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
...Description Job Description Are you tired of making $12 or less per hour with other security companies? We are actively hiring... ...status indicated Job Types: Full-time, Part-time Unarmed pays $15 and up, and rates for qualified and experienced armed security...
...Term) Paid time Time Off Joining our team has its perks: We encourage professional growth and development We ensure our nurses are truly happy and feel valued We offer structured preceptorships and continuing education We are committed to great patient...
...Armed Security Guard USPA Nationwide Security is a full service, licensed, bonded and insured security firm offering solutions to both... ...available to work on a varied shift pattern which could include days, nights and weekends. Current ARMED GUARD LICENSE with NY, Dept of...
...opportunity to build a stable, long-term career in the industrial chemical industry with a company that puts its employees first. Join the... ...trackmobile or locomotive to safely move railcars in the plant Communicates with rail team members, leadership, and customer...
...Company Description Job Description Position : Web Developer/Web Admin(Remote work Possibility) Duration: 6+ months Location... ...Responsive Design/Development experience. Position is part-time (contract) with little or no travel required. You should...