Drug Safety Specialist
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-09-12
Listing for:
Dew Software
Part Time
position Listed on 2026-09-12
Job specializations:
-
Healthcare
-
Engineering
Job Description & How to Apply Below
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 SummaryClient 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.
- 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
.
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