Director, Drug Product Development & Tech Transfer

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

Benefits offered by this job

401(k) plan with match

Parental leave

Equity incentive plans

Health plans

Holiday time off

Job summary

Ardelyx is seeking a Director of Pharmaceutics to lead Drug Product activities across multiple programs, partnering with CMC, Supply Chain, QA and Regulatory Affairs to align product development with business goals.

The role drives external partnership management, risk mitigation, and DP development to advance Ardelyx's portfolio, with travel to manufacturing sites as needed and accountability for project budgets and timelines.

Qualifications

• BS degree in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering with 10+ years of related experience or equivalent
• 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 environment
• Experience managing outsourced development, tech transfer, and manufacturing and budgets
• Experience preparing/regulatory documents including briefing books for INDs & NDAs
• Hands-on ability to prioritize, meet timelines, and manage budgets
• Excellent communication and the ability to present to diverse audiences
• Proven ability to build relationships with internal/external stakeholders and influence decisions
• Periodic travel to manufacturing/partner sites (10-20%)

Responsibilities

• Manage DP efforts including formulation development, process development, tech transfer, and DP manufacturing for clinical and commercial use
• Develop phase-appropriate DP project plans, outsourcing strategies, RFPs, and manage execution with cGMP compliance
• Provide technical leadership for DP sections of regulatory documents (IND, NDA) ensuring accuracy and compliance
• Represent DP and Tech Ops on cross-functional teams with internal and external partners
• Integrate DP activities with sister CMC functions, Supply Chain, QA, and Regulatory Affairs across product lifecycle
• Coordinate with Supply Chain to ensure uninterrupted CTM supply to clinical sites and market

Skills

Formulation development

Tech transfer

Outsourced development

Regulatory documents

Cross-functional collaboration

Budget management

Communication skills

Stakeholder management

Travel availability

Education

Bachelor’s in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering

Job description

Ardelyx is seeking a Director of Pharmaceutics to lead Drug Product activities across multiple programs, partnering with CMC, Supply Chain, QA and Regulatory Affairs to align product development with business goals.

The role drives external partnership management, risk mitigation, and DP development to advance Ardelyx's portfolio, with travel to manufacturing sites as needed and accountability for project budgets and timelines.