Job Description

Compensation & Notes:

• Fully onsite position Mon-Fri in Gaithersburg, MD
• $45/hr-$48/hr- Exact compensation may vary based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Qualifications:

• Degree in a Science/Engineering-related field required, with preferred focus or experience in pharmaceutical manufacturing
• Minimum 3–5 years’ experience in pharmaceutical manufacturing, with preference in cell and gene therapy manufacturing
• Preferred experience working with the CliniMACS Prodigy Instrument
• Preferred experience with contract manufacturing organizations
• CAR-T experience

Job Description: This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase II/III clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting the contract manufacturing organization in the following activities:

• On-the-Floor Technical Support and Issue Triage (rapid response to manufacturing issues, resolution, and communication/escalation)
• Facility Oversight , including routine GEMBA walks, reporting of observations to the CMO, and supporting improvements where needed
• Technical Writing/Review for product impact assessments, investigations/deviations, and change controls
• Support in the execution and implementation of CAPAs
• Technical Writing/Review for batch records, SOPs, and other documents as needed
• Support in data transcription and analysis for manufacturing process and release data

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