Senior Scientist - King of Prussia, PA

Position Summary

The Senior Scientist position in the Technology Development and Analytical Services (TDAS) group at the Center for Breakthrough Medicines offers a dynamic opportunity to contribute to both analytical development and GMP testing strategies for gene therapies. The role involves leading the design, development, and execution of biophysical and other methods to support early-stage development as well as GMP-compliant release and stability testing.

The successful candidate will work cross- functionally with process development, manufacturing, quality, and regulatory teams to ensure analytical methods are scientifically sound and aligned with regulatory expectations. In addition to conducting data analysis and providing technical guidance, the role requires ownership of analytical research projects that support the organization’s broader scientific and compliance goals across the product lifecycle.

• Lead and manage analytical method development, optimization, validation, and GMP release testing to support cell and gene therapy programs.
• Overseebothnon-GMPandGMPlaboratoryactivitiesrelatedtobiophysical method development, qualification, and lifecycle management across multiple programs.
• Support the team through analytical implementation and oversight of other assays, including molecular (PCR-based methods), ELISA and compendial assays.
• Drive the development and execution of robust analytical strategies, ensuring methods are scientifically sound and phase-appropriate for clinical and commercial stages.
• Collaborate cross-functionally with Process Development, Clinical and Commercial Manufacturing, and Quality teams to support method transfer, assay validation, investigations, and troubleshooting.
• Participate in regular client interactions and project meetings, applying scientific and regulatory knowledge to align deliverables with program timelines.
• Serve as a subject matter expert (SME) in analytical development and GMP testing, providing technical leadership and training where required.
• Support GMP testing operations by ensuring smooth implementation and execution of validated analytical methods for release and stability studies.
• Contribute to the design, qualification, and regulatory readiness of analytical methods to assess critical quality attributes such as identity, purity, potency, and safety.
• Provide strategic input to Development Operations and Clinical/Commercial Quality Control teams for analytical method implementation and ongoing performance monitoring.

• Master’s degree in biology, Chemistry, Engineering, or a related scientific discipline with a minimumof7- 9yearsofexperiencein
  
  R&D,Analytical Development,orGMPAnalytical Testing environments.
• Hands-onexpertisewithbiophysicaltechniquessuchas
  
  HPLC,Capillary Electrophoresis,Light Scattering, and other relevant instrumentation in both development and GMP settings.
• Priorexperienceinadvancedtherapyfield,eitherinindustryor academia,is preferred.
• Strongunderstandingofviralvectorbiologyparticularly Adeno Associated Virus ,Lentivirus,or Adenovirus is highly desirable.
• Familiarity with regulatory expectations and quality requirements in a GMP-regulated environment is required

• Strongverbalandwrittencommunicationskills,withtheabilitytoclearlyconveytechnical information to diverse audiences.
• Excellentinterpersonalandclient-facing skills,withafocusoncollaborationandcustomerservice.
• Highlyorganizedwithstrongattentiontodetailandaccuracyinbothdocumentationandexecution.
• Proventimemanagementskillsandtheabilitytoconsistentlymeetprojectdeadlinesinafast-paced environment.
• Stronganalyticalthinkingandproblem-solvingcapabilities,particularlyinmethoddevelopmentand troubleshooting.
• Demonstratedleadershipandteammanagementskills,withtheabilitytosuperviseandmentor junior staff.
• Effectiveattaskprioritizationanddelegationtoensureefficientworkflowandresource management.
• Proficient in Microsoft Office Suiteandcommonlyusedlaboratorydatasystemsandsoftware .
• Advancedtechnicalexpertiseinawiderangeofanalyticaltechniques,including
  
  HPLC,Capillary Electrophoresis, Mass Spectrometry, and related Analytical instrumentation.
• Skilled in designing, developing, and troubleshooting robust analytical methods to ensure high- quality, reliable results.

• Abilitytositforextendedperiodswhileworkingatacomputer.
• Must be able to occasionally lift and move items weighing up to 15 pounds.

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.