QC Analytical Scientist

TITLE:

Title:  QC Analytical Scientist

Reports To: QC Analytical Manager

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:

We are seeking a QC Analytical Scientist responsible for a unique opportunity to facilitate the startup of the GMP testing laboratory.  Candidates will conduct method transfers, method verifications/validations as per USP and ICH guidelines.  Some method development may be needed.  This role will report to the QC Analytical Manager and candidates will work in a collaborative team setting.  This role is responsible for supporting and assisting with the delivery of the project timeline and critical milestones. 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:

• Support the start-up the QC Laboratory and transition to routine analytical testing.
• Support technology transfer to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and any additional studies related to Manufacturing.
• Perform and review instrument qualifications and manage 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) required.
• Perform analyses and peer reviews.
• Identify and document deviations and conduct laboratory investigations.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in a Scientific field with minimum 3-5 years of experience in the pharmaceutical industry
• Experience with method validation/verification/transfers required.
• Experience performing instrument and software qualifications is preferred.
• Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred.
• Experience in relevant laboratory, computer, and data analysis skills.
• NMR experience is preferred but not required.
• Strong organizational abilities, problem-solving skills, resourceful, and accountable.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.
• Ability to handle a wide variety of tasks under critical time constraints.
• Ability to work independently and in a group setting, collaborative, self-motivated, proactive, and critical thinking.
• Ability to work varied schedule with some potential weekend, early morning, or late evening hours, if needed (seldom needed).