Director, Pharmaceutics — DP Strategy & External Partnerships

Ardelyx, Inc.; Waltham (MA); On-site; USD 211,000 - 257,000; Full time

Benefits offered by this job

401(k) plan with generous employer /

12 weeks of paid parental leave

up to 12 weeks of living organ andbone

equity incentive plans

health plans (medical, prescription, 

life insurance and disability

flexible time off

annual Winter Holiday shut down

at least 11 paid holidays

Job summary

Ardelyx, Inc. is seeking a Director of Pharmaceutics to lead Drug Product activities across a portfolio of programs in Massachusetts.

You will partner with CMC, Supply Chain, QA, Regulatory Affairs and external partners to direct product development and manufacturing aligned with business objectives. This role serves as a key cross-functional leader, driving collaboration, managing external development and manufacturing partners, identifying and mitigating risks, and supporting advancement of

Qualifications

• Bachelor's degree in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering.
• 10+ years of related experience or equivalent experience.
• Experience in DP formulation, DP process development, tech transfer, and manufacturing.
• Experience coordinating with regulatory, quality, project management, legal, finance, and supply chain teams in a cGMP environment.
• Ability to work hands-on, meet timelines, and manage departmental budgets.

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.

Skills

Excellent communication

Relationship building

Cross-functional collaboration

Budget management

Hands-on

Travel readiness

Education

B.S. in Pharmaceutics / Pharmaceutical Sciences / Chemical Engineering

Job description

Ardelyx, Inc. is seeking a Director of Pharmaceutics to lead Drug Product activities across a portfolio of programs in Massachusetts.

You will partner with CMC, Supply Chain, QA, Regulatory Affairs and external partners to direct product development and manufacturing aligned with business objectives. This role serves as a key cross-functional leader, driving collaboration, managing external development and manufacturing partners, identifying and mitigating risks, and supporting advancement of