Sterile Drug Product Process Expert — CMO Oversight

Real; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement savings plans

Life insurance

Disability insurance

Paid leave

Job summary

Real is seeking a Bio/Sterile Drug Product Process Expert to provide technical oversight of sterile drug product manufacturing at external CMOs. The role partners with Quality, Operations, and Regulatory to drive investigations, changes, and process improvements for commercial sterile products.

The candidate will review CMC sections for regulatory filings, perform risk assessments, and lead cross-functional teams to ensure robust Process Verification and compliant manufacturing amidst a 12-month

Qualifications

• BS in Pharmaceutical Sciences or Chemical Engineering with 6+ years in sterile drug product formulation and manufacturing, or MS with 5+ years.
• Deep knowledge of sterile drug product formulation and aseptic fill/finish processes and GxPs/regulatory guidelines.
• Experience with regulatory submissions and CMC sections.

Responsibilities

• Oversee day-to-day activities at external CMOs for sterile drug product manufacturing.
• Drive investigations, deviations, and continuous improvements.
• Collaborate with Quality, Operations, Supply Chain, and Manufacturing teams.

Skills

Sterile drug product formulation

Aseptic fill/finish

GxPs & regulatory guidelines

Process risk assessments

Problem-solving tools (Ishikawa, KT, 5

Statistical methods (Minitab, JMP)

Cross-functional collaboration

External manufacturing partnerships

Education

BS in PharmSci or ChemEng

MS in PharmSci or ChemEng

Tools

Minitab

JMP

Job description

Real is seeking a Bio/Sterile Drug Product Process Expert to provide technical oversight of sterile drug product manufacturing at external CMOs. The role partners with Quality, Operations, and Regulatory to drive investigations, changes, and process improvements for commercial sterile products.

The candidate will review CMC sections for regulatory filings, perform risk assessments, and lead cross-functional teams to ensure robust Process Verification and compliant manufacturing amidst a 12-month