Methods Development Analyst
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.
The position of Method Development Analyst reports to the Method Validation Manager
- 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.
Key Performance Indicators
- Write validation protocols in a timely manner, reflecting all the necessary regulatory requirements.
- Percentage of the method validation, optimization and transfers conducted successfully.
- Successfully delivering validated analytical methods within the required timelines.
- Quality and thoroughness of the analytical data provided in the validation reports.
- Communication skills and ability to clearly present analytical findings to peers and management.
The Ideal Candidate
BS in Chemistry or Biochemistry, MS is preferred
5 + years experience using HPLC and of analytical method development.
2 + years of experience with GMP.
Competitive + Benefits
Dechra Pharmaceuticals PLC