Cell Therapy Manufacturing Specialist
Há 7 dias
We are seeking a Cell Therapy Manufacturing Specialist to 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. The successful candidate will have a strong background in QA and experience in the biopharmaceutical or cell/gene therapy industry.
Key Responsibilities- Regulatory Compliance: Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories.
- Manufacturing Oversight: Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing.
- Quality Control: Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs.
- Production Lot Records: Review and approve production lot records for compliance prior to disposition.
- GMP Reviews: Perform GMP reviews of incoming documentation (batch records, test data, release packages).
- Issue Resolution: Ensure timely escalation and resolution of manufacturing and quality issues.
- Cross-Functional Collaboration: Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings.
- 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.
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Cell Therapy Manufacturing Specialist
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São Paulo, São Paulo, Brasil beBeeManufacturing Tempo inteiro R$120.000 - R$160.000Cell Therapy Manufacturing SpecialistThis is a key role in our Cell Therapy Manufacturing team. The External Quality Assurance (EQA) Specialist will provide critical oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards.Review...
