BrainChild Bio is seeking a Senior Specialist, Quality Assurance, to serve as our on-site Quality representative at our contract manufacturing partner (CDMO). This role will act as BrainChild Bio’s primary Quality presence at our CDMO, providing Quality Assurance oversight and support of all BrainChild Bio-related activities. The Senior Specialist will provide operational Quality support at the CDMO and act as a project manager, coordinating with BrainChild Bio’s Patient Operations team to track status of in-process autologous CAR T batches. Key responsibilities include timely lot disposition and shipment, upcoming batch readiness, and comprehensive Quality and Operations support for in-process lots.
The ideal candidate brings Quality Assurance experience, strong organizational and project management skills, and exceptional communication. We’re seeking a collaborative leader who can orchestrate cross-functional, complex workflows with our CDMO, hold themselves and others to the highest standards of compliance, and help bring BrainChild Bio’s life-changing therapies to patients.
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Responsibilities:
Represent BrainChild Bio at our CDMO partner as the lead for documentation review, lot disposition, and deviation and investigational support.
Work with the CDMO to track manufacturing, testing, and release operations to drive compliant and consistent cadence of operations and delivery of product to patients.
Provide appropriate oversight and ensure compliance with all applicable GMP regulations at BrainChild Bio and our CDMO.
Partner with BrainChild Bio Quality, Patient Operations, and Program Management leadership to manage and track key quality system metrics, analytics, and reports pertaining to BrainChild Bio product manufacturing and proactively identify and propose potential solutions to address issues.
Deliver Quality guidance to BrainChild Bio program teams during manufacturing activities and product development.
Compile and deliver information for routine Quality Management Reviews with senior leadership.
Participate in and bring an active voice to inspection readiness activities as BrainChild Bio and the CDMO partner build toward late stage clinical and commercial readiness.
Qualifications:
5+ years of experience in a Quality role in the biotech/cell therapy industry.
1+ years supporting manufacturing operations in a Quality role.
Knowledge and application experience of cGMPs in biotech manufacturing.
Strong communication skills and robust project management skills.
Audit experience, leading and participation in, a plus.
Ability to deliver in a fast paced, small company environment and adjust workload based on shifting priorities and needs.
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$150,000 - $190,000 a year
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