Method Development & Validation Analyst

Chanelle Pharma; Loughrea; On-site; EUR 65,000 - 90,000; Full time

Job summary

Chanelle Pharma in Ireland seeks an experienced Analytical Method Development & Validation Analyst to lead SIM development, validation studies and nitrosamine testing within a GMP environment.

You will own method transfer, troubleshooting, stability testing, and support audits while mentoring junior staff and collaborating across QA, Formulation and Manufacturing.

Qualifications

• Bachelor's degree in Analytical/Chemical Sciences or related field.
• 5+ years hands-on analytical method development/validation in GMP pharma/biotech/CRO.
• Proficient in HPLC method development and troubleshooting.
• Experience with nitrosamine testing and impurity profiling.
• Hands-on with LC-MS or similar chromatographic techniques.

Responsibilities

• Lead or co-lead SIM method development and validation for pipeline products.
• Develop and validate nitrosamine impurity test methods per ICH M7.
• Troubleshoot method failures and optimize chromatographic conditions.
• Prepare validation protocols and final reports for regulatory submissions.
• Train and mentor junior analytical staff and transfer methods to QA/Production.

Skills

HPLC/UPLC method development

ICH Q2(R2) validation

Data integrity (ALCOA+)

Troubleshooting chromatography

LC-MS handling

Empower software

LIMS familiarity

Education

Bachelor's degree in Analytical/Chemical science

Tools

Empower

LIMS

Job description

Basic Role Summary:

This role offers a unique opportunity to be an analytical method development scientist within a dynamic pharmaceutical R&D 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 R&D 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 R&D raw data associated with method validation, process validation, trial batches, and stability studies.
• Manage filing and organization of analytical R&D 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 R&D products when required.
• Carry out other duties as assigned by the R&D 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.