Director, Pharmaceutics

Ardelyx • Waltham, MA

17d • $210,000 - $256,000

About The Position

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position 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.

Requirements

• B.S. degree in Pharmaceutics, Pharmaceutical Sciences or Chemical Engineering with 10+ years of industry experience or equivalent experience
• Experience in the areas of formulation development, DP process development, tech transfer, and manufacturing
• Experience working in close collaboration 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 associated operating budgets
• Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
• Desire to work “hands on”, setting priorities, meeting timelines, motivating others, and managing departmental budgets
• Excellent communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite
• Periodic travel to manufacturing and other partner sites is required (approximately 10 – 20% of time)

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

Benefits

• Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees