Senior Scientist, Quality CMC
Aquestive Therapeutics
September 02, 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.
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 scientific oversight for complex OOS, OOT, deviation, and product quality investigations to determine analytical, sampling, product, or manufacturing-related causes.
- 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 escalate systemic/recurring issues.
- Lead or support analytical and CMC quality improvement projects (as assigned).
- Assess stability trends and OOT results and their potential impact to product quality.
- Partner with Quality, AR&D, and 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 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.
- Ownership of complex OOS/OOT/deviation investigations; strategy development, root cause analysis, and defending conclusions/CAPAs.
- Cross-functional investigation experience (QC, Manufacturing, QA, AR&D).
- Experience interpreting analytical data in context of product quality and process performance.
- Stability program, trend analysis, and product performance evaluation experience.
- Analytical method capability/variability/limitations experience.
- Strong understanding of CMC development/commercialization, GMP, global regulatory expectations (FDA/EMA/ICH), and OOS/OOT investigation frameworks.
- Ability to influence teams without authority and defend scientific positions.
- Business/product acumen regarding quality decision impact on supply, regulatory risk, and lifecycle.
- Regulatory submissions/inspections/audits experience (preferred).
- Instrumental techniques: GC, HPLC, Dissolution (experience).
- Some travel required.
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.
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 scientific oversight for complex OOS, OOT, deviation, and product quality investigations to determine analytical, sampling, product, or manufacturing-related causes.
- 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 escalate systemic/recurring issues.
- Lead or support analytical and CMC quality improvement projects (as assigned).
- Assess stability trends and OOT results and their potential impact to product quality.
- Partner with Quality, AR&D, and 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 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.
- Ownership of complex OOS/OOT/deviation investigations; strategy development, root cause analysis, and defending conclusions/CAPAs.
- Cross-functional investigation experience (QC, Manufacturing, QA, AR&D).
- Experience interpreting analytical data in context of product quality and process performance.
- Stability program, trend analysis, and product performance evaluation experience.
- Analytical method capability/variability/limitations experience.
- Strong understanding of CMC development/commercialization, GMP, global regulatory expectations (FDA/EMA/ICH), and OOS/OOT investigation frameworks.
- Ability to influence teams without authority and defend scientific positions.
- Business/product acumen regarding quality decision impact on supply, regulatory risk, and lifecycle.
- Regulatory submissions/inspections/audits experience (preferred).
- Instrumental techniques: GC, HPLC, Dissolution (experience).
- Some travel required.