Cell Therapy Manufacturing Specialist

As a manufacturing specialist, you will play a crucial role in the success of our cell therapy operations.

This is a highly regulated process that demands meticulous oversight to ensure compliance with cGMP and regulatory requirements.We are seeking an external quality assurance (EQA) specialist who can support ongoing manufacturing campaigns, batch release, and resolve quality events in a timely manner.You will be responsible for reviewing and approving deviations, out-of-specification (OOS) investigations, CAPAs, and change controls from contract development and manufacturing organizations (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).

Evaluate the effectiveness of existing procedures and suggest improvements to enhance overall efficiency and quality.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.To succeed in this role, you should possess a Bachelor's degree in life sciences, chemistry, biochemistry, engineering, or a related discipline.

Additionally, 3–5 years of QA experience in the biopharmaceutical or cell / gene therapy industry is required.The ideal candidate will have strong knowledge of cGMP, ICH Q7 / Q10, FDA 21 CFR Parts 210 / 211, and experience with CDMO oversight, lot release, and deviation management.A bachelor's degree and relevant work experience are required.

You must also possess excellent communication and problem-solving skills.This role offers a unique opportunity to grow your career in a dynamic and fast-paced industry.Key Responsibilities : CAPA ManagementOOS InvestigationsDeviation ManagementLot ReleaseQuality AssuranceRequired Qualifications : Bachelor's degree in life sciences, chemistry, biochemistry, engineering, or a related discipline3–5 years of QA experience in the biopharmaceutical or cell / gene therapy industryStrong knowledge of cGMP, ICH Q7 / Q10, FDA 21 CFR Parts 210 / 211Experience with CDMO oversight, lot release, and deviation managementExcellent communication and problem-solving skills