
Cell Therapy Manufacturing
1 semana atrás
Cell Therapy Manufacturing - External Quality Assurance (QA) Associate Nexcella, Inc.Sao Paulo / Hybrid Our 3 Core Values Intelligence Integrity Initiative What You'll Do The Specialist, External Quality Assurance (EQA) will provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards.This role is critical in supporting ongoing manufacturing campaigns, batch release, and ensuring timely resolution of quality events.Key Responsibilities Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories.Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing.Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs.Review and approve production lot records for compliance prior to disposition.Perform GMP reviews of incoming documentation (batch records, test data, release packages).Ensure timely escalation and resolution of manufacturing and quality issues.Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings.Support audit readiness activities for Regulatory Authority inspections.Qualifications Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline.3–5 years of QA experience in the biopharmaceutical or cell/gene therapy industry.Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211.Experience with CDMO oversight, lot release, and deviation management.Excellent communication and problem-solving skills.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.Learn more at and
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Cell Therapy Manufacturing
1 semana atrás
Belo Horizonte, Brasil Nexcella, Inc. Tempo inteiroCell 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...
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Cell Therapy Supply Chain Logistics Associate
2 semanas atrás
Belo Horizonte, Brasil Nexcella, Inc. Tempo inteiroCell Therapy Supply Chain Logistics Associate Nexcella, Inc.Sao Paulo / Hybrid Our 3 Core Values Intelligence Integrity Initiative What You'll Do Overseeing the patient journey from screening through treatment across CAR-T therapies You will work cross-functionally with internal and external stakeholders to ensure therapies reach patients as quickly and...
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Biotech Sales Specialist
2 semanas atrás
Belo Horizonte, Brasil Bebeegenetherapy Tempo inteiroJob Title: Biotech Sales SpecialistOverviewThis role involves promoting specialized biologic and gene therapy services, expanding market presence in Brazil.ResponsibilitiesVisit hospitals, clinics, biotech & pharmaceutical companies to promote gene therapy / vector development / GMP manufacturing capabilities.B uild and maintain strong relationships with Key...
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Medical Sales Representative
2 semanas atrás
Belo Horizonte, Brasil Mantell Associates Tempo inteiroMantell Associates is currently partnered with a leading CDMO specializing in gene therapy, who is seeking a driven and technically competent Medical Sales Representative to join its commercial team in Brazil. This is a field-based role focused on building strong relationships, promoting specialized biologic and gene therapy services, and expanding market...
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Cloud Engineer
Há 2 dias
belo horizonte, Brasil Aditi LATAM Tempo inteiroAditi Consulting - LATAM Elevate your career as a SR Cloud Engineer and join a dynamic, innovative team at Aditi Consulting. Our track record of deploying top-tier professionals has earned us recognition among America’s fastest-growing companies. As we continue to expand, seize the opportunity to grow and thrive in a supportive and forward-looking...
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Belo Horizonte, Brasil Aditi LATAM Tempo inteiroAditi Consulting - LATAM Elevate your career as a SR Cloud Engineer and join a dynamic, innovative team at Aditi Consulting. Our track record of deploying top-tier professionals has earned us recognition among America’s fastest-growing companies. As we continue to expand, seize the opportunity to grow and thrive in a supportive and forward-looking...
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Cloud Engineer
Há 3 dias
Belo Horizonte, Brasil Aditi LATAM Tempo inteiroAditi Consulting - LATAM Elevate your career as aSR Cloud Engineerand join a dynamic, innovative team at Aditi Consulting. Our track record of deploying top-tier professionals has earned us recognition among America’s fastest-growing companies. As we continue to expand, seize the opportunity to grow and thrive in a supportive and forward-looking...
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Junior Python Developer
Há 6 dias
Belo Horizonte, Brasil Aditi Latam Tempo inteiroAditi Consulting - LATAM Elevate your career as a Junior Python Developer and join a dynamic, innovative team at Aditi Consulting.Our track record of deploying top-tier professionals has earned us recognition among America's fastest-growing companies.As we continue to expand, seize the opportunity to grow and thrive in a supportive and forward-looking...
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Junior Python Developer
Há 6 dias
Belo Horizonte, Brasil Aditi Latam Tempo inteiroAditi Consulting - LATAMElevate your career as aJunior Python Developerand join a dynamic, innovative team at Aditi Consulting. Our track record of deploying top-tier professionals has earned us recognition among America's fastest-growing companies. As we continue to expand, seize the opportunity to grow and thrive in a supportive and forward-looking...
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Cloud Engineer
Há 2 dias
Belo Horizonte, Brasil Aditi LATAM Tempo inteiroAditi Consulting - LATAM Elevate your career as a SR Cloud Engineer and join a dynamic, innovative team at Aditi Consulting. Our track record of deploying top-tier professionals has earned us recognition among America’s fastest-growing companies. As we continue to expand, seize the opportunity to grow and thrive in a supportive and forward-looking...