Description: Our client is currently seeking a Director, Process Chemistry - Drug Substance (CMC)
The Director, Process Chemistry, Drug Substance (CMC) will serve as a technical subject matter expert responsible for drug substance process development from clinical development through commercialization. The successful candidate needs to demonstrate a proven track record of working in a remote virtual environment with contract development & manufacturing organizations (CDMOs) to deliver manufacturing processes that can be scaled to batch sizes sufficient to support fast-paced clinical development programs.
The successful candidate will work closely with cross-functional teams, including CMC, analytical chemistry, quality assurance, and regulatory affairs personnel.
Qualifications
Bachelor's or Master's degree in chemistry, chemical engineering, pharmaceutical sciences, or a related field with 8-10 years experience. A Ph.D. degree is preferred but is not required.
Strong fundamental knowledge of organic chemistry and steroid chemistry, including synthesis, purification, and characterization techniques.
Familiarity with regulatory requirements and quality standards governing drug substance development and manufacturing (e.g., GMP, FDA, ICH guidelines).
Advanced proficiency in analytical techniques commonly used for drug substance characterization (e.g., HPLC, GC, NMR, mass spectrometry).
Experience with process validation and statistical analysis.
Experience with complex dosage forms/Combination products
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Manufacturing, and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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