Method Development & Validation Analyst
Basic Role Summary:
This role offers a unique opportunity to be an analytical method development scientist within a dynamic pharmaceutical RD Medical team. You will be instrumental in supporting Chanelle Pharma's vision to be the most valued global provider of high-quality, competitively priced pharmaceutical products while delivering excellent technical support to customers and stakeholders.
As a Method Development Validation Analyst, you will take ownership of stability-indicating method (SIM) development, method validation studies, and nitrosamine impurity testing, ensuring all analytical methods meet ICH Q2(R2) guidelines and regulatory expectations. This is a hands-on analytical chemistry role requiring strong technical competence, attention to data integrity, and the ability to troubleshoot complex chromatographic challenges.
Location
Onsite at our facility in Loughrea.
As our Method Development Validation Analyst, your key responsibilities will include:
Lead or co-lead development of stability-indicating methods (assay, related substances, preservatives, cleaning methods) for pipeline products, including forced degradation studies and impurity characterization.
Execute analytical method validation studies in accordance with ICH Q2(R2) guidelines and prepare comprehensive validation protocols and final reports.
Develop and validate nitrosamine impurity test methods in line with ICH M7 recommendations and regulatory expectations (FDA, EMA), maintaining knowledge of evolving nitrosamine guidance.
Troubleshoot method failures and optimize chromatographic conditions to achieve robustness, sensitivity, and selectivity targets.
Perform forced degradation studies on active ingredients and reference materials to characterize degradation pathways and support SIM design.
Document validated methods, prepare standard operating procedures (SOPs), and transfer methods to QA/Production as required.
Execute analytical testing of laboratory trial samples and development batches according to agreed timelines and specifications.
Characterize active pharmaceutical ingredients (APIs) and reference materials for proposed medical products.
Conduct stability testing of medical products in accordance with stability protocols (lab trials, pilot batches) and prepare stability reports in line with ICH Q1A/Q1B requirements.
Perform process validation testing and support manufacturing process qualification activities.
Maintain the RD analytical laboratory to GMP standards and ensure compliance during internal audits and inspections.
Complete and maintain laboratory notebooks and experiment registers to ensure traceability and data integrity.
Ensure timely availability of analytical standards, chromatographic columns, and reagents to prevent testing delays.
Review and verify analytical RD raw data associated with method validation, process validation, trial batches, and stability studies.
Manage filing and organization of analytical RD records and external testing results, distributing findings to relevant stakeholders.
Coordinate shipment of validation and stability samples to contract laboratories and track external testing results.
Support internal and external audits, including client audits and regulatory inspections, and respond to audit findings related to analytical methods.
Identify and implement opportunities to improve analytical laboratory efficiency, including lean initiatives and method simplification.
Research and implement improvements to analytical method robustness and laboratory efficiency.
Liaise with Quality Assurance, Formulation Development, and Operations teams to address technical queries and support cross-functional projects.
Train and mentor junior analytical staff on method development principles, analytical instrumentation, and data integrity best practices.
Conduct cleaning validation studies for RD products when required.
Carry out other duties as assigned by the RD Manager or team leadership.
Qualifications and Experience
Bachelor's degree (or higher) in Analytical Chemistry, Pharmaceutical Chemistry, Chemistry, Pharmaceutical Sciences, or a related life science discipline.
5+ years of hands-on experience in analytical method development, validation, or quality control within a GMP pharmaceutical, biotechnology, or contract research organization (CRO) environment.
Demonstrated proficiency in HPLC method development and troubleshooting.
5+ years of experience in analytical method development, preferably involving pipeline or developmental pharmaceutical products.
Experience with nitrosamine testing method development and impurity profiling.
Hands-on experience with LC-MS or other advanced chromatographic techniques.
Previous involvement in method transfer, validation report writing, and preparation for regulatory submissions.
Experience with pharmaceutical stability testing under ICH conditions and stability reporting.
Familiarity with Empower or similar analytical software platforms and LIMS.
Skills and Competencies
Hands-on expertise in HPLC/UPLC method development, optimization, and troubleshooting.
Strong understanding of ICH Q2(R2) analytical method validation requirements, including accuracy, precision, linearity, range, robustness, and specificity.
Knowledge of stability testing protocols and interpretation in line with ICH Q1A/Q1B and Q1D requirements.
Experience conducting forced degradation studies, impurity characterization, and related substances analysis.
Familiarity with nitrosamine testing methodologies and evolving ICH M7 guidance.
Experience using analytical instrumentation software such as Empower and laboratory information management systems (LIMS).
Knowledge of additional analytical techniques including GC, LC-MS, and thermal analysis.
Working knowledge of GMP regulations, including ICH Q7 and EU GMP Annex 15 for analytical validation.
Familiarity with EMA and FDA guidance documents related to analytical procedures and method validation.
Strong understanding of data integrity principles and maintenance of compliant laboratory records in accordance with ALCOA+ principles.
Experience supporting regulatory inspections and responding to audit observations relating to analytical methods.
Excellent technical writing and report preparation skills for validation reports, stability reports, and SOPs.
Strong attention to detail with a commitment to data integrity and analytical accuracy.
Ability to work independently, manage multiple projects, and meet tight deadlines.
Excellent interpersonal and communication skills with the ability to collaborate effectively across Quality Assurance, Formulation, and Manufacturing functions.
Proactive problem-solving mindset and willingness to research and adopt new analytical techniques.
Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.
Commitment to health, safety, and laboratory compliance, including appropriate PPE use, maintaining a safe work environment, and adherence to company health and safety procedures.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
