Jobs at SOKOL GxP Services

Support Manufacturing Engineering by formatting, editing, uploading, routing, and tracking controlled documents in Veeva/EDMS. Ensure adherence to templates, formatting standards, and approval workflows; improve clarity and consistency without authoring technical content.

Lead end-to-end UX research and design activities: plan and conduct user and stakeholder interviews, workflow analysis, and usability testing. Synthesize insights into UX strategies, map complex workflows, and create low-to-high-fidelity interaction and UI designs in Figma. Collaborate with product, engineering, data, IT, and business partners to ensure feasible, scalable solutions; may act as sole UX resource on projects.

Author and co-author CMC regulatory documentation (Module 2.3 and Module 3) for a late-stage cell therapy program. Coordinate source documents, manage submission timelines, review and adjudicate comments, verify data, ensure dossier consistency, and collaborate cross-functionally with development, quality, regulatory, project management, document management, and external vendors.

Provide on-the-floor QA support for biopharmaceutical manufacturing: perform real-time batch record reviews, approve shop-floor documentation, identify and escalate quality issues, support deviations/change control/CAPA, apply Quality Risk Management, and develop/revise GMP procedures while partnering with manufacturing and cross-functional teams.

Hands-on role to design, program, qualify, and optimize automated QC assay workflows for cell therapy products using liquid handlers. Responsibilities include translating manual assays to automation, troubleshooting scripts/instruments, supporting method qualification/validation, authoring GMP documentation, and collaborating with QC, analytical development, and automation teams to enable technical transfer and continuous improvement.

Provide administrative and project support to senior leaders across multi-site biologics development teams. Manage complex calendars, meetings, travel, expense reports, onboarding/offboarding, SharePoint and OneNote documentation, town halls, communications, and Microsoft-based survey and documentation tools while maintaining confidentiality and cross-site coordination.