Cell Therapy Manufacturing

1 semana atrás

Belo Horizonte, Brasil Nexcella, Inc. Tempo inteiro

Cell Therapy Manufacturing - External Supplier Quality Management (SQM) Associate Nexcella, Inc.
Sao Paulo / Hybrid Our 3 Core Values Intelligence Integrity Initiative What You'll Do The Supplier Quality Management (SQM) role will be responsible for the oversight of external suppliers, including Clinical and CMC vendors.
The individual will establish and maintain a compliant supplier quality program, perform and/or coordinate supplier audits, and ensure vendor compliance with regulatory and company requirements.
Key Responsibilities Manage Quality oversight of Clinical and CMC suppliers (raw material suppliers, CROs, CDMOs, testing laboratories).
Conduct initial supplier quality assessments, vendor qualifications, and risk-based evaluations.
Identify and determine audit requirements for critical and high risk suppliers.
Develop audit schedules and perform on site and remote audits to assess supplier compliance with cGMP/GCP/GLP.
Ensure timely closure of supplier audit findings and CAPA follow up.
Maintain approved vendor list (AVL) and vendor quality agreements.
Partner with Procurement, Clinical, and Technical Operations teams to manage supplier performance.
Provide training and guidance on supplier quality management to internal stakeholders.
Qualifications Bachelor's degree in Life Sciences 4–6 years of experience in supplier quality management within the pharmaceutical/biotech sector.
Strong knowledge of ICH Q10, ICH E6 (R2), and global supplier management expectations.
Demonstrated experience in conducting audits (GMP/GCP).
Excellent organizational and negotiation skills.
· Willingness to travel (10–20%) for site/vendor audits.
About Nexcella, Inc.
Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), 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 with a "digital filter" that filters out non-specific activation.
NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design.
Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center.
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.
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