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T-Cell Therapy Process Specialist

2 months ago


Frederick, Maryland, United States ApTask Full time
Client Overview:
Our client is a leading American biopharmaceutical organization dedicated to the advancement of groundbreaking therapies targeting a range of diseases, such as HIV, hepatitis, and influenza. With a robust focus on global health and enhancing medication accessibility, the company actively engages in research, acquisitions, and partnerships to broaden its therapeutic offerings.

Rate Range: $40-$43 per Hour

Job Description:
  • A biotechnology expert is sought to contribute to innovative T-Cell therapies aimed at cancer treatment.
  • Become a part of the Operations and Compliance Support team, focusing on the investigation and resolution of quality incidents in the production of engineered T-Cell therapy products.
Key Responsibilities:
  • Complete essential training to maintain technical expertise and ensure adherence to cGMP regulations.
  • Initiate quality documentation within the Veeva Quality Management System.
  • Facilitate cross-departmental meetings for root cause analysis.
  • Draft clear technical reports summarizing investigation findings.
  • Collaborate on Corrective and Preventive Actions (CAPA).
  • Oversee investigation timelines to align with compliance objectives.
  • Provide updates on progress to relevant stakeholders as necessary.
Requirements:
  • Bachelor's degree in a relevant discipline with a minimum of 2 years of experience, or equivalent qualifications.
  • Proficient technical writing, organizational, and root cause analysis capabilities.
  • Experience in cell culture or cGMP cell therapy manufacturing is preferred.
About ApTask:
ApTask is a worldwide provider of workforce solutions and talent acquisition services, specializing in staffing, IT consulting, project management, and more. As an African American-owned enterprise, ApTask emphasizes excellence, collaboration, and innovation, fostering opportunities for professional development and success across diverse industries.

Candidates may be required to participate in interviews either in person or via video conference. We prioritize data protection and confidentiality throughout the recruitment process. If you have any concerns regarding your privacy, please reach out to our compliance team.