Sterile Drug Product Process Expert

Dew Software; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Dew Software seeks a Bio/Sterile Drug Product Process Expert in Boston/Pier 4, with onsite/hybrid 2–3 days per week. Location may be remote within EST and surrounding states. The role is 1 year, with potential extension to 2 years.

Requires BS + 6 years or MS + 5 years in sterile drug product formulation, process development, manufacturing, and regulatory submissions. Candidate must travel up to 20% domestically and endure 1–3 interviews with hiring manager and team members.

Qualifications

• BS + 6 years or MS + 5 years in relevant pharmaceutical sciences/chemical engineering experience
• Sterile drug product formulation/process development/manufacturing
• Regulatory submissions experience (CMC) and regulatory filings

Skills

Sterile Fill/Finish

GxP Compliance

Container Closure

Single-Use Technologies

CMO/CDMO Oversight

Deviations & CAPA

CPV/Process Monitoring

Process Risk Assessments

CMC Regulatory Filing

Problem-Solving (Ishikawa/5-Why)

Microbiology & Extractables/Leachables

Education

BS + 6 years experience

MS + 5 years experience

Job description

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