QC Analytical Scientist

Title

QC Analytical Scientist

QC Analytical Manager

Raleigh, NC

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 company’s mission is to transform addiction from a global human crisis to a recognized and treated chronic disease, providing evidence‑based treatment for patients worldwide. Building on its portfolio of opioid use disorder treatments, Indivior has a pipeline of products designed to 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. Responsibilities include conducting method transfers, verifications, validations, and potential method development, supporting project timelines and critical milestones in a collaborative team setting, and ensuring quality, safety, efficacy, and regulatory compliance.

• Support the startup of the QC Laboratory and transition to routine analytical testing.
• Transfer technology to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and related manufacturing studies.
• Perform and review instrument qualifications and manage calibrations.
• Author, revise, and implement documentation such as standard operating procedures for the QC Laboratory.
• Evaluate test methods and adapt processes for commercial purposes.
• Write and implement study protocols and reports independently.
• Maintain accurate documentation as per cGMP.
• Perform QC analyses with instruments including wet chemistry, HPLC, GC, KF, FTIR, and UV‑VIS.
• Conduct analyses and peer reviews.
• Identify deviations and conduct laboratory investigations.

• Bachelor’s degree in a scientific field with 3–5 years of pharmaceutical industry experience.
• Experience with method validation, verification, and transfer.
• Experience with instrument and software qualification.
• Familiarity with USP, CFR, ICH, ISO regulations, and QbD principles.
• Laboratory, computer, and data analysis skills.
• Preferred: NMR experience.
• Strong organizational, problem‑solving, resourceful, and accountable skills.

• Knowledge of quality system methodologies such as FMEA, Pareto analysis, and Six Sigma concepts.
• Ability to handle a wide variety of tasks under critical time constraints.
• Independence and teamwork, self‑motivation, proactivity, and critical thinking.
• Flexibility to work varied schedules, with occasional weekend, early morning, or late evening hours.

• Three weeks’ vacation plus floating holidays and sick leave.
• 401(k) and profit‑sharing plan with company match and profit‑sharing contribution.
• U.S. Employee Stock Purchase Plan with 15% discount.
• Comprehensive medical, dental, vision, life, and disability coverage.
• Health and dependent‑care 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.

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to these principles in everyday performance.

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities you are expected to act with honesty and integrity, know applicable policies, and speak up when you see something.

• Always act with honesty and integrity.
• Know what policies apply to your role and function and adhere to them.
• Speak up:
  If you see something, say something.

• Always act with honesty and integrity.
• Reinforce risk awareness with your team with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EOE/Minorities/Females/Vet/Disabled