Lead Chemist - Saint Louis, United States - Entegee

Description

Job Description

Job 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

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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.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

Company Description

Specializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.