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Job Summary
We are seeking a motivated and detail-oriented MSAT Technical Associate II to join our Manufacturing Science and Technology (MSAT) team. In this role, you will play a key part in supporting process validation activities and Continued Process Verification (CPV) for our advanced cell and gene therapy manufacturing processes. You will collaborate cross-functionally with Process Development, Manufacturing, Quality Assurance, and Quality Control to ensure processes are robust, compliant, and capable of consistently delivering high-quality products. This is a hands-on technical role ideal for someone passionate about data-driven decision-making and continuous improvement in a GMP environment.
The Autolus MSAT team primarily supports Manufacturing Operations in providing front line expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to GMPs, SOPs and applicable guidelines and functional standards. This role is a great opportunity to develop key skills and grow within MSATs subgroups supporting technology transfer and introduction of new process, material, equipment, continuous improvement and automation projects, data science with continued process verification. The ideal candidate will have experience in Advanced Therapy Medicinal Product manufacturing and the role will be based between Stevenage and occasional work in London.
Key Responsibilities
- Provide frontline technical and scientific support as Subject Matter Expert (SME) in the manufacturing processes, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the standard procedures and quality requirements
- Provide on-call and on the floor support during technology transfer and routine manufacturing
- Provide product impact assessments and root cause analysis for less complex deviations, write and implement suitable corrective and preventative actions
- Contribute to commercial readiness activities
- Contribute to (risk) assessment of technical changes to ensure adherence to process specification and process control strategy and alignment of with batch records and procedures
- Review documentation such as batch manufacturing records, bill of materials, sampling plans, and material specifications
- Contribute with the assessment of new equipment and materials for GMP implementation
- Contribute to the change implementation of simpler MSAT-owned projects and execution of process improvements
- Contribute to data entry and verification of process parameters for the purpose of data analysis, monitoring, and trending to ensure that the products manufactured conform to expected critical process parameters and set product specifications
- Represent MSAT as an SME on smaller cross functional teams and projects
- Contribute to the execution of technology transfer of new products from process development into GMP manufacturing
- Other duties as required
E- Essential
Demonstrated skills and competencies
Experience
P- Preferred
- 2-5 years experience in GMP manufacturing (E)
- Experience in equipment and/or processes in a GMP manufacturing environment (P)
- Experience in Advanced Therapy Medicinal Product manufacturing (P)
- Experience in technology transfer and process/product lifecycle management (P)
Qualifications
- Bachelors degree in science, engineering, or relevant degree (P)
Skills/Specialist Knowledge
- Knowledge and understanding of Good Manufacturing Practices (GMP) (E)
- Excellent technical writing skills, strong communication and interpersonal skills with ability to work independently and cross functionally with internal and external stakeholders(E)
- Key attributes such as simplifying the complex, making data-driven decisions, problem solving, and collaborating cross functionally (E)
- Problem solving mindset with the ability to shift focus based on changing priorities(E)
- Knowledge and understanding of regulatory policies (P)
- Experience working in cross functional technical transfer activities with ability to multitask, prioritize and be an effective decision maker (P)
- Experience in Quality Management Systems, initiation/owning and completing deviations, change controls and CAPAs (P)
- Experience in writing or revising procedures to support project implementation and process improvement initiatives (P)
- Utilize and incorporate principles of Lean, Six Sigma, or other relevant operational excellence methodologies to the manufacturing processes (P)
- Experience and interest in biotechnology, pharmaceutical or cell and gene therapy industry (P)
- Experience in aseptic processing, cell culture and downstream processing (P)
- Experience in data analysis tools and data management platforms(P)
- Experience in automation projects (P)
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