Senior Scientist, Quality CMC

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.

• Serve as QCs 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.

As part of Aquestives 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.

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.

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 candidates relevant skills experience and education.

Required Experience:

Senior IC