Manager, Formulation Development

Manager, Formulation 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. Visit www.indivior.com to learn more.

The Manager, Formulation Development will lead the design, development, and optimization of drug formulations specifically targeting Opiate Use Disorder (OUD). This role is critical in advancing innovative therapies from concept through clinical development, ensuring product quality throughout the lifecycle, regulatory compliance, and alignment with company goals.

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

• Lead formulation and packaging development activities for new drug product developments applying a systematic, proactive Quality By Design (QbD) approach.
• Design and optimize formulations considering stability, bioavailability, patient compliance, and manufacturing scalability to meet the desired Target Product Profile.
• Oversee pre-formulation studies, feasibility assessments, and compatibility evaluations.
• Ensure the relationship between formulation Critical Materials Attributes and the drug product Critical Quality Attributes (CQAs) are established, evaluated in terms of design space and appropriately controlled as part of the overall control strategy.
• Collaborate with cross-functional teams including Analytical Development, Regulatory Affairs, Clinical, and Manufacturing.
• Ensure adherence to cGMP, FDA, DEA, and other regulatory standards.
• Prepare technical documentation, including development reports, regulatory submissions, and presentations.
• Evaluate emerging technologies and scientific advancements to enhance formulation strategies.
• Interface with external partners, CDMOs, and academic collaborators to support development efforts.
• Identify and mitigate risks in formulation development projects.
• Support timely and effective investigation and closure of deviations and out of specifications.
• 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 formulation and packaging 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 :

Competencies / Conduct :

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