Lead Scientist - Analytical QC

1d1 day ago

Indivior

Raleigh, US · Full-time · $140,000 – $180,000

About this role

The QC Analytical Lead Scientist supports method transfer activities and process improvement initiatives for laboratory testing per USP and ICH guidelines. This role involves method development, verification, and validations. It reports to the Principal Scientist, Analytical QC in a collaborative team setting.

Work with Contract Testing Laboratories to ensure timely testing, resolve technical issues, OOS results, and review/approve CoAs. Support stability storage and testing in-house or at CTL. Assist with instrument qualifications, equipment repairs, preventative maintenance, and calibrations.

This inward and outward facing role collaborates with contract labs and internal teams to deliver project timelines and critical milestones. Indivior focuses on developing medicines for opioid use disorder as a global pharmaceutical company. The position assures quality, safety, efficacy, and regulatory compliance.

Support QC Laboratory start-up and transition to routine analytical testing. Facilitate technology transfers for current and new products to manufacturing sites. Contribute to OOS investigations, deviations, and corrective actions implementation.

Requirements

Experience supporting method transfer activities and process improvements in QC laboratories
Knowledge of USP and ICH guidelines for method development, verification, and validation
Proficiency in collaborating with contract testing laboratories on analytical testing
Background in stability testing and storage management for pharmaceuticals
Skills in OOS investigations, deviation handling, and corrective action implementation
Expertise in instrument qualification, calibration, and maintenance in GMP environments
Familiarity with technology transfer to manufacturing sites

Responsibilities

Work with Contract Testing Laboratories (CTL) and ensure testing is completed in a timely manner
Participate in resolving technical issues, OOS results and review/approve testing CoAs
Support stability storage and testing in house or at CTL
Support the start-up of the QC Laboratory and transition to routine analytical testing
Support product technology transfer by performing method verifications, validations, and transfers for the QC Laboratory
Assist in significant OOS investigations, deviations and ensure implementation of appropriate corrective actions
Perform and review instrument qualifications, equipment repairs, preventative maintenance calibrations
Author, revise, and implement laboratory documentation