Alan Colborn Email & Phone Number

Morrisville, North Carolina, United States

Morrisville, North Carolina, United States

Senior Director, Analtyical Operations

Raleigh-Durham, North Carolina Area

Raleigh-Durham, North Carolina Area

Oversight of CMC activities at contract organizations developing new prescription medicine products.Support Dermavant new product development

Research Triangle Park, Nc

Scientific leader in the pharmaceutical industry. Specialties include: Development (Analytical, Formulation and Process Development), QA/QC, and Manufacturing, CMC submission writing and responses.

Research Triangle Park, Nc

Responsible for all global CMC activities that support programs from candidate selection through registration and commercialization including the development of active life cycle management programs. Accountable for the representation of CMC line functions on the Medicine Development Team.Establish strategic working relationships with several varied critical line functions (Regulatory Affairs, Commercial, Finance, Medical, Clinical Operations, Nonclinical, Legal

Research Triangle Park, Nc

Zebulon, Nc

Provided technical analysis and consultation locally and globally on product transfers, manufacturability of existing products, line extensions, and new productsLed investigations involving contaminants and impurities to determine impact on product quality. Decided on and implemented changes needed to eliminate issuesEvaluated and implemented technologies identified through Process Analytical Technology (PAT) and other technical initiativesLed a group of product complaint investigation specialistsCertified as Operational Excellence Green BeltLed the Solid Dose Risk Management and Product Trending processes

Zebulon, Nc

Directed activities of the Quality Control Labs at the Zebulon manufacturing site. Functions included stability study administration, testing labs for incoming materials, microbiology, product release and stability of solid dosage forms and metered dose inhalers, methods development, automation, and transfer labs, LIMS administration and development, and a project management group.

Research Triangle Park, Nc

Supervised group leaders of Development Microbiology, Analytical Services, and Stability and Packaging OperationsServed as CMC Project Team Leader LiaisonServed on Pharmaceutical Development Management TeamSupported CMC teams working on two HIV projects; included overseeing successful FDA Pre-Approval Inspection in Beinheim, France.

Research Triangle Park, Nc

Served on Analytical Sciences Management TeamLed department of 23 staff, (7 direct reports, 5 Ph.D., 16 B.S. /M.S.)-included staff located at RTP and Greenville, NCServed as CMC Project Team Leader for HIV tablets and oral solution projects in 1997Negotiated CMC issues for approval of HIV Tablet and Oral Solution project by French and German Rapporteurs as part of Centralized Review Process at the European Medicines Evaluation Agency; tentative approval 4/96, final approval 8/96.Assisted with administration of the full Analytical Sciences Department while the Director served on a re-engineering team.Coordinated space plans for all of Analytical Sciences for relocating staff from Greenville and consolidating space for long-term needs.Worked with group to harmonize international procedures for conducting drug stability studies.

Indianapolis, Indiana Area

Ph.D., Analytical Chemistry

B.S., Chemistry, Forensic Science

A.A, Science