R&D Analytics Director, Pharma & Nutraceuticals

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

Job summary

Contract Pharmacal Corp (CPC) is seeking an analytical development leader to guide method development, validation, and transfer within the AR&D team in Hauppauge, NY. The role requires coordinating between leadership and bench scientists, ensuring compliant, inspection-ready deliverables aligned with business priorities.

The Sr. Manager/Director will mentor scientists, oversee stability programs, and drive cross-functional collaboration with Regulatory, QC, QA, and Project Management to meet CMC

Qualifications

• BS, MS, or Ph.D. in Chemistry, Pharmaceutical Sciences, or related field.
• Senior Manager: 8+ years in analytical development.
• Director level: 10+ years in analytical development with leadership responsibilities.
• Experience with method development, validation, and regulatory submissions (CMC/ANDA).

Responsibilities

• Lead design of method development, optimization, validation and transfers.
• Manage analytical testing such as assay, dissolution, impurities for formulation development.
• Author SOPs, validation protocols, reports, and specifications.
• Review and approve documents (SOPs, CoA, protocols, reports).
• Provide troubleshooting, root-cause analysis, and investigational planning.
• Mentor scientists and foster continuous improvement in the lab.
• Coordinate cross-functionally to meet CMC milestones across R&D, Regulatory, QC, QA, and PM.

Skills

Analytical method development

Leadership and mentoring

Regulatory & quality awareness

Education

BS/MS/PhD in Chemistry or Pharmaceutical Sciences

Tools

HPLC/UPLC/LC-MS

ICP-GC instruments

Job description

Contract Pharmacal Corp (CPC) is seeking an analytical development leader to guide method development, validation, and transfer within the AR&D team in Hauppauge, NY. The role requires coordinating between leadership and bench scientists, ensuring compliant, inspection-ready deliverables aligned with business priorities.

The Sr. Manager/Director will mentor scientists, oversee stability programs, and drive cross-functional collaboration with Regulatory, QC, QA, and Project Management to meet CMC