Senior Scientist Analytical Development

1 month ago


Worcester, United States Life Science People Full time

Life Science People is supporting an innovative & lean start-up finalizing a strong Series A, and focused in the CNS space.


Analytical Development Senior Scientist

This position will support the daily operations of the Analytical Development Department by independently developing analytical methodologies to support the characterization, manufacture, release, and bioanalysis of large and small molecule drug candidates.


Responsibilities

  • Perform method feasibility, development, verification, transfer, qualification, validation and/or characterization testing of oligonucleotide therapeutics, proteins, and small molecules following company priorities, regulatory guidance, and management direction.
  • Identify, read, and comprehend applicable scientific and regulatory publications to guide a science-based approach to analytical testing and specification setting.
  • Perform routine laboratory support tasks such as mobile phase preparation, instrument maintenance, sample preparation, sample analysis, and data reduction.
  • Communicate effectively with internal and external stakeholders verbally or in written communications, including, but not limited to, schedule updates, presentation of technical data, interpretation of results, and/or collaborations on quality exceptions. Work closely with the team to resolve technical issues.
  • Read, understand, and review documentation such as laboratory methods, validation protocols, regulatory submissions, and specification justifications.
  • Prepare high-quality technical documentation, such as protocols, test methods, investigation summaries, and other technical reports working closely with relevant laboratory and/or Quality Assurance management.
  • Notify the Supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation/actions as needed.
  • Abide by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
  • Manage analytical work scopes at CROs and CDMOs, as appropriate.


Qualifications - Experience and Education

  • Degree in Chemistry, Analytical Sciences, or related field required.
  • Education Requirements waived in lieu of experience (PhD + 0 yrs, MS + 3 yrs, BS + 6 yrs).
  • Previous experience in large molecule analytical characterization is required.
  • Hands-on experience with liquid chromatography and mass spectrometry is required.
  • Previous experience in monoclonal antibodies, oligonucleotide therapeutics, and/or lipids preferred.


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