Process Investigator
il y a 2 semaines
The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.
Key Responsibilities:
The Process Investigator is the role for providing quality investigation insights over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes assessing process information, reviewing in-the-field manufacturing investigations, follow up on various departmental post-implementation optimizations and tracking of quality metrics while ensuring high quality and compliant product supply.
Qualifications
Education:
- A Bachelor's degree in Molecular Biology, Cell Biology, Biochemistry or related area in the Life Sciences is required. A Masters Degree in the aforementioned or related fields is preferrable.
- Experience in an industrial manufacturing or regulated environment is required
- Strong working knowledge of current Good Manufacturing Practices (cGMP)
- Experience working in a controlled, cleanroom environment under aseptic conditions is required
Qualifications:
Required:
- Collaborate with manufacturing teams to provide guidance and determine resolution for manufacturing issues/deviations.
- Ensure accurate and timely reviews of manufacturing investigations, CAPAs, change controls and complaints.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to cell based product manufacturing or cell processing.
- Perform analysis on quality indicating data and identifying trends.
- Collaborates with functional departments to resolve issues.
- Contribute to crossfunctional projects/teams with many stakeholders.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Require mínimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
- Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
- Drive continuous quality improvements.
Preferred:
- The individual will communicate effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best
- Ability to summarize and present results, and experience with teambased collaborations is a requirement.
- Ability to identify/remediate gaps in processes or systems with correct follow up by effectiviness checks.
- Good team mentality, strong technical skills and the ability to contribute succesfully in line with specific milestone schedule is preferred.
Other:
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to pay attention to details and follow the procedures.
- Good written and verbal communication skills are required.
- Ability to work with others in a team environment.
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