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To support commercialization of our late-stage drug candidate, the CMC team is seeking an experienced manufacturing leader with deep small molecule expertise to provide strategic planning and operational oversight across our bulk product supply chain. Work hands-on to seamlessly manage manufacturing operations at external suppliers, including contracting, scheduling of production to meet forecast demand, change control and deviation management, and issue escalation.

Overview   Priovant is committed to developing therapies that address high unmet need in autoimmune disease. To support commercialization of our late-stage drug candidate, the CMC team is seeking an experienced manufacturing leader with deep small molecule expertise to provide strategic planning and operational oversight across our bulk product supply chain. The successful candidate will work directly with our external manufacturing partners, ensuring seamless product flow and robust commercial supply. The Senior Director, Commercial Manufacturing reports to the Senior Vice President, CMC. The position is remote, with domestic and international travel required as necessary to oversee activities at manufacturing partners, and to meet with the team periodically at our Durham, NC office.  Responsibilities  <ul><li>Strategically build and manage the commercial supply chain for small molecule pharmaceutical products, including starting materials, drug substance, and bulk drug product. </li><li>Work hands-on to seamlessly manage manufacturing operations at external suppliers, including contracting, scheduling of production to meet forecast demand, change control and deviation management, and issue escalation. </li><li>Lead product pricing negotiations, establish supply agreements, collaborate with legal to maintain relevant contracts, and manage the budget for bulk product manufacturing. </li><li>Partner with drug substance and drug product technical leads to expand production to additional sites as required to meet demand and globally minimize supply chain risk. </li><li>Collaborate with Regulatory to assure compliance of manufacturing activities with global regulatory requirements and filed product information. </li><li>Partner with Quality to author and implement relevant policies and operating procedures, maintain quality agreements, monitor for gaps, and establish appropriate mitigation strategies to ensure global product quality. </li></ul> Qualifications  <ul><li>BS or BA in chemistry, chemical engineering, or related scientific discipline, with at least 12 years of small molecule manufacturing experience. </li><li>Top-tier expertise in managing external production networks for bulk pharmaceutical products, with a proven track record of working successfully with commercial manufacturing partners.  </li><li>Detailed understanding of drug substance manufacturing, including the ability to review executed batch records, understand the impact of analytical test results, and manage deviations. </li><li>Ability to participate in complex commercial supply negotiations, critically review service agreements, and assure quality agreements align with operational goals.  </li><li>Current knowledge of relevant global regulatory requirements that could impact production, testing, release, or distribution of products. </li></ul>

Priovant Therapeutics

Senior Director, Commercial Manufacturing

Analysis Skills

Autoimmune Disease

Biotech and Pharmaceutical

Budget Management

Change Control

Chemical Engineering

Chemistry

Contract Management

Demand Forecasting/Planning

Drug Manufacturing

Drug Products

Legal

Manufacturing

Manufacturing Operations Management

Negotiation Skills

Network Administration/Management

Operational Strategy

Operations Planning

Operations Processes

Policy Implementation

Product Flow

Product Pricing

Production Schedule

Quality Management

Quality Monitoring

Regulatory Compliance

Regulatory Requirements

Risk Management

Small Molecules

Strategic Planning

Supply Chain

Supply Chain Management

Technical Leadership

Willing to Travel

Writing Skills

GreenHouseAPI

Hybrid Production Jobs in Durham, NC

Hybrid Production Jobs in Durham, NC

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Senior Director, Commercial Manufacturing Priovant Therapeutics

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