Associate Director, CMC and Technical Operations

About Codera 

Codera is a Tang Capital company that provides in-house, end-to-end drug development 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 Associate Director, CMC and Technical Operations will develop and execute 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 

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 

Qualifications 

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% 

Codera is an equal opportunity employer. Codera is an E-verify employer.