Sr Specialist EU QA Operations CAR T, manufacturing, release and disposition support

Job Description

Just as Cell Therapy is redefining personalized medicine, we are creating the industry defining Cell Therapy Operations, for our patients, caregivers, providers and partners. Our global Cell Therapy Development and Operations team’s mission is to define and deliver the world’s most trusted cell therapy manufacturing and distribution network and to install and maintain the highest quality standards.

You will support in providing Quality oversight of Contract Manufacturing Organizations (CMOs) performing key manufacturing steps for CAR T products in Europe. The role will partner with the responsible Quality Manager and other internal stakeholders to maintain and improve the performance of our CMOs with focus on highest quality standards and GMP compliance. You will take responsibility for the review of batch records for clinical and commercial CAR T intermediate products and internal release for further processing. Furthermore, you will partner with the Quality manager, the patient Operations group and our external European distribution hub to ensure timely delivery of the cell therapy products to the treatment sites.

You will be a part in the process of building a team and governance model for our external European partners in order to ensure successful commercialization and highest quality of our CAR T products for the benefit of our patients.

Duties and Responsibilities

• Support Senior Quality manager in providing Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate product manufacturing
• Responsible for batch record review of intermediate product (Make 1) and preparation of system release
• Closing and remediation of detected gaps in collaboration with CMO
• Partner with CMO Quality to ensure a robust batch release process in accordance with agreed processes and defined timelines
• Oversee batch disposition status for European patients and ensuring availability and completeness of documentation required for final drug product release (QP release)
• Support in review and approval of CMO deviation investigations, CAPA, controlled documents (Master records)
• Support in review and approval of internal investigations and CAPA affecting the CMO
• Partner with stakeholders across different operational functions and participate in projects in order to improve processes
• Support and act in quality related improvement projects in collaboration with affected CMO functions
• Support Senior Quality manager in providing quality oversight of routine operations for EU distribution center responsible for import, disposition and distribution of finished cell therapy product (CAR-T) in EU
• Support in review and approval of deviation investigations, CAPA, change control, controlled documents linked to the European distribution center
• Partner with patient operations group for resolution of real time issues during last mile delivery to treatment sites

Required Qualifications

• Strong organizational skills, including ability to follow assignments through to completion.
• Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas or comparable education with experience in GMP industry.
• First experience in EU GMP regulated industry within in quality assurance, quality control, or manufacturing
• Knowledge of relevant regulations and guidance.
• Able to work independently and reliable with regards to quality and timeframes
• Very good verbal and written communication skills.
• Ability to work in cross-functional teams
• Fluent in English and German
• Experience within the Cellular Therapeutics environment is a real plus
• Experience with biological manufacturing and related documentation
• Ability to prioritize and successfully manage complex and competing tasks
• Detail-oriented with expertise in problem-solving and solid decision-making abilities.
• Ability to work in a fast-paced environment