Bryan Abney

Proven pharmaceutical professional with 30 years of progressive responsibilities in GMP active pharmaceutical ingredient/finished product laboratory and manufacturing environments
23 years of management experience – 15 in upper management at CMO and brand pharma

Skills – lean/six sigma, project management, analytical chemistry method development and validation, quality/regulatory requirements (FDA, DEA, OSHA, MHRA), PAI preparations, FDA remediation activities, process validation, risk assessment, quality by design, internal/external auditing, budgeting

Excellence-driven, team-centric management style with a history of remediation work improving company/laboratory capabilities and workflow

Track record of project management success achieving customer goals, driving lower costs, and improving compliance

Specialties: Analytical Chemistry, ICH and FDA guidelines, ANDA, NDA