COONEY PHARMA CONSULTING - Key Persons

Job Titles:

• Managing Member
• Principal Consultant

Rita holds a Ph.D. in Analytical Chemistry from the Georgia Institute of Technology, Atlanta, GA. She also has a B.A. in Biology and a B.S. in Chemistry. She is a highly competent and successful Executive Leader in Analytical Research and Development (ARD) and Quality Control (QC), with 30+ years in the pharmaceutical and specialty/fine chemical industries. Her career path includes a steady increase of responsibility and advancement from bench scientist to executive management positions, in the areas of fine chemicals (including API) and brand and generic pharmaceutical products. She has a solid breadth of development experience across many areas of pharmaceutics, including drug substances (small molecule API), excipients, and solid and liquid (including sterile) drug products. Rita most recently served as Director of Analytical Sciences (R&D and QC) at an API CDMO company, and prior to that as Sr. Director of Analytical R&D at a large generic drug developer and manufacturer. Earlier, she held various management positions in Analytical R&D within the Pharmaceutical R&D Divisions of global companies. Rita has a full understanding of both drug substance and drug product development processes from pre-clinical to NDA (and ANDA)commercial launch, along with the cGMP manufacturing processes and requirements associated. While most of her career has been in Analytical R&D, she was situated at cGMP manufacturing facilities and worked closely with Quality, Engineering, Manufacturing, Project Management, Procurement, Business Development, Legal and Regulatory Affairs organizations to successfully execute project deliverables, regulatory filings, and launch new commercial products. She also was instrumental in rectifying problematic products and processes, and help reduce the cost of lost product. Rita has Implemented new cGMP analytical laboratories and remediated inefficient existing operations. She has directed organizations of over 50 technical and management staff while significantly improving technical competency and organizational discipline. She possesses a thorough understanding of cGMP, compendial, ICH, and CMC requirements for filing IND, NDA,, ANDA, and DMF regulatory applications. She was a vital member of several corporate executive management teams, as well as committees for quality compliance, new business development, internal R&D product pipeline review, lean manufacturing, and corporate acquisition due diligence. Core competencies include: