Analytical Services Manager: GMP QC & Development Lead

Cambrex Corp.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Cambrex Corp. in Durham, NC seeks an Analytical Services Manager to lead a growing team supporting both development and QC workflows for drug substances and drug products. You will provide strategic direction, project planning, and client oversight to ensure timely, compliant results in a fast-paced setting.

Experience with LC-MS/MS and method validation is required, along with strong leadership, problem-solving, and a commitment to quality and safety.

Qualifications

• 2+ years of management experience in a quality laboratory environment.
• Strong analytical chemistry knowledge with ability to assess CQA gaps in DS and DP control strategies.
• cGMP knowledge with experience in RCA.
• Strong familiarity with instrument operation and troubleshooting.
• Supports Lean 6S principles and Lean Labs implementation.
• Experience identifying discrepancies, authoring out-of-spec and deviation investigations, and supporting CAPAs.
• Experience supporting manufacturing operations is beneficial.

Responsibilities

• Provide strategic oversight and operational direction for a cross‑trained team of analytical scientists.
• Oversee daily prioritization of GMP and non‑GMP projects, including scheduling staff and equipment, and productivity assessments.
• Develop and validate analytical methods; troubleshoot issues during development.
• Supervise laboratory and non‑laboratory staff; provide feedback and evaluations.
• Ensure test methods, validation reports, stability protocols, and development reports align with SOPs and ICH/FDA guidelines.
• Support talent growth and hire top performers; back up testing and data review as needed.
• Collaborate cross‑functionally with other departments to meet client objectives and drive quality culture.

Skills

Analytical chemistry

Problem solving

Team leadership

GMP/ICH knowledge

Instrument troubleshooting

Lean Labs

Project coordination

Education

BS, MS, or PhD in Chemistry or related field

Tools

HPLC/UPLC

FT-IR

GC-FID/MS

cKF

Job description

Cambrex Corp. in Durham, NC seeks an Analytical Services Manager to lead a growing team supporting both development and QC workflows for drug substances and drug products. You will provide strategic direction, project planning, and client oversight to ensure timely, compliant results in a fast-paced setting.

Experience with LC-MS/MS and method validation is required, along with strong leadership, problem-solving, and a commitment to quality and safety.