Employment - Director, Analytical Chemistry

Purpose of Job:

Provide strategic and tactical direction with regard to analytical chemistry and drug formulation to assure that the company is in compliance with US and international regulatory requirements and will be successful in securing regulatory approvals on a timely basis.

Major Duties and Primary Responsibilities:

  • Assure awareness of and compliance with all US (e.g., FDA Guidelines, cGMP) and international regulatory approval (e.g. ICH Guidelines, EMEA Guidelines) and compliance requirements (cGMP and Quality System) as they relate to analytical testing and drug formulation.
  • Assure that the analytical chemistry groups are adequately staffed to support the method development, method validation, stability testing, drug formulation, and release testing activities.
  • Assure that the analytical chemistry groups have adequate facilities for analytical testing and drug formulation.
  • Assure that the analytical chemistry groups have adequate equipment and that the equipment is maintained in accordance with normal operational and Quality System requirements.
  • Secure and maintain the confidence of management regarding awareness of and compliance with all US and international regulatory approval and compliance requirements, accuracy and robustness of analytical methods, competence of analytical staff, and accuracy of test results and test reports generated by analytical chemistry.
  • Assure that the company establishes and maintains good relationships with reputable outside laboratories needed to perform activities that cannot practically be done by the company.
  • Draft applicable portions of regulatory submissions (e.g., CMC section for FDA, CTD for CE Design Dossier, responses to questions).
  • Participate in third-party audits (FDA, Notified Body), as required, involving assessment of compliance with cGMP and Quality System requirements.
  • Provide strategic and tactical leadership and direction in solving analytical chemistry and drug formulation problems.

Job Requirements:

Doctoral Degree in Chemistry and a minimum of 10 years of increasingly responsible industry experience (including a minimum of 7 years' experience in pharmaceutical development or drug delivery), or equivalent combination of education and experience. Extensive knowledge of CMC requirements; has written CMC sections for NDA that has received approval. Knowledge of and competence in application of CFRs (210/211 and 820), and ICH Guidelines; analytical organization for which candidate was responsible has passed cGMP inspections. Advanced computer skills specifically in Microsoft Word, Excel and Adobe Acrobat. Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences. Strong team leadership experience and motivational skills. Success with gaining consensus from multidisciplinary teams.

Interested candidates should submit their resumes via email.