End-to-End Chemical Drug Substance Development & CMC Experts
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End-to-End Chemical Drug Substance Development & CMC Experts
Imagine a leader who seamlessly navigates the complexities of drug development, ensuring quality, speed, and compliance. Look no further!
Deep Expertise: Leverage my extensive experience across all aspects – from QA (APIs, Drugs, Excipients) to Regulatory and GMP (US & EU).
Scientific Acumen: My in-depth knowledge of Analytical & Organic Chemistry (Biologics & Small Molecules) translates to efficient and successful drug development.
Process Optimization: I excel at developing multi-step pathways, optimizing processes, and troubleshooting discovery challenges, bringing drugs to market faster.
Project Management Prowess: Leading multi-site, multidisciplinary projects is my forte. I ensure successful execution by effectively allocating resources.
Team Builder & Mentor: I foster strong, development-oriented teams, nurturing talent and maximizing their potential.
Documented Success: Patents, publications, and awards – my track record speaks for itself.
cGMP Champion: I guarantee adherence to FDA/ICH regulations through audits and outsourcing expertise.
Additional Skills: Quality Risk Management, Remediation, Communication, Negotiation, and Leadership – I bring a comprehensive skillset to the table.
Education & Affiliations:
Earned a prestigious degree in chemistry from a recognized university (e.g., Ph.D. in Chemistry from State University of New York).
Member of the American Society for Quality (ASQ), Certified Quality Manager (CQM)).
Previous Experience:
Extensive experience working with leading pharmaceutical and biotechnology companies such as CoreRx, Inc. ,Pii (Pharmaceutics International, Inc.), Centrose, LLC.
Ready to drive innovation and accelerate drug development? Schedule a free Consultation Now.