Director of Analytical R&D - Small-Molecule API

Randstad USA

High Point (NC)

On-site

USD 178,000 - 200,000

Full time

6 days ago

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Job summary

Randstad is seeking a Director of Analytical Research & Development to lead groundbreaking small-molecule API analytical development onsite near High Point, NC. This permanent role drives analytical operations, leads high-performing scientific teams, and serves as the principal technical SME for key clients in a fast-paced cGMP environment.

The role requires senior-level expertise in analytical techniques and regulatory compliance, with a track record of managing budgets, timelines, and

Qualifications

Ph.D. with 10+ years, M.S. with 15+ years, or B.S. with 20+ years of pharmaceutical chemical process development experience.
Proven leadership and direct management experience in a cGMP pharmaceutical R&D or manufacturing setting.
Deep expertise in small-molecule analytical techniques (HPLC, GC, LC/GC-MS, IR) and handling Out-of-Specification (OOS) investigations.
Advanced knowledge of compendial methods, SOP development, and regulatory compliance.

Responsibilities

Direct and mentor Analytical leadership, manage resources, workflows, and timelines.
Serve as primary technical client liaison and SME for small-molecule API analytical development.
Oversee analytical project quoting, budgeting, invoicing, contract discussions, and resource reconciliation.
Ensure adherence to FDA, ICH, USP, EP, JP and cGMP standards.
Partner with site leadership to guide long-range business planning and site strategy.