Kelley Meadows, Ph.D., Pmp Email & Phone Number

United States

• Project manager responsible for leading all aspects of initiating, planning, executing, monitoring/controlling and closing of projects to enable delivery of regulatory submissions to Health Authorities globally • Responsibilities include creating and negotiating submission timelines, leading dossier and submission planning teams, creating and maintaining submission content planners, monitoring and controlling dossier preparation and delivery against agreed upon timelines and closing projects. • Submission types include MAA, sNDA, CTA, IND, BLA, renewals and post-approval changes • Train and mentor junior staff • Liaise with submission publishing, RA CMC, area regulatory, global regulatory strategy, regulatory strategic planning, affiliates, global regulatory project teams, clinical and non-clinical SMEs and QA

•Led all analytical chemistry activities leading up to the successful submission of an NDA •Authored and supervised writing and completion of several analytical CMC sections of NDA filing•Authored analytical research methods•Ensured that timelines for analytical sections for NDA filing were met•Authored analytical sections of briefing book for pre-NDA FDA meeting •Justified commercial specifications and demonstrated effective communication and decision making skills during negotiations with commercial organization•Consistently demonstrated ability to meet aggressive timelines by using organizational skills, employing efficient work processes and negotiating timelines and workload•Worked collaboratively with process chemistry, process analytical, formulation, QA and RA colleagues on advancing compound to Phase 3 and driving towards completion of NDA filing•Critically evaluated, reviewed and approved analytical data for adherence to quality and regulatory standards•Designed, planned and performed laboratory experiments•Supported process validation and demo lot manufacturing activities at commercial site•Managed a group of analytical chemists•Responsible for all performance reviews, merit, goals and development plans for direct reports•Applied strong attention to detail in all tasks•Able to work independently with minimal guidance•Coordinated analytical testing and GMP paperwork associated with stability and release samples•Audited laboratory documentation for GMP compliance•Demonstrated ability to manage multiple projects

•Completed large scale protein purification process development, scale-up and validation in the laboratory•Managed a group of eight biologists. Responsible for all performance reviews, merit, goals and development plans for direct reports•Successfully transferred purification processes to GMP manufacturing site

•Performed enzymatic cleavage on integral-membrane polypeptides of light-harvesting complexes of photosynthetic bacteria to determine the peptide size and structure required for subunit and light-harvesting complex formation using an in vitro assay system •Chemically synthesized various peptides to determine functionally important amino acids in the light harvesting polypeptides. Purified enzymatically cleaved and synthesized peptides using reverse-phase HPLC

Ph.D., Chemistry

Activities and Societies: Iota Sigma Pi

Associates In Applied Science, Horticulture, With Highest Honors

Activities and Societies: Phi Theta Kappa Honor SocietyConcentration in natural areas management. Coursework included botany, woody.

Bs, Chemistry, Cum Laude

Diploma

Education record