What are the responsibilities and job description for the Executive Director, CMC and Technical Operations position at Codera?
Job Description
Job Description
Salary : 275,000-315,000
About Codera
Codera is a Tang Capital company that provides in-house, end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Executive Director, CMC and Technical Operations will oversee the development and execution of chemistry, manufacturing and controls (CMC) activities to advance domestic and international drug development programs from early development through commercialization. Drug development programs may include drugs and biologics. Product candidates may include solid oral dosages, injectables and drug-device combination products (e.g., dry powder inhalers).
Essential Duties and Responsibilities
Oversee development and execution of CMC 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
Qualifications
Bachelors or higher Degree in Pharmaceutical Sciences, Biology, Biochemistry, Chemical / Biochemical Engineering, or related field required
Advanced degree preferred
Minimum 5 years of CMC and technical operations experience within the biotechnology or pharmaceutical industry
Experience with drug-device combination products
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 25%
Codera, LLC is an equal opportunity employer. Codera, LLC is an E-Verify employer.
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