Manager, Formulation Development

Role Summary

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

Responsibilities

• 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.
• 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.
• 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, including timely investigation and closure of deviations and out-of-specifications; ensure CMC perspectives on Post-Approval Changes (PACs) with modifications to manufacturing processes, analytical methods, stability testing, and formulation, generating required supporting CMC information to support the change; and manage direct formulation and packaging technical relationships with 3rd party CROs/CDMOs as part of the outsourced CMC development model; work with other personnel to meet timelines and milestones.

Qualifications

• 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.

Education

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

Skills

• Formulation design and optimization
• Regulatory compliance (FDA, DEA)
• Analytical and problem-solving skills
• Technical writing and documentation
• Team leadership and mentoring
• Project management