Sterile Drug Process SME & CMO Technical Lead

Dew Software; Boston (MA); Hybrid; USD 125,000 - 165,000; Full time

Job summary

Servier seeks a Bio/Sterile Drug Product Process Expert to provide technical oversight of sterile drug product manufacturing at external CMOs. You will lead investigations, CAPA/change implementation, and continuous improvement efforts while supporting CPV and process monitoring for commercial products.

You will collaborate with Quality, Operations, Regulatory, and Supply Chain teams, participate in cross-functional teams, and act as the technical point of contact with CMOs.

Qualifications

• B.S. in Pharmaceutical Sciences, Chemical Engineering, or related technical field + 6+ years of experience OR
• M.S. in Pharmaceutical Sciences, Chemical Engineering, or related field + 5+ years of experience

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 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 risks.
• Author/review CMC sections of regulatory submissions.
• Apply Ishikawa, Kepner-Tregoe, and 5-Why problem-solving methods.
• Support aseptic processing, sterile formulation, container closure, and single-use technologies.

Skills

Aseptic fill/finish

GxP / GMP

CMC submissions

Container closure systems

Single-use technologies

Microbiology knowledge

E&L (extractables/leachables)

Statistical analysis (Minitab/JMP)

Education

B.S. in Pharmaceutical Sciences / Chemical Engineering or related field

M.S. in Pharmaceutical Sciences / Chemical Engineering or related field

Tools

Minitab

JMP

Job description

Servier seeks a Bio/Sterile Drug Product Process Expert to provide technical oversight of sterile drug product manufacturing at external CMOs. You will lead investigations, CAPA/change implementation, and continuous improvement efforts while supporting CPV and process monitoring for commercial products.

You will collaborate with Quality, Operations, Regulatory, and Supply Chain teams, participate in cross-functional teams, and act as the technical point of contact with CMOs.