Manager, Analytical Development

Manager, Analytical Development

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.

POSITION SUMMARY :

Manager of Analytical Development will lead the design, development, and validation of analytical methods. The role is critical in advancing innovative therapies from concept throughout clinical development, ensuring product quality throughout its lifecycle, regulatory compliance, and alignment with company goals.

ESSENTIAL FUNCTIONS :

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

• Lead analytical development activities for new drug product developments applying a systematic, proactive Analytical Quality By Design (AQbD) approach and using an outsourced development model.
• Design and optimize analytical methods to appropriately measure and to evaluate potential drug product Critical Quality Attributes (CQAs) and the relationship between formulation Critical Materials Attributes and the drug product Critical Quality Attributes (CQAs).
• Collaborate with cross-functional teams including Formulation Development, Regulatory Affairs, Clinical, and Manufacturing.
• Ensure adherence to cGMP, FDA, DEA, and other regulatory standards.
• Manages and plans the activities for AD analytical and microbiology testing.
• Conduct investigations, deviations, and change controls as needed.
• Prepare technical documentation, including development reports, regulatory submissions, and presentations.
• Evaluate emerging technologies and scientific advancements to enhance analytical strategies.
• Interface with external partners, CDMOs, and academic collaborators to support development efforts.
• Identify and mitigate risks in formulation development projects.
• Review the emerging stability data and contribute to expiration dating for clinical trial supplies.
• Support the release testing of clinical trial supplies.
• Lead analytical method validation activities.
• Lead analytical method transfer activities.
• Support timely and effective investigation and closure of deviations and out of specifications.
• Review the emerging ongoing stability data for compliance with registered specifications.
• Undertake analytical methods review and look for continuous improvement opportunities.
• Ensure from a CMC perspective the consistent quality, safety, and efficacy of the drug product during Post-Approval Changes (PACs) that include modifications to the manufacturing processes, analytical methods, stability testing, and formulation.
• Responsible for the direct analytical technical management of the 3rd party contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) as part of the outsourced CMC development model.
• Work effectively with other personnel throughout the company to meet timelines and milestones.

MINIMUM QUALIFICATIONS :

A degree in Chemistry is preferred; Need a scientific degree

A minimum of 8 years of experience in the pharmaceutical product research or development is required

Pharmaceutical principles, practices and their application. Pharmaceutical and instrumental analyses and testing principles, techniques, applications and equipment

COMPETENCIES / CONDUCT :

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

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 :

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 behavior. As part of your responsibilities, you are expected to :

Manager Obligations :

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