Analytical R&D Director - Pharmaceutical / Nutraceutical

CONTRACT PHARMACAL CORP•Town of Smithtown, NY

6d•Onsite

About The Position

We are looking to grow our AR&D team here at CPC. We are seeking those who thrive at the intersection of science, leadership, and execution - connecting AR&D leadership and laboratory scientists, ensuring analytical development work is technically sound, clearly documented, inspection-ready, and aligned with business priorities. You'll bring analytical expertise, strong technical writings skills, and leadership mindset that elevates both people and programs.

Requirements

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.
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).

Nice To Haves

Experience in leading or mentoring scientific teams strongly preferred.

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.
Act as a technical and operational bridge between AR&D leadership and laboratory teams.
Provide scientific oversight for analytical method development, validation, transfer, and investigations.
Ensure analytical deliverables are executed on schedule and aligned with overall project timelines and business priorities.
Prepare and review methods, protocols, reports, and regulatory-facing documentation.
Partner cross-functionally to support CMC and submission-enabling activities.
Help translate strategy into clear priorities, timelines, and execution.
Mentor scientists, strengthen technical rigor, and reinforce a culture of quality and accountability.