Summary: Seeking an experienced Lead Chemist to support R&D initiatives in pharmaceutical or biotechnology CMC/cGMP environments.

Requirements:

Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, or related field; Master's or PhD preferred

Minimum 8 years of relevant work experience in industrial pharmaceutical or biotechnology CMC/cGMP environment

Experience with cGMP manufacturing and preparing CMC regulatory filings

Radiopharmaceutical experience highly preferred

Expertise in New Product Development and knowledge of Regulatory Affairs

Must have pharmaceutical industry experience with strong familiarity with cGMP, FDA, EMA, USP, NRC, and ICH guidelines

Responsibilities:

Support R&D initiatives and project teams by developing robust drug product formulations and processes

Design, synthesize, purify, and characterize drug candidates using a risk-based approach to drug development

Write technical documents for CMC regulatory submissions and provide peer reviews

Serve as the CMC functional area representative and Subject Matter Expert (SME) on development project teams

Ensure operational compliance with US and international regulatory agencies and guidelines (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC)

Additional Information:

Permanent position with a salary range of $125K-$150K plus 15% bonus

40-hour workweek from Monday through Friday; typical hours from 7am - 4pm EST