Associate Director, CMC and Technical Operations
Codera
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $160,000 - $230,000 per year
Job Level
About the role
- 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%
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC strategiesanalytical methodsdrug substance manufacturingdrug product manufacturingregulatory filingsvendor qualificationproduction cost metricsquality benchmarksdrug characterizationformulations
Soft Skills
written communicationverbal communicationdetail-orientedentrepreneurial mindsetcollaborationproblem-solvingadaptabilityteamworkleadershiptime management