Senior Scientist, Quality CMC
Aquestive Therapeutics
June 30, 2026
Remote friendly (Portage, IN)
United States
Operations
Job Summary:
The Senior Scientist, CMC Quality, bridges analytical science and product performance by leading scientific investigations to distinguish analytical artifacts from true product, process, or manufacturing risks.
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; determine whether observations are analytical, sampling, product, or manufacturing-related.
- Develop/review technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
- Provide independent, evidence-based scientific recommendations for Quality decision-making and governance.
- Assess method capability vs. product behavior; escalate systemic/recurring method limitation issues for lifecycle management.
- Lead/support analytical and CMC quality improvement projects as assigned.
- Assess stability trends and OOT results for potential product quality impact.
- Partner with Quality/AR&D/Regulatory to support 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.
Qualifications:
- BS in Chemistry, Pharmaceutical Sciences, or related field (required).
- Minimum 8 years in pharmaceutical/biotech QC, Chemistry, CMC/Manufacturing Controls, or Analytical Sciences.
- Proven ownership of complex OOS/OOT/deviation investigations (strategy, root cause, conclusions, CAPAs).
- Cross-functional investigation experience (QC, Manufacturing, QA, AR&D); strong analytical data interpretation tied to product quality/process performance.
- Stability program, trend analysis, product performance evaluation experience.
- Strong understanding of CMC development/commercialization, GMP and global regulatory expectations (FDA/EMA/ICH), and OOS/OOT investigation best practices.
- Experience with GC, HPLC, and Dissolution (preferred/experienced).
- Demonstrated ability to influence without authority and defend scientific positions.
- Regulatory submission support, inspections, or audits experience (preferred).
- Some travel required.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment.
The Senior Scientist, CMC Quality, bridges analytical science and product performance by leading scientific investigations to distinguish analytical artifacts from true product, process, or manufacturing risks.
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; determine whether observations are analytical, sampling, product, or manufacturing-related.
- Develop/review technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
- Provide independent, evidence-based scientific recommendations for Quality decision-making and governance.
- Assess method capability vs. product behavior; escalate systemic/recurring method limitation issues for lifecycle management.
- Lead/support analytical and CMC quality improvement projects as assigned.
- Assess stability trends and OOT results for potential product quality impact.
- Partner with Quality/AR&D/Regulatory to support 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.
Qualifications:
- BS in Chemistry, Pharmaceutical Sciences, or related field (required).
- Minimum 8 years in pharmaceutical/biotech QC, Chemistry, CMC/Manufacturing Controls, or Analytical Sciences.
- Proven ownership of complex OOS/OOT/deviation investigations (strategy, root cause, conclusions, CAPAs).
- Cross-functional investigation experience (QC, Manufacturing, QA, AR&D); strong analytical data interpretation tied to product quality/process performance.
- Stability program, trend analysis, product performance evaluation experience.
- Strong understanding of CMC development/commercialization, GMP and global regulatory expectations (FDA/EMA/ICH), and OOS/OOT investigation best practices.
- Experience with GC, HPLC, and Dissolution (preferred/experienced).
- Demonstrated ability to influence without authority and defend scientific positions.
- Regulatory submission support, inspections, or audits experience (preferred).
- Some travel required.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment.