Job Description

Director, Analytical Sciences & R&D

Kelly® Science & Clinical is seeking a Director, Analytical Sciences & R&D for a direct-hire position at a cutting-edge client in Irvine, CA . If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $150,000.00 to $175,000.00

Schedule: Full Time Onsite

Overview

This client is an industry-leading company that’s leading the way in pharmaceutical research and development. In this role, you will manage the analytical sciences group and the method development sub-group to support the development and troubleshooting of methods for all types of finished dosage forms. You will also address analytical issues, lead investigations, and ensure compliance with regulatory standards.

Responsibilities:

• Manage the analytical sciences and method development teams.
• Develop and troubleshoot methods for various finished dosage forms.
• Address analytical issues in FDA deficiency letters and draft responses.
• Write and review method validation and development protocols and reports.
• Conduct investigations into analytical testing result failures.
• Ensure compliance with cGMP regulations and SOPs.
• Collaborate with other departments to support analytical work.
• Review quality and technical activities for SOP/GMP compliance.
• Perform or assist with equipment calibrations and qualifications.
• Train and guide chemists in method development.
• Perform other related duties as required.

Qualifications:

• MS or Ph.D. in organic chemistry, analytical chemistry, pharmaceutical sciences, or a related field.
• 10+ years of experience in pharmaceutical ANDA & NDA development/analytical/CDMO labs.
• Small Molecule experience required.
• 8+ years of experience with analytical instrumentation (HPLC, GC, MS, ICP, etc.).
• Proven leadership and people management experience in an analytical group.
• Experience in FDA-regulated environments and compliance with State and Federal regulations.
• Extensive experience in HPLC method development and validation.
• Proficiency in MS Office and project management tools.
• Strong written and verbal communication skills.
• Ability to lead, organize, prioritize, and manage multiple tasks effectively.
• Strong attention to detail and a collaborative team mindset.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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