Lead Chemist - Entegee

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

 

 

 

 

Pay Details: $80,000.00 to $120,000.00 per hour

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.