Executive Director, Analytical Development & Quality Control
Ardelyx, Inc.
5 hours ago
Remote friendly (Waltham, MA)
United States
Operations
Position Summary:
Executive Director, Analytical Development & Quality Control (AD/QC) oversees Ardelyx’s analytical chemistry activities, including contract testing laboratories, and builds a modern, inspection-ready AD/QC capability.
Responsibilities:
- Provide strategic AD/QC roadmap aligned to company objectives and regulatory requirements
- Partner with Supply Chain, CMC, Quality Assurance, and Regulatory Affairs to develop control strategies across development and manufacturing stages
- Lead quality and process improvement initiatives
- Oversee development, validation, implementation, and lifecycle management of analytical methods for raw materials, intermediates, drug substance, and drug product
- Ensure AD/QC activities are conducted in stage-appropriate accordance with cGMPs and relevant regulatory requirements
- Author/review IND/NDA Module 3 sections (Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, Stability)
- Manage and develop AD/QC team; mentor and foster excellence and collaboration
- Develop/manage relationships with outsourced analytical testing partners
- Allocate internal/external resources to meet timelines and objectives
- Develop/monitor AD/QC KPIs
- Collaborate with QA on management reports for quality metrics and compliance status
Qualifications:
- MS or Ph.D. in Chemistry or related field
- 12+ years pharmaceutical industry experience in AD/QC; 10+ years managerial experience (or equivalent)
- Proven collaboration with Supply Chain, CMC, QA, and Regulatory Affairs
- In-depth knowledge of cGMP/ICH/FDA and analytical development & QC regulatory requirements
- Lead author experience for Module 3 sections and support of regulatory inspections
- Experience with computerized systems (e.g., LIMS, Veeva) and compliance requirements
- Strong problem-solving/decision-making and stakeholder interface skills
Benefits:
- Base pay range: $267,000–$327,000; bonus target and equity awards may be available
- 401(k) with generous match, 12 weeks paid parental leave, up to 12 weeks living organ/bone marrow leave, health plans, life insurance & disability, flexible time off, Winter Holiday shutdown, at least 11 paid holidays
Work Environment:
- Based in Waltham, MA or Newark, CA; travel up to 20%
Executive Director, Analytical Development & Quality Control (AD/QC) oversees Ardelyx’s analytical chemistry activities, including contract testing laboratories, and builds a modern, inspection-ready AD/QC capability.
Responsibilities:
- Provide strategic AD/QC roadmap aligned to company objectives and regulatory requirements
- Partner with Supply Chain, CMC, Quality Assurance, and Regulatory Affairs to develop control strategies across development and manufacturing stages
- Lead quality and process improvement initiatives
- Oversee development, validation, implementation, and lifecycle management of analytical methods for raw materials, intermediates, drug substance, and drug product
- Ensure AD/QC activities are conducted in stage-appropriate accordance with cGMPs and relevant regulatory requirements
- Author/review IND/NDA Module 3 sections (Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, Stability)
- Manage and develop AD/QC team; mentor and foster excellence and collaboration
- Develop/manage relationships with outsourced analytical testing partners
- Allocate internal/external resources to meet timelines and objectives
- Develop/monitor AD/QC KPIs
- Collaborate with QA on management reports for quality metrics and compliance status
Qualifications:
- MS or Ph.D. in Chemistry or related field
- 12+ years pharmaceutical industry experience in AD/QC; 10+ years managerial experience (or equivalent)
- Proven collaboration with Supply Chain, CMC, QA, and Regulatory Affairs
- In-depth knowledge of cGMP/ICH/FDA and analytical development & QC regulatory requirements
- Lead author experience for Module 3 sections and support of regulatory inspections
- Experience with computerized systems (e.g., LIMS, Veeva) and compliance requirements
- Strong problem-solving/decision-making and stakeholder interface skills
Benefits:
- Base pay range: $267,000–$327,000; bonus target and equity awards may be available
- 401(k) with generous match, 12 weeks paid parental leave, up to 12 weeks living organ/bone marrow leave, health plans, life insurance & disability, flexible time off, Winter Holiday shutdown, at least 11 paid holidays
Work Environment:
- Based in Waltham, MA or Newark, CA; travel up to 20%