Manager, Analytical Development

TITLE:

Manager, Analytical Development

WHO WE ARE

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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

Indivior is seeking a Manager of Analytical Development to lead the design, development, validation, and transfer of analytical methods that support drug product development and lifecycle management. This role is central to ensuring product quality, regulatory compliance, and smooth execution within an outsourced development model. You will apply an Analytical Quality by Design (AQbD) approach, partner closely with internal teams and external collaborators, and serve as a key analytical subject matter expert across development and post-approval activities.

This is a role for a leader who brings structure, clarity, and confidence to complex scientific work. You will guide analytical strategy from early development through clinical and post-approval stages, helping transform innovative therapies into reliable, high-quality medicines. You will be trusted to lead important decisions, collaborate across disciplines, and ensure analytical work is done right the first time. If you enjoy combining scientific rigor with thoughtful leadership and real impact, this is a place where your expertise will be valued.

HOW YOU’LL MAKE AN IMPACT

• Lead analytical development activities for new and existing drug product programs using a proactive AQbD approach aligned with ICH Q14 principles

• Design, optimize, validate, and transfer analytical methods that assess critical quality attributes and formulation relationships

• Contribute to drug product specifications and support stability strategy and expiration dating decisions

• Review analytical data, stability trends, and reports to ensure accuracy, robustness, and regulatory readiness

• Partner cross-functionally with Formulation Development, Regulatory Affairs, Clinical, Manufacturing, Supply, and Quality teams

• Provide direct technical oversight of CROs and CDMOs within an outsourced CMC development model

• Lead investigations, deviation resolution efforts, change controls, and root-cause assessments as needed

• Prepare clear, high-quality technical documentation, development reports, and regulatory submissions

• Support release testing and ongoing stability for clinical trial and commercial products

• Apply analytical expertise to post-approval changes, ensuring quality, safety, and efficacy are maintained

• Identify risks early, recommend mitigations, and continuously improve analytical strategies and processes

WHAT YOU’LL BRING

• A scientific degree, preferably in Chemistry or a closely related discipline

• At least 8 years of experience in pharmaceutical research, analytical development, or product development

• Strong working knowledge of analytical techniques, method validation, and pharmaceutical testing principles

• Hands-on experience working in cGMP and cGLP environments with FDA and global regulatory expectations

• Demonstrated success leading technically complex projects in fast-paced development settings

• Experience managing and collaborating with third-party CROs and CDMOs

• A proactive, organized approach with the ability to manage multiple priorities without losing sight of quality

• Clear, confident communication skills and the ability to build productive working relationships

• A results-driven mindset paired with sound scientific judgment and thoughtful risk evaluation

WHY YOU’LL LOVE WORKING HERE

• You will have real ownership and influence over analytical strategy and decision-making

• Leadership values expertise, preparation, and clear thinking over hierarchy

• Collaboration is genuine, with teams working together toward shared goals

• Your work directly supports therapies that make a meaningful difference

We are looking for someone who brings both technical depth and steady leadership. If that sounds like you, we would love to start the conversation.

PHYSICAL REQUIREM