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Qodra | Intelligent solutions. Real-world impact
Associate Director, CMC and Technical Operations
Location
California
Posted
79 days ago
Salary
$160K - $230K / year
Seniority
Senior
Job Description
Associate Director, CMC and Technical Operations
Codera
• 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
Job 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%
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