Associate Director, CMC and Technical Operations

Job Description: • 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 Requirements: • 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% Benefits: