Department: Manufacturing
Job Title: Senior Staff / Principal Scientist, Analytical Development
Summary
We are seeking a highly motivated individual with extensive pharmaceutical experience with small molecule analytical development. The ideal candidate will provide technical leadership and hands-on performance for the development of analytical methods applied to chemical and drug product development. The coordination of analytical development activities at contract manufacturers (chemical, product and analytical) is a key function of this position. Excellent verbal and written communication skills are required.
Duties and Responsibilities
· Lead, develop and transfer to primary contract manufacturers appropriate test procedures for chemical starting materials, chemical intermediates, drug substances and in-process controls
· Lead, develop and transfer to secondary contract manufacturers appropriate procedures for the assessment of the purity, potency and stability of drug product dosage forms.
· Support the development of robust chemical and drug product processes.
· Assist in the setting of specifications of drug substances, starting materials, chemical intermediates and drug products.
· Author technical reports and Chemical Manufacturing and Controls (CMC) documentation required for regulatory submissions.
· Actively participate in CMC Development Project Teams.
· Communicate with Chemical and Process Development, Formulation Development, Quality Control/Quality Assurance, and Regulatory Affairs to facilitate the development of candidate compounds and products.
Requirements
· Ph.D. in Analytical, Organic or Pharmaceutical Chemistry
· At least 10 years pharmaceutical industry experience in the analytical development of small molecules.
· Substantial knowledge of and experience in HPLC, GC, spectroscopic techniques, TGA and DSC.
· Experience with LC-MS and GC-MS with interpretive skills a plus.
· Working knowledge of cGMP and ICH Regulatory Guidelines
· Excellent verbal and written communication skills.
· Demonstrated leadership skills.