Senior GMP Analytical Method Developer & Validator

Alaron; Nelson; On-site; GBP 39,000 - 57,000; Full time

Job summary

Alaron Products Limited, based in Nelson, New Zealand, seeks an experienced Method Development and Validation Scientist/Engineer to join its analytical team. The role focuses on developing, validating and transferring robust methods to support compliant QC testing in a regulated manufacturing environment.

You will work across platforms including UPLC/HPLC, NIR, FTIR, UV/Vis, LC-MS/MS and ELISA, contributing to method lifecycle documentation, risk assessments and change controls while helping to

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Science or related field.
• Typically 5+ years' experience in analytical development, validation, transfer or QC.
• Experience designing protocols, evaluating validation characteristics and writing technical reports.

Responsibilities

• Develop, optimise, document and maintain analytical methods for raw materials, in-process, stability and finished products.
• Analytical method validation.
• Prepare, execute and report method verification, validation, transfer and implementation protocols in accordance with GMP.
• Work across analytical platforms including UPLC/HPLC, NIR, FTIR, UV/Vis, LC-MS/MassSpec, ELISA, microbiological and compendial methods.
• Troubleshoot method performance, matrix interference, sample preparation and instrument issues.
• Maintain method lifecycle documentation, technical rationales, risk assessments, change controls and performance monitoring.
• Transfer approved methods into routine QC, including analyst training and competency support.
• Support the introduction and implementation of new analytical techniques and laboratory capability.
• Support routine QC testing, analytical review, OOS/OOT investigations and technical troubleshooting as required.

Skills

Analytical development

Troubleshooting

Technical documentation

Data integrity

Education

Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Science or related field

Tools

UPLC/HPLC

NIR

FTIR

UV/Vis

LC-MS

ELISA

Job description

Alaron Products Limited, based in Nelson, New Zealand, seeks an experienced Method Development and Validation Scientist/Engineer to join its analytical team. The role focuses on developing, validating and transferring robust methods to support compliant QC testing in a regulated manufacturing environment.

You will work across platforms including UPLC/HPLC, NIR, FTIR, UV/Vis, LC-MS/MS and ELISA, contributing to method lifecycle documentation, risk assessments and change controls while helping to