Description

<span data-ccp-parastyle="Default" data-ccp-parastyle-defn="{&quot;ObjectId&quot;:&quot;272499da-5523-5969-b17c-4f82c0ce3910|1&quot;,&quot;ClassId&quot;:1073872969,&quot;Properties&quot;:[469775450,&quot;Default&quot;,201340122,&quot;2&quot;,134233614,&quot;true&quot;,469778129,&quot;Default&quot;,335572020,&quot;1&quot;,469777841,&quot;Times New Roman&quot;,469777842,&quot;Times New Roman&quot;,469777844,&quot;Times New Roman&quot;,469769226,&quot;Times New Roman&quot;,335551500,&quot;0&quot;,335559740,&quot;240&quot;,201341983,&quot;0&quot;,335559739,&quot;0&quot;,201342446,&quot;1&quot;,201342447,&quot;5&quot;,201342448,&quot;1&quot;,201342449,&quot;1&quot;,469777843,&quot;Aptos&quot;,201341986,&quot;1&quot;,268442635,&quot;24&quot;]}">Overview  &nbsp; 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.&nbsp; <span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{&quot;ObjectId&quot;:&quot;ac0262f4-8a9e-5820-b908-2d943c5f7113|1&quot;,&quot;ClassId&quot;:1073872969,&quot;Properties&quot;:[201342446,&quot;1&quot;,201342447,&quot;5&quot;,201342448,&quot;1&quot;,201342449,&quot;1&quot;,469777841,&quot;Calibri&quot;,469777842,&quot;&quot;,469777843,&quot;Calibri&quot;,469777844,&quot;Calibri&quot;,201341986,&quot;1&quot;,469769226,&quot;Calibri&quot;,268442635,&quot;22&quot;,469775450,&quot;normaltextrun&quot;,201340122,&quot;1&quot;,134233614,&quot;true&quot;,469778129,&quot;normaltextrun&quot;,335572020,&quot;1&quot;,469778324,&quot;Default Paragraph Font&quot;]}">The&nbsp;Senior Director, Commercial Manufacturing&nbsp;reports to the Senior Vice President, CMC. The position is remote, with domestic and international travel required as necessary to&nbsp;oversee activities at&nbsp;manufacturing partners, and to meet with the team periodically at our Durham, NC office.&nbsp; &nbsp; Responsibilities<span data-ccp-charstyle="eop" data-ccp-charstyle-defn="{&quot;ObjectId&quot;:&quot;920dbcde-2834-5e15-a5fa-062170b236ba|1&quot;,&quot;ClassId&quot;:1073872969,&quot;Properties&quot;:[201342446,&quot;1&quot;,201342447,&quot;5&quot;,201342448,&quot;1&quot;,201342449,&quot;1&quot;,469777841,&quot;Calibri&quot;,469777842,&quot;&quot;,469777843,&quot;Calibri&quot;,469777844,&quot;Calibri&quot;,201341986,&quot;1&quot;,469769226,&quot;Calibri&quot;,268442635,&quot;22&quot;,469775450,&quot;eop&quot;,201340122,&quot;1&quot;,134233614,&quot;true&quot;,469778129,&quot;eop&quot;,335572020,&quot;1&quot;,469778324,&quot;Default Paragraph Font&quot;]}"> &nbsp; <ul> <li>Strategically build and manage&nbsp;the&nbsp;commercial&nbsp;supply chain for&nbsp;small molecule pharmaceutical&nbsp;products, including starting materials,&nbsp;drug&nbsp;substance,&nbsp;and&nbsp;bulk&nbsp;drug&nbsp;product.&nbsp;</li> <li>Work hands-on&nbsp;to&nbsp;seamlessly&nbsp;manage&nbsp;manufacturing operations at external suppliers, including&nbsp;contracting,&nbsp;scheduling of production to meet forecast demand, change control and deviation management, and issue escalation.&nbsp;</li> <li>Lead product pricing negotiations,&nbsp;establish&nbsp;supply agreements, collaborate with legal to&nbsp;maintain&nbsp;relevant contracts, and manage the budget for bulk product&nbsp;manufacturing.&nbsp;</li> <li>Partner&nbsp;with&nbsp;drug substance and drug product&nbsp;technical&nbsp;leads&nbsp;to expand&nbsp;production&nbsp;to&nbsp;additional&nbsp;sites&nbsp;as&nbsp;required&nbsp;to&nbsp;meet&nbsp;demand&nbsp;and&nbsp;globally&nbsp;minimize&nbsp;supply chain risk.&nbsp;</li> <li>Collaborate&nbsp;with&nbsp;Regulatory to&nbsp;assure&nbsp;compliance&nbsp;of&nbsp;manufacturing activities&nbsp;with&nbsp;global regulatory requirements&nbsp;and filed product information.&nbsp;</li> <li>Partner with Quality&nbsp;to&nbsp;author and&nbsp;implement relevant&nbsp;policies and operating procedures,&nbsp;maintain&nbsp;quality agreements,&nbsp;monitor for&nbsp;gaps, and&nbsp;establish&nbsp;appropriate mitigation&nbsp;strategies to ensure global&nbsp;product quality.&nbsp;</li> </ul> &nbsp; Qualifications &nbsp; <ul> <li>BS or BA&nbsp;in chemistry, chemical engineering, or related&nbsp;scientific&nbsp;discipline, with at least 12&nbsp;years of&nbsp;small molecule&nbsp;manufacturing&nbsp;experience.&nbsp;</li> <li>Top-tier&nbsp;expertise&nbsp;in managing&nbsp;external&nbsp;production networks for&nbsp;bulk&nbsp;pharmaceutical products,&nbsp;with a proven&nbsp;track record&nbsp;of&nbsp;working successfully with commercial manufacturing partners.&nbsp;&nbsp;</li> <li>Detailed understanding of&nbsp;drug substance manufacturing,&nbsp;including&nbsp;the ability to&nbsp;review executed batch&nbsp;records, understand the impact of analytical&nbsp;test&nbsp;results, and manage&nbsp;deviations.&nbsp;</li> <li>Ability to&nbsp;participate&nbsp;in complex commercial supply negotiations, critically review service agreements, and&nbsp;assure&nbsp;quality agreements align with operational goals.&nbsp;&nbsp;</li> <li>Current knowledge of relevant global regulatory requirements that could&nbsp;impact&nbsp;production, testing, release, or distribution of&nbsp;products.&nbsp;</li> </ul>

Senior Director, Commercial Manufacturing

Description

Priovant Therapeutics