Manager, Analytical Development

Indivior•Raleigh, NC

18h

About The Position

Indivior is seeking a Manager of Analytical Development to lead the design, development, validation, and transfer of analytical methods that support drug product development and lifecycle management. This role is central to ensuring product quality, regulatory compliance, and smooth execution within an outsourced development model. You will apply an Analytical Quality by Design (AQbD) approach, partner closely with internal teams and external collaborators, and serve as a key analytical subject matter expert across development and post-approval activities. This is a role for a leader who brings structure, clarity, and confidence to complex scientific work. You will guide analytical strategy from early development through clinical and post-approval stages, helping transform innovative therapies into reliable, high-quality medicines. You will be trusted to lead important decisions, collaborate across disciplines, and ensure analytical work is done right the first time. If you enjoy combining scientific rigor with thoughtful leadership and real impact, this is a place where your expertise will be valued.

Requirements

A scientific degree, preferably in Chemistry or a closely related discipline
At least 8 years of experience in pharmaceutical research, analytical development, or product development
Strong working knowledge of analytical techniques, method validation, and pharmaceutical testing principles
Hands-on experience working in cGMP and cGLP environments with FDA and global regulatory expectations
Demonstrated success leading technically complex projects in fast-paced development settings
Experience managing and collaborating with third-party CROs and CDMOs
A proactive, organized approach with the ability to manage multiple priorities without losing sight of quality
Clear, confident communication skills and the ability to build productive working relationships
A results-driven mindset paired with sound scientific judgment and thoughtful risk evaluation

Responsibilities

Lead analytical development activities for new and existing drug product programs using a proactive AQbD approach aligned with ICH Q14 principles
Design, optimize, validate, and transfer analytical methods that assess critical quality attributes and formulation relationships
Contribute to drug product specifications and support stability strategy and expiration dating decisions
Review analytical data, stability trends, and reports to ensure accuracy, robustness, and regulatory readiness
Partner cross-functionally with Formulation Development, Regulatory Affairs, Clinical, Manufacturing, Supply, and Quality teams
Provide direct technical oversight of CROs and CDMOs within an outsourced CMC development model
Lead investigations, deviation resolution efforts, change controls, and root-cause assessments as needed
Prepare clear, high-quality technical documentation, development reports, and regulatory submissions
Support release testing and ongoing stability for clinical trial and commercial products
Apply analytical expertise to post-approval changes, ensuring quality, safety, and efficacy are maintained
Identify risks early, recommend mitigations, and continuously improve analytical strategies and processes

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
Gym, fitness facility and cell phone discounts