Senior Scientist, Quality CMC
On-sitePortage, Indiana, United States
Job Summary
Senior Scientist, CMC Quality provides scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks; leads complex investigations (OOS, OOT, deviations) and risk assessments; develops and reviews technically complex investigations and regulatory support documentation; partners with Quality, AR&D, and Regulatory to support IND/NDA/MAA submissions and post-approval updates; mentors junior scientists; drives cross-functional collaboration to ensure sound, risk-based decisions across the product lifecycle; assesses stability trends and potential impacts to product quality; ensures method capability alignment with product behavior and escalates systemic issues; supports quality improvement projects and problem-solving activities; requires a BS in Chemistry or related field and significant experience in pharmaceutical/biotech QC/CMC/analytical sciences with proficiency in GC, HPLC, and Dissolution.
Required 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.