DescriptionPosition Summary:The Director, Pharmaceutics is responsible for leading the planning and execution of Drug Product (DP) activities across a portfolio of programs at Ardelyx. Reporting to the Senior Director, Pharmaceutics, this role partners closely with CMC, Supply Chain, Quality Assurance, Regulatory Affairs and various cross-functional internal and external partners to direct activities associated with product development and/or manufacturing in alignment with business objectives.
This role serves as a key cross-functional leader, driving collaboration, managing external development and manufacturing partners, identifying and mitigating technical and supply risks, and supporting the successful advancement of Ardelyx's product portfolio.
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 and technical leadership on the preparation of the DP section of various regulatory documents (IND, NDA, etc.), ensuring scientific accuracy and regulatory compliance
- 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, ensuring effective cross-functional communication and execution throughout the product lifecycle
- Work with Supply Chain to ensure a continuous and uninterrupted supply of CTM to clinical sites and commercial materials to market
- Drive continuous improvement initiatives that enhance product quality, manufacturing efficiency, operational excellence, and overall Drug Product development capabilities
Qualifications:- B.S. degree in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering, with 10+ years of related 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
- Ability to work in a "hands on" environment while setting priorities, meeting stringent timelines, and managing departmental budgets effectively and efficiently
- Excellent communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite
- Proven ability to build strong relationships with internal stakeholders and external partners while effectively influencing decisions across multiple functional areas
- Periodic travel to manufacturing and other partner sites is required (approximately 10 - 20% of time)
The anticipated annualized base pay range for this full-time position is $211,000-$257,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
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.
