Director of Analytical Development — Lead cGMP Strategy

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

Benefits offered by this job

401(k) plan with employer match

Equity awards

Paid parental leave

Health plans (medical, prescription, 


Job summary

Ardelyx, Inc. is seeking a Director of Analytical Development to lead analytical strategies for commercial drug substance and product, partnering with CMC, Quality, Regulatory Affairs, and external partners to ensure compliant, reliable supply.

The role emphasizes cross-functional leadership, experience in analytical chemistry, and managing outsourced activities and budgets, with travel up to 10-20% and a competitive compensation package.

Qualifications

• Bachelor’s degree in chemistry or related discipline; 10+ years of industry experience.
• Strong experience in analytical chemistry and regulatory requirements.
• Experience leading outsourced analytical activities and managing budgets.

Responsibilities

• Develop and lead execution of analytical strategies and manage partner projects.
• Establish resource plans and budgets to meet objectives.
• Integrate Commercial Analytical with other CMC functions.
• Prepare analytical content for regulatory documents.
• Represent Commercial Analytical on cross-functional and external teams.
• Advise senior leadership on analytical risks and lifecycle strategies.

Skills

Analytical chemistry

Regulatory requirements

Cross-functional collaboration

Regulatory document preparation

Education

Bachelor’s degree in chemistry

Advanced degree preferred

Job description

Ardelyx, Inc. is seeking a Director of Analytical Development to lead analytical strategies for commercial drug substance and product, partnering with CMC, Quality, Regulatory Affairs, and external partners to ensure compliant, reliable supply.

The role emphasizes cross-functional leadership, experience in analytical chemistry, and managing outsourced activities and budgets, with travel up to 10-20% and a competitive compensation package.