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Online Resumes with "Consent Decree Remediation"



Director or better

Stable company willing to invest in people Need to be in the Phila, central and southern New Jersey areas

Tags for this Online Resume: Management, Project Management, Documentation, Business Management, Forecasting, Pharmaceutical, Audit, Compliance, Quality, Quality Assurance, Validation, Regulatory Affairs, CQV, Consent Decree Remediation, Compliance Remediation

Featured Profile

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