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Principal Engineer, Manufacturing Sciences and Technology - Burlington, United States - Sarepta Therapeutics
Description
With the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients.
This position will report to the Director of the Commercial MSAT team and will be responsible for providing technical support to late-stage and commercial gene therapy programs.
This person will be responsible for data acquisition & analysis, providing technical leadership for critical investigations, process changes, and continuous improvement projects to ensure uninterrupted product supply.
The ideal candidate should be well-versed in all CMC aspects of early clinical, late-stage, and commercial programs. Previous experience working with cross-functional teams in a GMP setting is essential for this role.Primary Responsibilities Include:
Support viral vector and plasmid manufacturing at CMOs.
Evaluate process issues using statistical tools and provide remediation to ensure product safety and quality.
Technical SME for setting up systems for data acquisition from GMP sources.
Perform data analysis and generate process insights.
Establish process monitoring programs, evaluate process health, and provide updates to key stakeholders.
Support continued process verification program and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
Lead technical discussions to support critical deviations, change controls, and CAPAs.
Review and approve quality documents from CMOs including but not limited to deviation reports, change controls, and CAPAs.
Support regulatory document creation including BLA submission and lead response authoring to regulatory questions (RTQ)
Train colleagues with MSAT processes as needed.
Manage the work of junior members of the team when needed.
Flexible and able to adapt to company growth and evolving responsibilities.
10-20% travel anticipated.
Desired Education and Skills:
Advanced degree in Engineering or Life/Pharmaceutical Sciences.
8+ years of process development, MSAT, and/or manufacturing experience.
Demonstrated understanding of regulatory and cGMP requirements
Experience with risk assessments, technology transfer, and commercial manufacturing operations.
Knowledge of regulatory, validation, and documentation requirements for product development, commercial production, and site transfer.
Strong skills in data trending and analysis using statistical software.
Strong collaborative and communication skills, and the ability to work well in a cross-functional, matrixed environment are essential.
Ability to prioritize and perform multiple tasks.
#LI-Hybrid
This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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