QC Analytical Scientist

Indivior•Raleigh, NC

About The Position

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category. 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.

Requirements

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 in relevant laboratory, computer, and data analysis skills.
Strong organizational abilities, problem-solving skills, resourceful, and accountable.

Nice To Haves

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.
NMR experience is preferred but not required.

Responsibilities

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.

Benefits

3 weeks’ vacation plus floating holidays and sick leave
401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
U.S. Employee Stock Purchase Plan- 15% Discount
Comprehensive Medical, Dental, Vision, Life and Disability coverage
Health, Dependent Care and Limited Purpose Flex Spending and HSA options
Adoption assistance
Tuition reimbursement
Concierge/personal assistance services
Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
Gym, fitness facility and cell phone discounts