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Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA

General - 25 Years of Experience - Near 34744

Extensive experience in the management and supervision of personnel. Extensive knowledge in the administration and coordination of resource allocation. Extensive experience in crisis management, problem solving, and conflict resolution. Effective visionary, with the ability to communicate a clear mission and direction. Excellent management qualities with the ability to motivate and inspire team members toward a clear-shared...

Ideal Companies: Government agencies (state, local, or Federal), Medical Facilities, Public Safety,

Tags for this Online Resume: Budgeting, Operating Budget, Management, Assessments, Emergency Management, Policies and Procedures, Medical, Purchasing, Quality Assurance