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 .
Drug Safety Specialist in boston at Unknown Company
This position is listed as contract and able to be worked remotely.