Analytical R&D Director - Pharmaceutical / Nutraceutical

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

Description

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.

• Job Type: Full-Time
• Location: Hauppauge, NY
• Level: Manager, Sr Manager, or Director
• Works Hours: Monday – Friday, 8:00AM – 4:00PM EST
• Pay Range: $105,000 - $150,000 per year, depending on experience and level
• Start Date: ASAP

What makes this role exciting

(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.

Why Join CPC?

At CPC, you’ll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on innovative problem-solving, and a collaborative culture. CPC offers an inclusive, respectful workplace with cutting-edge technologies serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions matter.

Requirements

Responsibilities

In this role, you will:

• 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.

Education & Experience

• 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).