Director Analytical Research & Development - CDMO

Randstad USA; High Point (NC); On-site; USD 178,000 - 200,000; Full time

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.

Skills

Analytical chemistry

Leadership

cGMP compliance

Budgeting

Education

Ph.D. in Chemistry

M.S. in Chemistry

B.S. in Chemistry

Job description

Job Summary

Lead groundbreaking small-molecule API drug substance development onsite near High Point, NC! A top-tier global pharmaceutical CDMO is seeking a Director of Analytical Research & Development to drive analytical operations, lead high-performing scientific teams, and act as the principal technical subject matter expert for key clients in a fast-paced cGMP environment.

location: High Point, North Carolina

job type: Permanent

salary: $178,000 - 200,000 per year

work hours: 9 to 5

education: Masters

Responsibilities

• Direct and mentor Analytical Associate Directors and scientific staff, managing departmental resources, project workflows, and site execution timelines.
• Serve as the primary technical client liaison and subject matter expert for small-molecule API analytical development.
• Oversee analytical project quoting, budgeting, invoicing, contract discussions, and resource reconciliation.
• Ensure strict adherence to global regulatory guidelines (FDA, ICH, USP, EP, JP) and cGMP standards.
• Partner with executive site leadership across Chemical Development and Quality to guide long-range business planning and site strategy.

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.

skills: Chemistry, Active Pharmaceutical Ingredient (API)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.