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Oligonucleotide Method Development & Validation

Eurofins Scientific

Lancaster, PAFull-timeNo compensation foundPosted 1mo agoVerified open 5 days ago

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At a glance

Compensation
No compensation found
Location
Lancaster, PA
Schedule
Full-time
Work Authorization
US work authorization required

Requirements

Credentials this posting asks for.

Doctorate

Job overview

Eurofins Scientific is hiring an Oligonucleotide Method Development & Validation. The Oligonucleotide Scientist develops, optimizes, validates, and executes analytical methods for oligonucleotide API, drug substance, and drug product testing. This role supports pharmaceutical clients through various drug pipeline stages, focusing on HPLC/UHPLC and mass spectrometry for identity, purity, quantitation, and stability assessments. The scientist authors methods, protocols, and reports, ensures data integrity, and provides technical leadership and mentoring.

Key focus areas include Perform a large variety of analytical tasks for method validation, Read, understand, and interpret diverse analytical procedures, and Conduct analytical investigations.

Successful candidates bring Bs In Analytical Chemistry Or Equivalent, Ms In Analytical Chemistry Or Equivalent, and Phd In Analytical Chemistry Or Equivalent. Important skills include HPLC, UHPLC, Mass Spectrometry, LC-MS, Method Development, and Method Validation. Preferred (not required): Excellent Communication, Attention To Detail, Work Independently, and Collaboration.

Skills & qualifications

RequiredNice to have

Skills

HPLCUHPLCMass SpectrometryLC-MSMethod DevelopmentMethod ValidationAnalytical Method ExecutionAPI TestingDrug Substance TestingDrug Product TestingIdentity TestingPurity/Impurity ProfilingQuantitationStability-Indicating AssessmentsAuthoring MethodsAuthoring ProtocolsAuthoring ReportsData IntegrityCompliance Within GxP EnvironmentsTechnical LeadershipRoutine TestingInvestigationsMentoring Junior StaffGCUV/VisDissolutionInterpreting Analytical ProceduresTroubleshoot InstrumentationClient Project ManagementGMPOligonucleotide Analytical TestingChromatographyIEXSECICH GuidelinesGxP Regulatory StandardsExcellent CommunicationAttention to DetailWork IndependentlyCollaborationSelf-MotivationAdaptabilityPositive AttitudeLearn New TechniquesPerform Multiple Tasks SimultaneouslyKeep Accurate RecordsFollow InstructionsComply With Company Policies

Qualifications

Authorization to Work in the U.S. IndefinitelyBS or MS Degree in Analytical Chemistry or Related Scientific DisciplineBS and 4+ Years Relevant Industry ExperienceMS and 2+ Years Relevant Industry ExperiencePhD and 1+ Year Relevant Industry ExperienceExperience Performing Analytical Testing With Oligonucleotides in a GMP-Regulated EnvironmentBackground Primarily in Analytical Testing or Analytical Method Development

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
401(k) Match
Paid Time Off

Full job description

**Applicants MUST have authorization to work in the U.S. indefinitely without restriction or sponsorship. **

Job Summary: 

The Oligonucleotide Scientist is responsible for developing, optimizing, validating, and executing analytical methods to support oligonucleotide API, drug substance, and drug product testing.  The role supports pharmaceutical clients throughout various stages of the drug pipeline but does not support or include synthesis/manufacturing of oligonucleotides. The role focuses primarily on HPLC/UHPLC and mass spectrometry (e.g., LC‑MS, LC‑MS/MS) for identity, purity/impurity profiling, quantitation, and stability-indicating assessments. The scientist will author methods, protocols and reports, ensure data integrity and compliance within GxP environments, and provide technical leadership for routine testing and investigations and mentoring of junior staff. Additional tasks/skills will include:

  • Performing a large variety of analytical tasks for the validation of analytical methods used in the testing of drug products and raw materials by means of various procedures including HPLC, GC, UV/Vis, and dissolution.

  • Reading, understanding, and interpreting diverse analytical procedures.

  • Conducting analytical investigations.

  • Troubleshoot instrumentation and communicate with vendors when required.

  • Train and mentor junior staff in laboratory procedures.

  • Manage and discuss projects with clients.

  • Applies GMP in all areas of responsibility, as appropriate. The Ideal Candidate would possess:

  • Excellent communication (oral and written) and attention to detail.

  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Minimum Qualifications:

  • At least a BS or MS degree in Analytical Chemistry or related scientific discipline

  • BS and 4+ years, MS and 2+ years, or PhD and 1+ year of relevant industry experience

  • Experience performing analytical testing with oligonucleotides in a GMP-regulated environment

  • Technical Expertise: Strong theoretical and practical knowledge of chromatography (HPLC, UHPLC, IEX, SEC) and mass spectrometry, including method development, validation, and routine testing

  • Regulatory Knowledge: Familiarity with ICH guidelines and GxP regulatory standards

  • Background should be primarily in analytical testing or analytical method development; candidates with primarily synthesis or process chemistry experience without analytical/QC responsibilities will not be considered

  • Authorization to work in the U.S. indefinitely without restriction or sponsorship Working schedule will be  Full-Time, First Shift, Mon-Fri, 8am-4pm.  Candidates  currently living within a commutable distance of Lancaster, PA  are encouraged to apply. 25% travel may be required. This position is  NOT  remote. 

What we Offer:

  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

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