Senior Process Engineer, MS&T
$118,000–$158,000 year
On-siteCranbury, New Jersey, United States
Job Summary
Execute technology transfer, process validation, and lifecycle management for early and late-stage AAV development and commercialization. Own deviations, investigations, change controls, and process-related quality system deliverables while supporting ongoing GMP manufacturing operations and Process Improvement Program initiatives. Develop critical validation documentation for the PPQ program, including protocols, master plans, and statistical analyses. Lead root cause investigations for critical quality events and collaborate cross-functionally with Manufacturing, Quality Control, and Quality Assurance to resolve technical issues. Author and review MS&T documents, including risk assessments and Module 3 sections for IND and BLA submissions.
Required Qualifications
- PhD with 2 years, MS with 6 years, or BS with 8 years of late stage and commercial drug development experience
- Demonstrated ability to work in a self-driven, performance results/performance-oriented, fast paced environment
- Proven track-record for late-stage clinical manufacturing support and process validation execution and authoring related CTD sections
- Demonstrated ability to perform and document complex manufacturing process
- Motivated to drive and own functional initiatives and influence peers and stakeholders to collaborate and accomplish key milestones
- Experience with cGMP, ICH guidelines, process validation, and control strategy development
- Excellent verbal and written communication skills
Desired Qualifications
- Gene therapy experience is preferred
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