Role Summary
The Director, Pharmaceutics will be responsible for leading Drug Product (DP) activities across a portfolio of programs at Ardelyx. Reporting to the Senior Director, Pharmaceutics, this role will partner closely with CMC, Supply Chain, Quality Assurance, Regulatory Affairs and various functions to direct activities associated with product development and/or manufacturing in alignment with business objectives. Responsibilities
Manage all Drug Product (DP) efforts, including formulation development (adult and pediatric), process development, tech transfer, and the manufacture of DP for clinical and commercial purposes Manage phase-appropriate DP project plans; develop outsourcing strategies, prepare RFPs, and manage the successful execution of plans consistent with corporate objectives and compliant with cGMP requirements Provide assistance on the preparation of the DP section of various regulatory documents (IND, NDA, etc.) Represent the DP function, and when needed the broader Tech Ops function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners Integrate DP activities with those of sister CMC functions, Supply Chain, Quality Assurance, and Regulatory Affairs Work with Supply Chain to ensure a continuous and uninterrupted supply of CTM to clinical sites and commercial materials to market Qualifications
Experience in formulation development, DP process development, tech transfer, and manufacturing Experience collaborating with technical, regulatory, quality, project management, legal, finance, and supply chain functions in a cGMP operational environment Experience in managing outsourced development, tech transfer, and manufacturing efforts as well as budgets Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs Skills
Hands-on approach; ability to set priorities, meet timelines, motivate others, and manage departmental budgets Excellent communication skills and ability to shape, frame, and present to diverse internal and external audiences Education
B.S. degree in Pharmaceutics, Pharmaceutical Sciences or Chemical Engineering; 10+ years of industry experience or equivalent Additional Requirements
Periodic travel to manufacturing and other partner sites is required (approximately 10 – 20% of time)
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The Director, Pharmaceutics will be responsible for leading Drug Product (DP) activities across a portfolio of programs at Ardelyx. Reporting to the Senior Director, Pharmaceutics, this role will partner closely with CMC, Supply Chain, Quality Assurance, Regulatory Affairs and various functions to direct activities associated with product development and/or manufacturing in alignment with business objectives. Responsibilities
Manage all Drug Product (DP) efforts, including formulation development (adult and pediatric), process development, tech transfer, and the manufacture of DP for clinical and commercial purposes Manage phase-appropriate DP project plans; develop outsourcing strategies, prepare RFPs, and manage the successful execution of plans consistent with corporate objectives and compliant with cGMP requirements Provide assistance on the preparation of the DP section of various regulatory documents (IND, NDA, etc.) Represent the DP function, and when needed the broader Tech Ops function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners Integrate DP activities with those of sister CMC functions, Supply Chain, Quality Assurance, and Regulatory Affairs Work with Supply Chain to ensure a continuous and uninterrupted supply of CTM to clinical sites and commercial materials to market Qualifications
Experience in formulation development, DP process development, tech transfer, and manufacturing Experience collaborating with technical, regulatory, quality, project management, legal, finance, and supply chain functions in a cGMP operational environment Experience in managing outsourced development, tech transfer, and manufacturing efforts as well as budgets Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs Skills
Hands-on approach; ability to set priorities, meet timelines, motivate others, and manage departmental budgets Excellent communication skills and ability to shape, frame, and present to diverse internal and external audiences Education
B.S. degree in Pharmaceutics, Pharmaceutical Sciences or Chemical Engineering; 10+ years of industry experience or equivalent Additional Requirements
Periodic travel to manufacturing and other partner sites is required (approximately 10 – 20% of time)
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