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Specific Knowledge, Skills, Abilities, etc:

Comprehensive knowledge and experience of analytical methodologies used for the development and commercialization of pharmaceutical products. Demonstrate a broad expertise and experience in analytics routinely used for in-process, release and stability testing of drug substance and drug product, product characterization and strategies to establish process and product knowledge.

Extensive knowledge of the drug development process, analytical strategy and specification setting for drug substance and drug product

Familiar with FAD, ICH guidance and major Pharmacopoeias. Working knowledge of CMC regulations and cGMP requirements, as well as experience in supporting regulatory filings and post approval changes.

Strong communication and leadership skills in a highly interactive and fast paced environment.

Experience in working with cross-functional strategic teams and collaboration with internal and external partners.

Education/Experience/ Licenses/Certifications

A PhD, MS, or BS in Analytical Chemistry, Chemistry, or related disciplines with at least 1, 3, or 4 years of pharmaceutical industrial experience in relevant fields, respectively.

Physical Demands and Work Environment

This is primarily a analytical subject expertise and analytical project management role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting requiring:

Inside Work

Working Alone

Working with/around others