Director, Product Development

TITLE:

Director, Product Development

Title: Director, Product Development

Reports To: VP, CMC Operations

Location: Raleigh

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:

Responsible for all aspects of the Chemistry, Manufacturing, and Controls (CMC) Drug Product Development including:

· New drug product development projects – Analytical, formulation, packaging, and process development applying a systematic, proactive Quality By Design (QbD) approach and using an outsourced development model. The QbD approach must utilize scientific knowledge and risk management to identify and mitigate potential quality issues early on.

· New drug product development projects – The manufacture and supply of clinical supplies.

· 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 to include:

o Support timely and effective investigation and closure of deviations and out of specifications,

o Review the emerging ongoing stability data review for compliance with registered specifications

o Set up and undertake Continuous Process Verification (CPV) which is the science and risk-based real-time approach to verify and demonstrate that Indivior’s manufacturing processes operate within the predefined specified

parameters consistently produces material which meets all its critical quality attributes (CQAs) and control strategy requirements.

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 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.

· Responsible for the direct supervision and development of other team members, including training, guidance, and mentoring on a formal and informal basis.

· Work effectively with other personnel throughout the company to meet timelines and milestones.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following: attend regularly scheduled CMC, CMO, CRO, and core project team meetings, as well as Global R&D Leadership team meetings; support Project Managers and CMC project budgets; coordinate project workshops as needed to focus on key project activities; review and provide input and direction on scientific and other regulatory documents, including meeting packages, IND