Sterile Drug Product Process Expert — Hybrid

Eastridge Workforce Solutions; Boston (MA); Hybrid; USD 107,000 - 121,000; Full time

Job summary

Eastridge Workforce Solutions is seeking a highly experienced Bio/Sterile Drug Product Process Expert to oversee sterile drug product operations at external CMOs. The role supports aseptic manufacturing, investigations, process improvements, and regulatory filings.

The position requires a BS (6+ years) or MS (5+ years) in pharmaceutical science, with strong knowledge of GxP, regulatory submissions, and experience collaborating with CMOs/CDMOs.

Qualifications

• BS with 6+ years or MS with 5+ years of relevant pharmaceutical experience.
• Strong sterile drug product and aseptic fill/finish expertise.
• Knowledge of GxP and regulatory requirements, including regulatory submissions.
• Experience working with CMOs/CDMOs and external partners.
• Knowledge of container closure systems, microbiology, and extractables/leachables.
• Experience with root-cause analysis tools and statistical software such as Minitab or JMP.
• Strong communication, analytical, and cross-functional collaboration skills.

Responsibilities

• Provide technical oversight of sterile drug product manufacturing at external CMOs.
• Lead deviation investigations, change implementation, risk assessments, and continuous improvement.
• Support Continuous Process Verification and commercial manufacturing activities.
• Partner with Quality, Operations, Supply Chain, and external manufacturing teams.
• Author/review CMC-related content for regulatory filings.

Skills

Sterile drug expertise

GxP knowledge

CMO/CDMO experience

Root-cause analysis

Minitab/JMP

Regulatory submissions

Microbiology

Container closure

Cross-functional collaboration

Education

BS or MS in pharma

Tools

Minitab

JMP

Job description

Eastridge Workforce Solutions is seeking a highly experienced Bio/Sterile Drug Product Process Expert to oversee sterile drug product operations at external CMOs. The role supports aseptic manufacturing, investigations, process improvements, and regulatory filings.

The position requires a BS (6+ years) or MS (5+ years) in pharmaceutical science, with strong knowledge of GxP, regulatory submissions, and experience collaborating with CMOs/CDMOs.