Develop and execute CMC strategies and activities
Manage contract manufacturing organizations (CMOs) responsible for drug substance and drug product manufacturing, analytical testing, labeling and packaging
Ensure that drug substance and drug product control strategies and specifications are appropriate to meet relevant regulations
Design, conduct and report results for drug substance and drug product characterization
Develop, validate and continuously improve analytical methods
Collaborate with regulatory to assure accurate and complete CMC regulatory filings
Collaborate with quality assurance on vendor qualification and maintenance processes
Develop and implement appropriate metrics to measure manufacturing goals and objectives, including production cost and quality benchmarks

Bachelor’s Degree in Pharmaceutical Sciences, Biology, Biochemistry, Chemical/Biochemical Engineering, or related field required
Advanced degree preferred
Minimum 8 years of CMC and technical operations experience within the biotechnology or pharmaceutical industry
Experience with drug-device combination products; preferably dry powder inhalers
Deep understanding of drug development strategies, operations, cGMP regulations, formulations and differentiated drug delivery products
Outstanding written and verbal communication skills, including the ability to use clear language to explain complex matters
Possess a willingness and ability to work hands-on in a detail-driven, fast-paced, entrepreneurial environment
Ability to travel up to 20%

Associate Director, CMC and Technical Operations

Key skills