Scientist , Quality Control; 2nd Shift

The Position:
Scientist I, Quality Control (2nd shift; eligible for a 10% shift differential).

Support analytical method validation, method transfer, and quality control testing for pharmaceutical raw materials, in-process manufacturing samples, drug substance, drug product, and stability studies.

• Perform analytical testing of raw materials, in-process samples, drug substances, drug products, and stability samples using validated methods.
• Execute method validation, method transfer, and routine QC testing per cGMP and ICH guidelines.
• Operate, troubleshoot, and interpret data from analytical instrumentation (LC-MS; HPLC/UHPLC—RP and AEX; GC; Karl Fischer titration; FTIR; Endotoxin/LAL; Raman spectroscopy).
• Analyze/interpret data, including stability trends and degradation profiles.
• Independently investigate analytical results; make sound scientific decisions ensuring data quality and compliance.
• Collaborate cross-functionally with Analytical Development, Manufacturing, and Quality.
• Lead technical discussions, troubleshoot analytical challenges, and contribute to continuous improvement.
• Train/mentor colleagues; maintain cGMP/GDP-compliant documentation.
• Support lab investigations, method improvements, and other QC initiatives.

• BS in Chemistry (or related) with 5+ years lab experience, or MS with 3+ years.
• cGMP and ICH laboratory requirements/operations knowledge.
• Strong documentation and attention to detail; able to work within hold times/turnaround targets.
• Experience testing oligonucleotides, peptides, or synthetic biomolecules.
• Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, or LAL/endotoxin testing.
• Experience supporting in-process (real-time) testing in a manufacturing-adjacent QC lab.
• Proficient in analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and cGMP policies/practices.

Pay range: $90,000 USD - $108,000 USD.