Associate Director, Stability
Ardelyx, Inc.
4 hours ago
Remote friendly (Waltham, MA)
United States
$169,000 - $207,000 USD yearly
Operations
Position Summary
- Associate Director, Stability working with integrated teams to design, manage, and evaluate stability studies at contractors for both drug substance and drug product; manage stability studies across early and commercial stages; apply knowledge of ICH and cGMP and contribute to regulatory filings as needed.
Responsibilities
- Develop and implement stability program strategy aligned with corporate goals and product life-cycle objectives
- Oversee the design, execution, and management of stability studies (development, registration, and commercial)
- Collaborate cross-functionally with CMC, supply chain, quality, regulatory, clinical, and related teams
- Contract with and manage manufacturing and analytical contractors; support finance forecasting and expense tracking
- Coordinate the movement of material to stability contractors from manufacturing sites as needed
- Initiate and drive stability protocol generation and other quality documents
- Compile results; conduct trend and statistical analyses; prepare reports for retest/shelf-life extensions and storage condition recommendations
- Partner with quality during stability quality events/investigations and implementation of CAPAs at contractors
- Author CMC stability documentation for IND, NDA, and IMPD filings across clinical development and commercial activities
- Represent stability function and present at intra/inter-departmental meetings
Qualifications
- B.S. in a scientific field (e.g., chemistry or biology) plus 10+ years pharmaceutical industry experience (or equivalent)
- Excellent knowledge of small molecule analytical chemistry (prior analytical scientist experience desirable)
- Flexible, adaptive team player; excellent verbal and written communication skills
- Exceptional organizational skills and attention to detail
- Extensive experience with small molecule drug product and drug substance stability programs
- Experience managing contractor stability activities
- Extensive experience with ICH and FDA guidelines
- Experience authoring regulatory submissions (IND, NDA, MAA) and associated reports
- Ability to travel up to 5%
Benefits (if applicable)
- 401(k) with generous employer match; paid parental leave; living organ and bone marrow leave; equity incentive plans; health plans; life insurance and disability; flexible time off; annual Winter Holiday shutdown; at least 11 paid holidays
Work Location
- Hybrid: Waltham, MA or Newark, CA; on-site 2–3 days per week
- Associate Director, Stability working with integrated teams to design, manage, and evaluate stability studies at contractors for both drug substance and drug product; manage stability studies across early and commercial stages; apply knowledge of ICH and cGMP and contribute to regulatory filings as needed.
Responsibilities
- Develop and implement stability program strategy aligned with corporate goals and product life-cycle objectives
- Oversee the design, execution, and management of stability studies (development, registration, and commercial)
- Collaborate cross-functionally with CMC, supply chain, quality, regulatory, clinical, and related teams
- Contract with and manage manufacturing and analytical contractors; support finance forecasting and expense tracking
- Coordinate the movement of material to stability contractors from manufacturing sites as needed
- Initiate and drive stability protocol generation and other quality documents
- Compile results; conduct trend and statistical analyses; prepare reports for retest/shelf-life extensions and storage condition recommendations
- Partner with quality during stability quality events/investigations and implementation of CAPAs at contractors
- Author CMC stability documentation for IND, NDA, and IMPD filings across clinical development and commercial activities
- Represent stability function and present at intra/inter-departmental meetings
Qualifications
- B.S. in a scientific field (e.g., chemistry or biology) plus 10+ years pharmaceutical industry experience (or equivalent)
- Excellent knowledge of small molecule analytical chemistry (prior analytical scientist experience desirable)
- Flexible, adaptive team player; excellent verbal and written communication skills
- Exceptional organizational skills and attention to detail
- Extensive experience with small molecule drug product and drug substance stability programs
- Experience managing contractor stability activities
- Extensive experience with ICH and FDA guidelines
- Experience authoring regulatory submissions (IND, NDA, MAA) and associated reports
- Ability to travel up to 5%
Benefits (if applicable)
- 401(k) with generous employer match; paid parental leave; living organ and bone marrow leave; equity incentive plans; health plans; life insurance and disability; flexible time off; annual Winter Holiday shutdown; at least 11 paid holidays
Work Location
- Hybrid: Waltham, MA or Newark, CA; on-site 2–3 days per week