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, manufacturing deviations.
- Support PQR/APQR product quality narratives, stability trend interpretation.
- Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations, determining whether observations arise from analytical, sampling, product, or manufacturing-related factors.
- Lead the development and 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, specifications may not reflect true capability, escalating systemic or recurring issues (i.e., lifecycle management).
- Lead or support analytical and CMC quality improvement projects, as assigned.
- Provide scientific assessment of stability trends, out of trend (OOT results), and 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 grounded in product behavior or formulation/process knowledge.
- Drive root cause analysis and scientifically sound CAPAs.
- Mentor junior scientists and provide technical guidance during investigations and problem-solving activities.
Qualifications:- BS in Chemistry, Pharmaceutical Sciences, or related field required.
- Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls (CMC), or Analytical Sciences
- Demonstrated ownership of complex OOS, OOT, and deviation investigations, including: developing investigation strategies, performing root cause analysis, defending conclusions and CAPAs
- Significant experience in: Cross-functional investigations involving QC, Manufacturing, QA, and AR&D
- Significant experience in interpreting analytical data in the context of product quality and 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 and commercialization, GMP and global regulatory expectations (FDA, EMA, ICH), OOS/OOT investigation frameworks and industry best practices
- Demonstrated ability to: influence cross-functional teams without authority, articulate and defend scientific positions in QA and leadership forums
- Strong business and product acumen, with understanding of: impact of quality decisions on supply, regulatory risk, and product lifecycle
- Experience supporting regulatory submissions (IND/NDA/MAA), inspections, or audits preferred
- Experience with instrumental techniques such as GC, HPLC, Dissolution.
- Some travel required
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
