Analytical R&D Director - Pharmaceutical / Nutraceutical

Contract Pharmacal Corp; Hauppauge (NY); Vor Ort; USD 105.000 - 150.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Analytical method development

Leadership and mentoring

Regulatory & quality awareness

Ausbildung

BS/MS/PhD in Chemistry or Pharmaceutical Sciences

Tools

HPLC/UPLC/LC-MS

ICP-GC instruments

Jobbeschreibung

Position Summary

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

• 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).

Salary Description

$105,000.00 - $150,000.00