Manager, Formulation Development

Indivior • Raleigh, NC

1d

About The Position

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.

Requirements

• 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

Nice To Haves

• Master’s or PhD preferred

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager