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Spark Therapeutics, Inc
Posted on Mar 8
The MS&T Engineer is a critical role within the Manufacturing Science and Technology (MS&T) Function supporting internal and external drug substance and drug product manufacturing. This individual has responsibility for developing and executing on a range of technical capabilities across the lifecycle of products that the team supports. These capabilities include Process Validation (incl. Continued Process Verification program administration), CMC Regulatory support, technical protocol authoring, deviation investigation, process troubleshooting, process and material characterization and overall knowledge management. The incumbent will collaborate with Process Sciences Leader(s) to build capabilities in the MS&T organization in support of progressing Spark’s pipeline through the process/product life cycle.
Capability Development and Execution:
Responsible for Technology Transfer Procedures, Manufacturing Batch Records, Process SOPs, Process Validation Protocols, Process Characterization Summary Reports, and any process related compliance documents
Design characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being
Knowledge Management, Process Improvement and Robustness:
Process Characterization, Process Validation / Continued Process Verification
In collaboration with Process Development, evaluate and propose changes to process/technology to improve compliance or efficiency. Implement strategies relating to new process improvements and capital investments.
Write, Review deviations pertaining to manufacturing processes, facility, and raw materials
Lead Root Cause Analysis and Risk Assessments and address gap assessments in preparation for GMP Manufacturing
The position requires extensive knowledge and experience with technical capabilities in support of cGMP upstream and downstream manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
Demonstrated ability to lead capability development and matrix technical teams to achieve objectives. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution
Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
Participates in the budget development process; effectively controls the controllable expenses (OT, Supplies, T&E) within their influence.
Experience with SAS JMP and OSI Pi a plus.
BS/MS/PhD in Chemical or Biochemical Engineering or related field required.
Generally has 2-5 years of experience in the Biotechnology or Pharmaceutical industry
Experience in biopharmaceutical based GMP manufacturing science and technology including direct experience in cell culture, recovery and purification required
Demonstrated technical project management experience to develop project goals, deliverables and timelines
Experience with accelerated CMC development pathways a plus
Knowledge of GXP compliance
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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