Analytical R&D Director - Pharmaceutical / Nutraceutical

Responsibilities

• Lead the design of method development, optimization, and validation of robust stability-indicating methods including methods transfer.
• Manage, prioritize, and monitor critical analytical testing such as assay, content uniformity, dissolution, blend uniformity, and impurities in support of formulation development utilizing various analytical instruments and software such as HPLC, UPLC, UPLC-MS/MS, ICP,ICP-MS/MS GC, GC-MS/MS, FTIR, and UV-Vis.
• Manage all aspects of AR&D stability programs, analysis, testing strategies, and trending.
• Engage in authoring SOPs, method validation protocols and reports, and specifications (Raw Materials and FPs).
• Review and approve documents (SOPs, CoA, protocols, reports, etc.).
• Provide guidance for technical troubleshooting, investigate failures, root cause analysis, and plan investigational studies.
• Participate in personnel selection process and evaluate performance.
• Mentor and provide technical leadership to scientists, foster skill development, and promote a culture of continuous improvement within the laboratory.
• Serve as the point of contact for internal and external stakeholders, driving clear communication, and cross-functional alignment across R&D formulation, Regulatory, QC, QA, and Project Management to achieve CMC milestones.

Qualifications

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

Skills, Knowledge & Abilities

• Broad, working knowledge of analytical techniques, including chromatography (HPLC, UPLC, LC-MS, GC, GC-MS, ICP-OES/MS, TLC/HPTLC), spectroscopy (UV-Vis, FTIR), and classical/wet chemistry.
• Strong understanding of cGMP, data integrity principles, FDA and ICH guidelines.
• Exceptional technical writing skills with the ability to produce clear and concise documentation.
• Ability to translate complex scientific concepts for both technical and non-technical stakeholders.
• Proven leadership skills with the ability to influence without authority and bridge leadership and bench-level execution.
• Strong organizational, prioritization, project management, communication and problem-solving capabilities.
• Proficiency with standard business and documentation tools (e.g., Microsoft Office).