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:
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• 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:
Apply tot his job
Apply To this Job