Will direct the Analytical Laboratory functions to establish appropriate control systems, which assure the chemical,
physical, and microbiological quality and integrity of the pharmaceutical products. Responsibilities include staffing, budgeting, and resource allocation. Expected results are
accurate test data provided by state-of-the-art analytical
methods. Will recommend and implement organizational
and technical improvements designed to enhance efficiency reliability and productivity. Direct the development of
control systems for new and revised drug products. Direct
and approve laboratory testing for the support and
documentation for all regulatory requirements (ANDA,
USP, consumer safety, etc) and assure that the analytical
control sections of ANDAs are approvable by the FDA. Review
and approve new and revised specifications for drug
substances and products. Solve analytical chemical
problems arising from the manufacturing process.
Communicate and reach agreement with FDA and
USP on analytical control systems. Coordinate analytical
activities with clinical studies and regulatory affairs. Will
manage 4 supervisors who supervise a total staff of 25.