New · posted Oct 15
Aquestive Therapeutics · Pharmaceuticals
Senior Scientist, Quality CMC
- Portage, IN
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
What you need
- 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
As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
What you'll do
- 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.
Where you'll work
Portage, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Portage, INEqual opportunity, accessibility and legal noticesAquestive Therapeutics's statements, word for word
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.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in Indiana8 roles publishing pay
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Indiana (middle half) | $78,375 | $78,500 | $78,500 |
| All US (middle half) | $78,500 | $95,000 | $108,500 |
Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Aquestive Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods14
- Investigations and CAPA10
- Collaboration and leadership7
- GMP and compliance2
- Regulatory submissions2
- Documentation and SOPs1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Aquestive Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality3 75%
- Regulatory1 25%
By level
- Senior & Principal2 50%
- Director1 25%
- Associate & Specialist1 25%
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Senior Scientist, Quality CMC at Aquestive Therapeutics
Open until filled.