Indivior · 16 hours ago
Manager, Analytical Development
Raleigh, NC
Full-time
Onsite
Mid, Senior Level, Lead/Staff
8+ years expIndivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). The Manager of Analytical Development will lead the design, development, and validation of analytical methods, ensuring product quality and regulatory compliance throughout the product lifecycle.
Addiction TreatmentBiotechnologyCommunitiesHealth CareMedicalPharmaceuticalSocial
Responsibilities
Lead analytical development activities for new drug product developments applying a systematic, proactive Analytical Quality By Design (AQbD) approach and using an outsourced development model. The AQbD 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 to ensure analytical methods are robust, reproducible, and regulatory-compliant throughout the product lifecycle. AQbD aligns with the principles outlined in ICH Q14
Design and optimize analytical methods to appropriately measure and to evaluate potential drug product Critical Quality Attributes (CQAs) and the relationship between formulation Critical Materials Attributes and the drug product Critical Quality Attributes (CQAs)
Contribute to the drug product specification development
Collaborate with cross-functional teams including Formulation Development, Regulatory Affairs, Clinical, and Manufacturing
Ensure adherence to cGMP, FDA, DEA, and other regulatory standards
Manages and plans the activities for AD analytical and microbiology testing
Conduct investigations, deviations and change controls as needed
Prepare technical documentation, including development reports, regulatory submissions, and presentations
Evaluate emerging technologies and scientific advancements to enhance analytical strategies
Interface with external partners, CDMOs, and academic collaborators to support development efforts
Identify and mitigate risks in formulation development projects
Review the emerging stability data and contribute to expiration dating for clinical trial supplies
Support the release testing of clinical trial supplies
Lead analytical method validation activities
Lead analytical method transfer activities
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:
Support timely and effective investigation and closure of deviations and out of specifications
Review the emerging ongoing stability data for compliance with registered specifications
Undertake analytical methods review and look for continuous improvement opportunities
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 analytical 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
Qualification
Required
A degree in Chemistry is preferred; Need a scientific degree
A minimum of 8 years of experience in the pharmaceutical product research or development is required
Pharmaceutical principles, practices and their application. Pharmaceutical and instrumental analyses and testing principles, techniques, applications and equipment
Experienced with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), Food and Drug Administration (FDA), and other regulatory requirements
Management of extremely technically challenging projects in a fast paced, GLP and GMP pharmaceutical development environment
Analyzing problems, projecting consequences of proposed actions, and implementing recommendations that support department goals and objectives
Planning, implementing goals, objectives and practices for effective, efficient and cost-effective management of allocated resources
Proven experience and practical knowledge in analytical development and/or QC
Experience of working with 3rd party partners to deliver project goals
Results orientated, self-motivated with an ability to evaluate and take risks
Strong analytical skills with the ability to think strategically to develop tactics and transform ideas into reality
Excellent communication skills and a proven ability to negotiate
Proven ability to work under pressure, as part of a team, without compromising quality and delivery
Communicating clearly and concisely, both orally and in writing. Establishing and maintaining effective working relationships with others. Managing and organizing multiple projects and assignments
Benefits
3 weeks’ vacation plus floating holidays and sick leave, 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
Company
Indivior
Indivior is a specialty pharmaceuticals business.
1001-5000 employees
H1B Sponsorship
Indivior has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (5)
2023 (5)
2022 (6)
2021 (4)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Piper SandlerOaktree Capital Management
2024-11-05Post Ipo Debt· $400M
2024-07-12Post Ipo Equity
2014-12-23IPO
Leadership Team
Mark Crossley
Chief Executive Officer
Recent News
2026-01-13
2026-01-09
Company data provided by crunchbase