CMC Analytical Research & Development Scientist

About Warwick Consulting

Warwick Consulting LLC is a leading provider of quality, regulatory, engineering, and product development solutions to the medical device industry. We support clients across the entire product lifecycle—from early-stage research and development through commercialization—with expertise in design controls, software engineering, systems engineering, cybersecurity, risk management, quality assurance, and regulatory compliance. With a proven track record across more than 25 therapeutic areas and over 35 commercialized medical devices, Warwick Consulting partners with global medical technology organizations to accelerate innovation while ensuring regulatory excellence.

Position Summary

Warwick Consulting is seeking a motivated CMC Analytical Research & Development Scientist to perform hands-on analytical method development, validation, verification, troubleshooting, and GMP/QC laboratory support for drug substance and drug product programs. The ideal candidate can work independently on method development and validation activities, generate reliable GMP-compliant data, and use Waters Empower proficiently for chromatographic data acquisition, processing, review, and reporting.

Key Responsibilities

1.    Analytical Method Development & Validation

·      Independently develop, optimize, validate/verify analytical methods for raw materials, intermediates, drug substances, drug products, and medical devices.

·      Execute method development and validation experiments using scientifically sound and GMP-compliant approaches.

·      Prepare and execute method development plans, validation or verification protocols, and related study designs.

·      Troubleshoot chromatographic, spectroscopic, physicochemical, and compendial methods, including system suitability and method performance issues.

2.    GMP Analytical & QC Support

·      Perform analytical testing and support method implementation in GMP Analytical and QC environments.

·      Support release, stability, in-process, raw material, and development sample testing as needed.

·      Use Waters Empower independently for chromatographic data acquisition, processing, integration, review, reporting, and troubleshooting.

·      Ensure data integrity and compliance during analytical execution, documentation, and review activities.

3.    Stability, Investigations & Lifecycle Support

·      Support stability studies and analytical lifecycle activities, including stability-indicating methods, data review, trending, troubleshooting, and root cause analysis.

Qualifications

1.    Required Qualifications

·      B.S., M.S. or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline with 3-8 years of relevant industry experience.

·      Must have 3–5 years of hands-on analytical method development and method validation experience in GMP Analytical and/or QC laboratory environments.

·      Must be a well-experienced Waters Empower user with the ability to independently perform data acquisition, processing, integration, review, reporting, and chromatographic troubleshooting.

·      Hands-on experience with HPLC and related analytical techniques; experience with GC, UV/Vis, FTIR, Karl Fischer, or wet chemistry is a plus.

·      Working knowledge of GMP documentation, data integrity practices, ICH method validation expectations, and applicable compendial guidance.

·      Strong organization, attention to detail, scientific judgment, problem-solving skills, and ability to communicate results clearly.

2.    Preferred Qualifications

·      Experience with stability-indicating method development/validation, polymers or combination products, or external laboratory/CRO/CDMO testing support.