Jobs in Dedham, MA

About Us

We are a boutique biologics CDMO located in Newton MA . We are looking for self driven QC expert with technical expertise in biologics who will have end-to-end ownership of QC and EM investigations ensuring they are scientifically rigorous, risk-based, and inspection-ready

Key Responsibilities: 

• Own and close deviations, OOS/OOT, and EM investigations
• Lead root cause analysis and determine appropriate CAPAs
• Assess analytical, microbiological, and biological variability
• Interface directly with QA and cross-functional stakeholders
• Defend the investigation conclusion
• Drive consistency and continuous improvement in investigation practices

Qualifications: 

• BS in Chemistry, Biochemistry, or related field (MS preferred)
• 6–8 years GMP experience with ≥3 years owning investigations
• Strong background in biologics QC and microbiology/EM investigations
• Direct experience in supporting inspections
• Demonstrated ability to make independent, science-based decisions