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Senior Scientist, Analytical Chemistry

Position Summary:            

The Analytical Chemistry Senior Scientist will actively design, guide and critique the analytical activities to advance preclinical/clinical stage novel anti-infective compounds through development, regulatory submission and approval of the drug substance and drug product.  Assure timely, appropriate method development, validation and implementation 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 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:

  • Guide, monitor and review method development, validation, and transfers for nominated new chemical entities and drug product projects.  May work directly in internal laboratories, majority of activities will be with contract laboratories.
  • 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 and NDA eCTD submissions; respond to agency comments and reviews; prepare for and support internal and contract laboratory PAI/GMP inspections.
  • Lead and coordinate chemical reference standard management program for internal research/GLP and for contract GMP activities.
  • Apply advanced knowledge of techniques to method development and life cycle management.
  • 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, chiral separations, electrophoresis in analytical and preparative modes, and with MS and advanced, selective detectors.
  • Strong organic chemistry knowledge related to formation and identification of impurities and drug.
  • Knowledge of current USP/EP/FDA/EMA compendial/guidances and compliance strategies.
  • Recent experience filing an NDA, responding to FDA, and direct interactions with inspectors during PAI.
  • Strong knowledge of statistical analyses, DOE/QbD, major software (e.g., JMP, Minitab, Excel).
  • Experience in parenteral formulations and characterization of container closure systems. (extractables, leachables, physical/functional).
  • Experience with cleaning test method validation in multi-product cGMP environments.
  • 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; MS/MA with 12+ years 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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