QC Analytical Scientist

TITLE:

QC Analytical Scientist

Title: QC Analytical Scientist

Reports To: QC Analytical Manager

Location: 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 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.

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).

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 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

GUIDING PRINCIPLES:

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

COMPLIANCE OBLIGATIONS:

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:

Employee Obligations:

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

Manager Obligations:

• 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.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled