Senior CMC Quality Scientist: Investigations & Leadership

Aquestive Therapeutics, Inc.; Portage (IN); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Aquestive Therapeutics, Inc. in Portage, IN, seeks a Senior Scientist, CMC Quality to provide scientific leadership across analytical science and product performance.

The role drives investigations, informs risk‑based decisions, and partners with QA, AR&D, and Regulatory to support lifecycle decisions. The position requires leading complex investigations, interpreting stability data, and mentoring junior scientists while ensuring GMP and global regulatory expectations are met across IND/NDA

Formación

• BS in Chemistry, Pharmaceutical Sciences, or related field required.
• Minimum 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.

Responsabilidades

• 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, 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.

Conocimientos

Analytical thinking

Cross-functional collaboration

Problem solving

Scientific communication

Mentoring

Educación

BS in Chemistry or related field

Herramientas

GC

HPLC

Dissolution

Descripción del empleo

Aquestive Therapeutics, Inc. in Portage, IN, seeks a Senior Scientist, CMC Quality to provide scientific leadership across analytical science and product performance.

The role drives investigations, informs risk‑based decisions, and partners with QA, AR&D, and Regulatory to support lifecycle decisions. The position requires leading complex investigations, interpreting stability data, and mentoring junior scientists while ensuring GMP and global regulatory expectations are met across IND/NDA