Manager, Formulation Development

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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 Formulation Development to lead the design, development, and optimization of drug formulations and packaging systems using a proactive Quality by Design (QbD) approach. This role is central to ensuring product quality, patient safety, regulatory compliance, and continuous improvement throughout the product lifecycle. Working within an outsourced development model, you will collaborate closely with internal partners and external organizations to move programs forward efficiently while maintaining high scientific and operational standards.

This role is for a formulation leader who wants their work to matter. You will play a key role in advancing therapies designed to treat Opiate Use Disorder work that directly impacts patients, families, and communities. You will lead formulation and packaging strategies from early concepts through clinical development and post-approval stages, bringing rigor, foresight, and care to every decision. If you enjoy solving complex problems, guiding teams, and building products that truly make a difference, this is a role where your expertise will be deeply valued.

HOW YOU’LL MAKE AN IMPACT

• Lead formulation and packaging development activities for new and existing drug product programs using a systematic QbD approach

• Design and optimize formulations with a focus on safety, stability, bioavailability, patient compliance, and manufacturability

• Oversee pre-formulation studies, feasibility assessments, and material compatibility evaluations

• Establish and evaluate relationships between formulation Critical Material Attributes and product Critical Quality Attributes (CQAs)

• Lead efforts to define design space and control strategies that support robust, scalable formulations

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

• Provide direct technical oversight of CROs and CDMOs supporting formulation and packaging activities

• Identify formulation and packaging risks early and implement mitigation strategies

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

• Support post-approval activities, including deviation investigation and resolution efforts, market inquiry responses, and formulation-related changes

WHAT YOU’LL BRING

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field (Master’s or PhD preferred)

• 6 to 8 years of experience in pharmaceutical formulation development

• Hands-on experience developing oral solid dosage forms, injectables, or long-acting formulations

• Strong understanding of formulation-related regulatory expectations, particularly for OUD therapies

• Experience working within cGMP environments and regulated development programs

• Proven ability to lead technically complex projects and guide external partners

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

• A structured, proactive working style with strong attention to detail

• Clear communication skills and the ability to collaborate and influence across disciplines and corporate hierarchy

• A leadership approach that supports mentoring, accountability, and shared success

WHY YOU’LL LOVE WORKING HERE

• Your work directly supports therapies addressing a critical public health need

• Leaders value preparation, sound judgment, and scientific integrity

• Teams collaborate openly and support one another across functions

• You will have ownership, influence, and room to grow as programs advance

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 REQUIREMENTS

• Individuals must follow aseptic gowning procedures and personal hygiene requirements for controlled areas, which includes removing all jewelry, makeup, and fragrances when necessary.

• Individuals must be physically capable of properly donning multiple layers of full-body PPE while using gowning benches and remaining active in a cleanroom for prolonged periods when necessary.

HOW WE INVEST IN OUR PEOPLE

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:

• Competitive PTO plus company closure from December 24th- January 1st

• 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

• Wellness programs as well as other discounts and perks

OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT

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.

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure

• 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: 

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure

• 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.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!

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.

Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.