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Form of workJob Description
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
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
