Cell Therapy Manufacturing Specialist

Há 13 horas

São Paulo, São Paulo, Brasil beBeeManufacturing Tempo inteiro R$900.000 - R$1.500.000

Job Summary:

The Cell Therapy Manufacturing Specialist plays a pivotal role in ensuring the quality and compliance of external Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories.

  • This individual will oversee the review and approval of deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories to guarantee adherence to cGMP, regulatory requirements, and company quality standards.
  • A key aspect of this role is monitoring manufacturing campaigns, production activities, and resolving issues during routine manufacturing operations to ensure seamless batch release.
  • The Specialist will also review and approve Quality Control/analytical results and Certificates of Analysis from CDMOs/external labs, as well as production lot records for compliance prior to disposition.
  • In addition, this position involves performing Good Manufacturing Practice (GMP) reviews of incoming documentation, including batch records, test data, and release packages, to guarantee accuracy and completeness.
  • The successful candidate will be responsible for ensuring timely escalation and resolution of manufacturing and quality issues through collaboration with internal cross-functional teams.

Requirements:

  • Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or a related discipline.
  • Minimum 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 are essential for success in this role.

Key Skills:

  • Knowledge of regulatory requirements and guidelines.
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a team environment.
  • Effective communication and interpersonal skills.
  • Ability to prioritize tasks and manage multiple projects simultaneously.

About the Role:

This is an exciting opportunity for a motivated and detail-oriented individual to join our team as a Cell Therapy Manufacturing Specialist. If you have a strong background in QA and a passion for ensuring the highest quality products, we encourage you to apply.

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