Bio/Sterile Drug Product Process Expert Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. We are seeking a Bio/Sterile Drug Product Process Expert to support our client's team.
Job Title: Bio/Sterile Drug Product Process Expert
Location: Boston, MA – Hybrid preferred; Remote EST candidates considered
Shift:
Monday–FridayHourly Pay Range and Other Compensation: $78.00–$87.75 per hour, depending on experience and qualifications.
Employment Type:
Full-Time | Temporary Contract – 1 year with potential extensionFLSA Status: Non-Exempt
Schedule:
40 hours/week; Boston candidates expected onsite 2–3 days/week. Up to 20% travel.
Job Summary:
Eastridge Workforce Solutions is hiring an experienced Bio/Sterile Drug Product Process Expert to provide technical oversight of sterile drug products manufactured at external CMOs. This role will support aseptic manufacturing, technical investigations, process improvements, and regulatory activities.
Essential Duties and 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.
Requirements:
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.
