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Senior Research Associate, Analytical Chemistry

Position Summary:            

The Analytical Chemistry Senior Research Associate will execute, support and coordinate the analytical activities to advance discovery/preclinical/clinical stage novel anti-infective compounds through development, regulatory submission and approval.   Perform method development, evaluation, and validation to meet project target profiles and ICH, FDA and EMA 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 primary competencies in chromatographic (U/HPLC/MS) and spectroscopic procedures, both compendial and novel, applied to raw materials, drug substance synthesis and drug product manufacturing. 

Essential Functions:

  • Characterize new chemical entity purity and phys/chemical properties for discovery research
  • Create and adapt HPLC/IC and phys/chem methods for NMEs, emphasizing impurity identification
  • Perform method development, validation, and transfers for nominated new chemical entities and drug product projects.  Flexibility to support drug discovery research programs in non-GMP internal facilities.
  • Will work directly in internal laboratories, and also interact with contract laboratories. 
  • Compilation, review and coordination of contract laboratory data, protocols, reports, and investigations, including drug substance and drug product stability studies.
  • Assist in writing and defending IND and NDA eCTD submissions; respond to agency comments and reviews; prepare for and support internal and contract laboratory PAI/GMP inspections.

Preferred Experience:

  • At least 8+ years of experience in preclinical/clinical phases in Pharmaceutical or Biotechnology industry.
  • HPLC/UV/MS/CLND/CAD and headspace/GC/FID/MS method development and validation experience.
  • Working knowledge of organic chemistry related to synthetic impurities and drug degradants
  • Experience in GMP regulated development laboratory.
  • Familiarity with current USP/EP/FDA/EMA compendial/guidances and compliance strategies.
  • Effective verbal and written communication skills.
  • Proficient with major chromatographic data systems and Microsoft Office.
  • Ability to effectively collaborate in a dynamic, fast paced, multidisciplinary team environment.
  • Ability to work independently from strategic management guidance or in team.
  • Knowledge of statistical analyses, DOE/QbD, major software (e.g., JMP, Minitab, Excel).
  • Experience in parenteral formulations.
  • Recent experience filing an IND or NDA, responding to FDA, and direct interactions with inspectors during PAI.

Preferred Education:

  • BA/BS degree in chemistry/biochemistry with 8+ years of experience or a MA/MS degree with 4+ years of experience.

Preferred Additional Skills:

  • Proficiency with MS Office, MS Project, quality system databases, electronic document management.
  • Proven ability to positively impact company culture and demonstrate flexibility in fast paced environment.
  • Current US work authorization required.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
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