Nexcella, Inc.
Quality Assurance Lead, GMP Cell Therapy Manufacturing (CAR-T)
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- United States
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- United States
À propos
Quality Assurance Lead, GMP Cell Therapy Manufacturing (CAR-T) Nexcella, Inc.
(a subsidiary of Immix Biopharma, Inc.) Location : Northern California. Full-time. On-site. Our 3 Core Values Integrity Initiative What You'll Do - The Quality Assurance (QA) for Cell Therapy Manufacturing will be a key team member for QA oversight of clinical trial drug production - QA Operations will be responsible for completing real-time initial reviews of product batch records and QC testing records, as well as providing feedback to manufacturing and QC. - Oversees apheresis receipt and product shipments, provides QA support in cleanrooms, prints, reviews, and reconciles labels, initiates identified deviations, supports quality audit activities including regulatory inspections and internal audits, reviews, creates, revises and implements quality assurance standard operation procedures and work instructions for the site when necessary. - Supports the Quality System team, as needed, with emphasis on the following processes: Change Control, Deviation, Training, and CAPA. - Ensures Manufacturing operation is inspection-ready and directly supports inspection activities. - Supports the documentation lifecycle management, including document creation, review, approval, and submission for retention. - Supports internal audits and assists regulatory inspections (e.g., prep room participant, scribe) - Drives continuous improvement efforts regarding Operations as it relates to Quality Management processes by identifying improvement opportunities and presenting solutions to the improvement opportunities. Skills and Experience We Look For -BS Degree in Biology, Microbiology, Biochemistry, or other life sciences -3+ years of experience in QA, QC, Manufacturing, or GMP environment -Working experience in Cell Therapy is highly desired -General knowledge of aseptic manufacturing process -Working knowledge of GMP Regulations and ICH Guidelines governing current Good Manufacturing Practices for Pharmaceuticals and Biotechnologies -Strong attention to detail Rewards at Nexcella Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits. Compensation will be commensurate with experience. Our compensation package also includes an annual bonus based on company goals and an equity grant. Our benefits package includes: coverage for medical, dental and vision for team members and dependents and 401k.u Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.nexcella.com and www.BeProactiveInAL.com. Employment Type Full-time Seniority level
Seniority level Mid-Senior level Employment type
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Compétences idéales
- Quality Control
Expérience professionnelle
- QA
Compétences linguistiques
- English