CMC Quality Scientist: Investigations & Risk Leader

Aquestive Therapeutics

Portage (IN)

On-site

USD 120,000 - 180,000

Full time

3 days ago

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Job summary

Aquestive Therapeutics is seeking a Senior Scientist, CMC Quality to bridge analytical science and product performance, providing scientific leadership for complex investigations and risk-based decisions across the product lifecycle. You will lead investigations of OOS/OOT, oversee risk assessments, support IND/NDA/MAA submissions, and mentor scientists while collaborating with QC, AR&D, and Regulatory.

A BS in Chemistry or related field and 8+ years of pharma/biotech QA/CMC experience are

Qualifications

BS in Chemistry, Pharmaceutical Sciences, or related field required.
8+ years in pharmaceutical/biotech Quality Control, CMC, or Analytical Sciences.
Experience owning complex OOS/OOT investigations and CAPAs.
Strong cross-functional investigation experience with QC, Manufacturing, QA, and AR&D.
Experience interpreting analytical data in product quality and process performance.
Experience with regulatory submissions (IND/NDA/MAA) preferred.

Responsibilities

Lead and oversee complex OOS, OOT, deviation investigations and risk assessments.
Provide scientific recommendations to support QA decisions and governance.
Mentor junior scientists and guide investigations and problem-solving.
Partner with QC, AR&D, Regulatory to support IND/NDA/MAA submissions.
Develop investigation strategies and CPSAs with data-driven rationale.