Sterile Drug Product Process Expert
Dew Software
Title: Bio/Sterile Drug Product Process Expert Location priority: Boston/Pier 4, with local candidates expected onsite/hybrid 2–3 days/week. Remote is acceptable in EST/surrounding states Duration: 1 year, with possible extension up to 2 years. Education/experience: BS + 6 years or MS + 5 years in relevant pharmaceutical sciences/chemical engineering experience, specifically involving sterile drug product formulation/process development/manufacturing and regulatory submissions. Travel: Up to 20% domestic. Interview: 1–3 rounds with the HM and three team members. Critical technical expertise: Sterile formulation and aseptic fill/finish GxP and multinational regulatory requirements Container closure and single-use technologies CMO/CDMO technical oversight Deviations, change controls, CAPA/continuous improvement CPV/process monitoring Process risk assessments CMC/regulatory filing experience Problem-solving methodologies such as Ishikawa, KT, and 5-Why Microbiology and extractables/leachables #J-18808-Ljbffr Dew Software
Vacancy posted 3 days ago
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