Manager, Analytical Development
Indivior
TITLE:
Manager, Analytical DevelopmentTitle: Manager, Analytical Development
Reports To: Director, Drug 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:
Manager of Analytical Development will lead the design, development, and validation of analytical methods. The role is critical in advancing innovative therapies from concept throughout clinical development, ensuring product quality throughout its lifecycle, regulatory compliance, and alignment with company goals.
ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:
· 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,
o 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).
o Contribute to the drug product specification development
o Collaborate with cross-functional teams including Formulation Development, Regulatory Affairs, Clinical, and Manufacturing.
o Ensure adherence to cGMP, FDA, DEA, and other regulatory standards.
o Manages and plans the activities for AD analytical and microbiology testing.
o Conduct investigations, deviations and change controls as needed.
o Prepare technical documentation, including development reports, regulatory submissions, and presentations.
o Evaluate emerging technologies and scientific advancements to enhance analytical strategies.
o Interface with external partners, CDMOs, and academic collaborators to support development efforts.
o Identify and mitigate risks in formulation development projects.
o Review the emerging stability data and contribute to expiration dating for clinical trial supplies.
o Support the release testing of clinical trial supplies.
o Lead analytical method validation activities.
o 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:
o Support timely and effective investigation and closure of deviations and out of specifications,
o Review the emerging ongoing stability data for compliance with registered specifications.
o Undertake analytical methods review and look for continuous improvement opportunities.
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 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.
MINIMUM QUALIFICATIONS:
· 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
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
· 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:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
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
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
COMPLIANCE OBLIGATIONS:
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations:
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Risk IQ: Know what policies apply to your role and function and adhere to them.
Speak Up: If you see something, say something.
Manager Obligations:
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled