Job Description:

Location: REMOTE

Salary: $180,000.00 USD Annually - $210,000.00 USD Annually

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

Contact: arawat@judge.com


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