Job Description

Pharmaceutical R&D Director - Irvine, CA

Position Overview:

We are seeking an experienced R&D Director for a full-time position with a leading pharmaceutical client located in Irvine, CA. This role is perfect for someone passionate about leading research and development efforts focused on small molecule analytics and team management.

• Salary Range: $150,000 to $175,000 Annually, with a discretionary bonus component included.

• Schedule: Full-time employment, requiring flexibility to engage with client meetings and team leadership activities.

• Location: Irvine, CA. Candidates must be local; relocation is not considered due to the necessity of understanding local dynamics and the diverse demographic.

Position Summary:

The R&D Director will manage the analytical sciences group and method development sub-group, ensuring development and troubleshooting of methods for various finished dosage forms, while maintaining compliance with FDA and cGMP standards.

• Responsibilities: Team Management : Lead the analytical sciences group and method development sub-group.
• Development & Troubleshooting : Develop methods for various finished dosage forms; address analytical issues in FDA deficiency letters.
• Protocol Management : Write and review method validation/development protocols/reports.
• Research & Investigation : Conduct research and investigations into analytical testing failures.
• Interdepartmental Cooperation : Work with various departments to secure items needed for analytical work.
• Quality Assurance : Review activities to ensure compliance with SOPs and GMPs.
• Equipment Handling : Perform and assist with equipment calibrations and qualifications.
• Training & Mentorship : Train and guide chemists on method development techniques.
• Subject Matter Expertise : Serve as a SME in client meetings and contribute to team strategies.
• Additional Duties : Undertake related tasks as required.

Qualifications:

• Education : MS or Ph.D. in Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• Experience :
• 8+ years of hands-on experience in small molecule analytics.
• 10+ years in pharmaceutical ANDA NDA development/analytical/CDMO labs.
• Extensive experience with analytical instrumentation such as HPLC, GC, MS, ICP, etc.

Management Skills : Proven experience managing an analytical group, directing at least six direct reports.

FDA Regulations : Comprehensive understanding of FDA regulations.

Technical Skills : Expertise in method development/validation, proficiency with MS Office/project management tools.

Soft Skills : Strong communication, leadership, and organizational skills; effective team collaboration.

Highlights:

Candidates must possess a strong background in small molecules, demonstrating hands-on involvement in scientific processes to guide and contribute directly to R&D efforts.

What Happens Next:

Once you apply, our team will assess your skills and experience to determine if you’re a fit for the role. If this position doesn’t work out, you'll remain in our network, and our expert Science & Clinical recruiters will assist with future opportunities.

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