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Senior Research Associate, Analytical Chemistry RED

Position Summary:            

The Analytical Chemistry Senior Scientist, Research and Early Development, will actively design, execute, guide and critique the analytical activities to enable chemical and physical characterization of new molecular entities and formulations during discovery research, preclinical and early clinical development of novel anti-infective compounds.  Assure timely, appropriate method development, validation and implementation to meet project target profiles and ICH, FDA and ex-US standards through a combination of internal experimental and contracted GMP activities.  Small molecule projects will include a broad range of methods for characterization and quality control requiring strong competencies in chromatographic, spectroscopic and physical procedures, both compendia and novel, applied to raw materials, drug substance synthesis and drug product manufacturing. 

Essential Functions:

  • Establish and continuously improve methods, instrumentation and processes for chemical and physical characterization of NME molecules, working closely with medicinal and process chemistry teams.
  • Apply advanced knowledge to method development, including multi-dimensional chromatography (2D UPLC) and mass spectrometry (MS, MS/MS).
  • Guide, monitor and review method development, validation, and transfers for nominated new molecular entities and drug product projects.  Will work directly in internal laboratories; GMP activities will be with contract laboratories.
  • Define chemical reference standard strategies for NMEs and impurities for research and initial clinical development.
  • Critical review of contract laboratory data, protocols, reports, and investigations, including drug substance and drug product stability studies.
  • Clear, collaborative and effective communication with internal analytical research, chemical, biological, clinical, quality and regulatory functional groups, and with external laboratory and CMO staff and management.
  • Write, file and defend IND eCTD submissions; respond to agency comments and reviews.
  • Occasional domestic and international travel.
  • May manage research associate or scientist level staff.

Preferred Experience:

  • At least 8+ years research in preclinical/clinical phases in Pharmaceutical or Biotechnology industry.
  • Extensive experience with high resolution, high speed HPLC/UPLC systems (UV, CAD detectors), identification of drug and impurities by LC/MS and MS/MS, chiral separations, and CE in analytical and preparative modes. Hands-on experience with CDS (Empower, Chemstation, Chromeleon).
  • Strong knowledge of statistical analyses, DOE/QbD, major software (e.g., JMP, PRISM, Excel) Strong organic chemistry knowledge related to formation and identification of impurities and drugs.
  • Knowledge of current USP/EP/FDA/EMA compendial/guidances and compliance strategies.
  • Experience in parenteral formulations desirable.
  • Ability to effectively collaborate in a dynamic, fast paced, multidisciplinary team environment.
  • Ability to work independently or in team environments under deadlines.
  • Familiarity with contract work plans, scope and timeline management to engage CMO/CTLs.
  • Excellent verbal and written communication skills.

Preferred Education: 

  • PhD in chemistry/biochemistry or related field with 8+ years directly applicable experience.

Preferred Additional Skills:

  • Proficiency with MS Office, MS Project, quality system databases, electronic document management.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
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