Senior Engineer/Manager, Process Validation

<div class="content-intro"><p><strong><u>About Stoke:</u></strong></p> <p>Stoke Therapeutics&nbsp;(Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in&nbsp;Bedford, Massachusetts. For more information, visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.stoketherapeutics.com%2F&amp;esheet=54531662&amp;newsitemid=20260507458327&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.stoketherapeutics.com%2F&amp;index=10&amp;md5=10ebc704bd2cecf44bfb9eaaa83a686c">https://www.stoketherapeutics.com/</a></p></div><p><strong><u>Position Purpose:</u></strong></p> <p>The Senior Engineer/Manager, Process Validation will lead and manage various process validation activities for drug substance (DS) and drug product (DP) manufacturing, label and secondary packaging, and shipping validation processes at Contract Manufacturing Organizations (CMOs). This role involves executing and overseeing process validation and related lifecycle activities to ensure compliance with Good Manufacturing Practices (GMP) and global regulatory requirements. This role requires collaboration across various departments, including Manufacturing, Supply Chain, Quality Assurance (QA), and Contract Manufacturing Organizations (CMOs), to ensure successful development and execution of all validation activities.</p> <p>This position will report to the Director of Manufacturing Validation.</p> <p><strong><u>Key Responsibilities:</u></strong></p> <ul> <li>Lead and execute complex validation projects, including process, labeling/packaging, and shipping validation.</li> <li>Develop and implement process validation master plans (PVMPs), risk assessments, and validation strategies aligned with lifecycle and quality-by-design (QbD) principles.</li> <li>Coordinate with CMOs and internal teams to plan, execute, and review validation and qualification activities, ensuring consistent documentation and adherence to standards