Senior Scientist Analytical Development

4 weeks ago

Worcester, United States Cedent Consulting Inc Full time
The SeniorScientist (Analytical Development) will be an integral part of theOperations Science and Technology Biologics Division. The roleinvolves managing all analytical aspects of biologics products onthe market overseeing commercial methods throughout their lifecyclefrom method transfer performance monitoring troubleshooting tomethod enhancement. The individual will also play a key role inestablishing commercial product specifications stability programsand regulatory filings. Collaboration with other analytical teamsprocess development global QC and manufacturing science andtechnology groups is a crucial part of this role to meet businessobjectives and programmilestones.

Responsibilities:

  • Partnerwith Analytical Development groups to achieve commercial methodreadiness using traditional and advanced analytical techniquesincluding but not limited to HPLC/UPLC methods gel and capillaryelectrophoresis ELISA bioassays spectrophotometric and compendialmethods.

  • Participatein crossfunctional multisite global meetings/projects and overseecommercial analytical method transfer between sites product/processinvestigations method performance monitoring andtroubleshooting.

  • Establishscientifically sound analytical lifecycle strategies includingmethods stability specification and change management that meetHealth Authority best practices andexpectations.

  • Participatein the preparation and review of technical documents to ensureglobal compliance including validation protocols and reportsreference standard qualification reports and analytical testprocedures.

  • Authorregulatory submissions support regulatory inspections and providescientifically sound responses to agency deficiencyletters.

  • Conductperiodic review of methods and work with program leads to designexecute remediation experiments and implement changes to new orexisting commercial methods whennecessary.

  • Education:PhD in Chemistry Biochemistry Biological Sciences or relatedscientific disciplines with 02 years of relevant experience orMS/BS with 912 years of relevantexperience.

  • IndustryExperience:Proven experience in method development qualification validationand method transfer in support of development and/orcommercialization of biological products. Experience with methodssuch as HPLC/UPLC capillary electrophoresis and spectrophotometrictechniques.

  • ProjectManagement:Ability to lead and manage projects/teams of significant scope andcomplexity while meeting all deliverables andtimelines.

  • ProblemSolving:Demonstrated critical thinking troubleshooting and problemsolvingskills.



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