Lead Scientist, Analytical QC

TITLE:

Lead Scientist, Analytical QC

Title: Lead Scientist, Analytical QC

Reports To: Principal Scientist, Analytical QC

Location: Raleigh, NC

 

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

POSITION SUMMARY:

The QC Analytical Lead Scientist is a key position within the QC team supporting method transfer activities, and performing process improvement initiatives to support the laboratory testing as per USP and ICH guidelines. Method development, verification and validations will be required. This role will report to the Principal Scientist, Analytical QC while working in a collaborative team setting. This role is responsible for supporting and assisting with the delivery of project timelines and critical milestones. This role will be an inward and outward facing role working with contract testing labs as required. This role will also work in a manner that assures quality, safety, efficacy, and compliance to regulatory requirements.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

· Work with Contract Testing Laboratories (CTL) and ensure testing is completed in a timely manner. Participate in resolving technical issues, OOS results and the 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, as required.

· Support current and new product technology transfer to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and any additional studies related to Manufacturing.

· 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 documentation such as standard operation procedures for the QC Laboratory.

· Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes.

· Independently write and implement study protocols and reports.

· Keep accurate documentation as per current Good Manufacturing Practices (cGMP).

· Experience performing QC analyses with different instruments (wet chemistry, HPLC, GC, KF, FTIR, UV-VIS) is required.

· Perform analyses and peer reviews.

· Any other duties as determined by management to support the QC team.

MINIMUM QUALIFICATIONS:

· Bachelor’s Degree in a Scientific field from an accredited university required.

· Minimum ten (10) years of experience in the pharmaceutical industry required.

· Experience with method validation/verification/transfers required.

· Experience in performing instrument and software qualifications is preferred.

· Experience with USP, CFR