Manager, Formulation Development

TITLE:

Manager, Formulation Development

Title: Manager, Formulation Development

Reports To: Director, Product Development

Location: Raleigh, NC

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. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

POSITION SUMMARY:

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 it lifecycle, regulatory compliance, and alignment with company goals.

ESSENTIAL FUNCTIONS:

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 and using an outsourced development model. The QbD approach must utilize prior and scientific knowledge and be an iterative, systematic strategy integrating proactive risk assessment, emphasizing continuous improvement to mitigate potential quality issues early on.

o Design and optimize formulations considering stability, bioavailability, patient compliance, and manufacturing scalability to meet the desired Target Product Profile.

o Oversee pre-formulation studies, feasibility assessments, and compatibility evaluations.

o 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.

o Collaborate with cross-functional teams including Analytical Development, Regulatory Affairs, Clinical, and Manufacturing.

o Ensure adherence to cGMP, FDA, DEA, and other regulatory standards.

o Prepare technical documentation, including development reports, regulatory submissions, and presentations.

o Evaluate emerging technologies and scientific advancements to enhance formulation strategies.

o Interface with external partners, CDMOs, and academic collaborators to support development efforts.

o Identify and mitigate risks in formulation development projects.

· Post-Approval Drug Product Support – Apply prior knowledge and Subject Matter Expertise in partnership with Supply and Quality Assurance to support Indivior’s existing commercial drug products where applicable to include:

o Support timely and effective investigation and closure of deviations and out of specifications,

o 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. These changes may require regulatory approval, depending on their nature and potential impact on the drug product's quality, ensure that the required supporting CMC information (e.g., comparability assessment, a risk-based approach, etc) is generated to support the change.

· 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:

Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or related field (Ph.D. preferred).

Minimum 6–8 years of experience in pharmaceutical formulation development, ideally with exposure to controlled substances or CNS therapeutics.

Proven track record in developing oral solid dosage forms, injectables, or long-acting formulations.

Strong understanding of regulatory requirements for OUD-related products.

Excellent leadership, project management, and problem-solving skills.

Experience with DEA regulations and handling of Schedule II substances is a plus.

COMPETENCIES/CONDUCT:<