Drug Safety Specialist

Job Title: Bio/Sterile Drug Product Process Expert Location: Boston, MA – Pier 4 Work Arrangement: Hybrid, onsite 2–3 days/week preferred for local candidates; remote candidates accepted in EST and surrounding states Duration: 1 year, with possible extension up to 2 years Start: ASAP / TBD Role Summary Client is seeking a Bio/Sterile Drug Product Process Expert / SME to provide technical oversight of sterile drug product manufacturing activities at external Contract Manufacturing Organizations (CMOs) . The SME will support technical investigations, process improvements, change implementation, process monitoring, risk assessments, regulatory/CMC activities, and cross-functional collaboration. Key Responsibilities Provide day-to-day technical oversight of sterile drug product manufacturing at external CMOs. Drive technical deviation investigations, CAPA/change implementation, and continuous improvement . Support Continuous Process Verification (CPV) and manufacturing process monitoring for commercial products. Collaborate with Quality, Operations, Supply Chain, Regulatory, and external manufacturing teams . Participate in Virtual Plant Teams and Joint Technical Teams. Serve as Servier SME/technical point of contact with CMO partners. Conduct process risk assessments and identify opportunities to mitigate process and quality risks. Author/review CMC sections of regulatory submissions . Apply structured problem-solving methodologies such as Ishikawa, Kepner-Tregoe, and 5-Why . Support aseptic processing, sterile formulation, container closure, and single-use technologies. Required Qualifications B.S. in Pharmaceutical Sciences, Chemical Engineering, or related technical field + 6+ years relevant experience; OR M.S. in Pharmaceutical Sciences, Chemical Engineering, or related field + 5+ years relevant experience. Strong experience in: Aseptic fill/finish GxP / GMP Regulatory submissions / CMC Knowledge of container closure systems and single-use technologies . Working knowledge of microbiology and extractables/leachables (E&L) . Statistical analysis experience using Minitab, JMP, or equivalent . #J-18808-Ljbffr Dew Software