R&D Analytical Director — Lead Method Development

Contract Pharmacal Corp.; Hauppauge (NY); On-site; USD 105,000 - 150,000; Full time

Job summary

Contract Pharmacal Corp. in Hauppauge, NY, seeks a senior-level leader to orchestrate analytical development within AR&D, ensuring robust method development, validation, transfer, and investigations.

You will mentor scientists, oversee stability programs, and drive cross-functional alignment with Regulatory, QC, QA, and Project Management to meet CMC milestones. A strong background in chromatography and regulatory submissions is required.

Qualifications

• BS, MS, or Ph.D. in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Senior Manager: 8+ years of analytical development experience.
• Director level: 10+ years of progressive analytical development leadership.
• Experience supporting method development, validation, and regulatory submissions (CMC/ANDA).
• Experience leading or mentoring scientific teams preferred.

Responsibilities

• Act as a technical bridge between AR&D leadership and lab teams.
• Provide oversight for analytical method development, validation, transfer, and investigations.
• Ensure analytical deliverables meet schedule and project timelines.
• Prepare and review methods, protocols, reports, and regulatory documentation.
• Partner cross-functionally to support CMC and submission activities.
• Mentor scientists and promote a culture of quality and accountability.

Skills

Chromatography

LC-MS

GC-MS

UV-Vis

FTIR

Wet chemistry

Data integrity

FDA/ICH guidance

Technical writing

Leadership

Education

Chemistry/Pharmaceutical Sciences

Job description

Contract Pharmacal Corp. in Hauppauge, NY, seeks a senior-level leader to orchestrate analytical development within AR&D, ensuring robust method development, validation, transfer, and investigations.

You will mentor scientists, oversee stability programs, and drive cross-functional alignment with Regulatory, QC, QA, and Project Management to meet CMC milestones. A strong background in chromatography and regulatory submissions is required.