Job Introduction

The Method Development Analyst is a highly skilled and detail-oriented individual. The primary responsibility of this role is to develop, validate and verify Quality Control analytical methods for the analysis of pharmaceuticals according to ICH and cGMP guidelines.

In this role the Analyst will design and conduct analytical tests, analyse, and interpret analytical data, and collaborate with cross-functional teams to meet projects deadlines in a timely manner.

With their strong analytical background, attention to details and good communication skills the Method Development Analyst can effectively communicate findings, recommendations, troubleshoot analytical issues, write validation protocols and reports. Must be familiar with regulatory general guidelines (FDA, ICH, USP) and related to analytical method validation.

Role Responsibility

• Develop and validate analytical HPLC and GC analytical methods for the analysis of drug substances and drug products.
• Write and execute validation protocols, according to regulatory (cGMP, ICH and VICH) guidelines.
• Troubleshoot and resolve analytical method issues, including method transfers, instrument problems and deviation from established protocols.
• Generate data analysis, processing and reports using Empower (LabSolutions preferred).
• Generate method validation reports, investigations reports, root cause analysis and conclusions.
• Collaborating with cross-functional teams to Identify analytical methods requirements.
• Maintain and troubleshoot analytical instruments especially HPLC, and other analytical instrumentations.
• Collaborate with external partners and contract analytical laboratories, as required for method development and validation activities.
• Peer-review analytical data and documentation for compliance to regulatory requirements (cGMP, GLP) and overall thoroughness.
• Stay up to date with regulatory requirements to ensure compliance.

The Ideal Candidate

• Skills in HPLC, GC, wet chemistry, data analysis and processing.
• Strong writing and communication skills.
• Analytical method development, validation, and method transfers.
• Able to write SOPs, protocols, and reports.
• OOS investigations.
• Knowledge of regulatory (FDA, ICH) guidelines.
• Familiarity with cGMP.
• Must have 5+ years of analytical method development experience in a cGMP environment.
• Must have 5 + years using HPLC (UV, PDA) RP, NP. Some GC experience is preferred. Instrument troubleshooting skills are also desired.
• Expertise in implementation of documentation and familiarity with GLP and GMP regulations.
• Ideally BS/MS in Chemistry or Biochemistry is preferred, but not mandatory.

Dechra Pharmaceuticals PLC