Cedent Consulting Inc Full time
The Senior Scientist (Analytical Development) will be an integral part of the Operations Science and Technology Biologics Division. The role involves managing all analytical aspects of biologics products on the market overseeing commercial methods throughout their lifecycle from method transfer performance monitoring troubleshooting to method enhancement. The individual will also play a key role in establishing commercial product specifications stability programs and regulatory filings. Collaboration with other analytical teams process development global QC and manufacturing science and technology groups is a crucial part of this role 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 but not limited to HPLC/UPLC methods gel and capillary electrophoresis ELISA bioassays spectrophotometric and compendial methods.

  • Participate in crossfunctional multisite 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.

  • Education: PhD in Chemistry Biochemistry Biological Sciences or related scientific disciplines with 02 years of relevant experience or MS/BS with 912 years of relevant experience.

  • Industry 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.

  • Project Management: Ability to lead and manage projects/teams of significant scope and complexity while meeting all deliverables and timelines.

  • ProblemSolving: Demonstrated critical thinking troubleshooting and problemsolving skills.