Senior Scientist, Quality CMC
Aquestive Therapeutics
August 29, 2026
Remote friendly (Portage, IN)
United States
Operations
Job Summary:
The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.
Responsibilities:
- Serve as QC’s primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, and manufacturing deviations.
- Support PQR/APQR product quality narratives and stability trend interpretation.
- Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations to determine analytical, sampling, product, or manufacturing-related factors.
- Lead development/review of technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
- Provide independent, evidence-based scientific recommendations to support Quality decision-making and governance.
- Understand method capability vs. product behavior; identify when method limitations drive variability and specs may not reflect true capability.
- Lead/support analytical and CMC quality improvement projects.
- Provide scientific assessment of stability trends, OOT results, and potential product quality impact.
- Partner with Quality, AR&D, and Regulatory for IND/NDA/MAA submissions, post-approval commitments, and annual updates.
- Develop hypothesis-driven investigation strategies; drive root cause analysis and scientifically sound CAPAs.
- Mentor junior scientists and provide technical guidance.
Qualifications:
- BS in Chemistry, Pharmaceutical Sciences, or related field (required).
- Minimum 8 years in pharmaceutical/biotech Quality Control, Chemistry, CMC, or Analytical Sciences.
- Demonstrated ownership of complex OOS/OOT/deviation investigations (strategy, root cause, defending conclusions/CAPAs).
- Significant cross-functional investigation experience (QC, Manufacturing, QA, AR&D).
- Significant experience interpreting analytical data for product quality/process performance.
- Significant experience in stability programs, trend analysis, and product performance evaluation.
- Significant experience in analytical method capability, variability, and limitations.
- Strong understanding of CMC development/commercialization, GMP, global regulatory expectations (FDA, EMA, ICH), and OOS/OOT frameworks.
- Ability to influence cross-functional teams without authority; articulate/defend scientific positions.
- Strong business/product acumen regarding quality decisions, supply, regulatory risk, and lifecycle.
- Regulatory submissions/inspections/audits experience (preferred).
- Experience with GC, HPLC, Dissolution (instrumental techniques).
- Some travel required.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment commencing.
The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.
Responsibilities:
- Serve as QC’s primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, and manufacturing deviations.
- Support PQR/APQR product quality narratives and stability trend interpretation.
- Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations to determine analytical, sampling, product, or manufacturing-related factors.
- Lead development/review of technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
- Provide independent, evidence-based scientific recommendations to support Quality decision-making and governance.
- Understand method capability vs. product behavior; identify when method limitations drive variability and specs may not reflect true capability.
- Lead/support analytical and CMC quality improvement projects.
- Provide scientific assessment of stability trends, OOT results, and potential product quality impact.
- Partner with Quality, AR&D, and Regulatory for IND/NDA/MAA submissions, post-approval commitments, and annual updates.
- Develop hypothesis-driven investigation strategies; drive root cause analysis and scientifically sound CAPAs.
- Mentor junior scientists and provide technical guidance.
Qualifications:
- BS in Chemistry, Pharmaceutical Sciences, or related field (required).
- Minimum 8 years in pharmaceutical/biotech Quality Control, Chemistry, CMC, or Analytical Sciences.
- Demonstrated ownership of complex OOS/OOT/deviation investigations (strategy, root cause, defending conclusions/CAPAs).
- Significant cross-functional investigation experience (QC, Manufacturing, QA, AR&D).
- Significant experience interpreting analytical data for product quality/process performance.
- Significant experience in stability programs, trend analysis, and product performance evaluation.
- Significant experience in analytical method capability, variability, and limitations.
- Strong understanding of CMC development/commercialization, GMP, global regulatory expectations (FDA, EMA, ICH), and OOS/OOT frameworks.
- Ability to influence cross-functional teams without authority; articulate/defend scientific positions.
- Strong business/product acumen regarding quality decisions, supply, regulatory risk, and lifecycle.
- Regulatory submissions/inspections/audits experience (preferred).
- Experience with GC, HPLC, Dissolution (instrumental techniques).
- Some travel required.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment commencing.