Msat Scientist I

**About CCRM**:
**Department**: Deliver

Position Summary
This is a critical role that oversees all the cell and gene therapy GMP manufacturing Operations and technology transfer activities. As the Manufacturing Sciences and Technology (MSAT) Scientist I at OmniaBio, you are a seasoned individual in the field of GMP manufacturing of cell and gene therapy products who is driven by the opportunity to enable the clinical translation of cell therapy and regenerative medicine. This challenging position is available in the process transfer and support function of MSAT at our CCVP facility.
This position is responsible for being the primary technical support person for manufacturing processes. This position needs to thoroughly understand the manufacturing process, aseptic handlings, process mapping, risk analysis, process implementation and other technology transfer related issues.
The MSAT Scientist I is expected to actively participate in planning and problem-solving of technology transfer related issues. Our MSAT Scientist I is responsible for the execution of all the technology transfer studies in support of cGMP activities at GMP manufacturing. The MSAT Scientist I will work in cooperation with other departments during the technology transfer and the individual will be involved in training other MSAT associates.

**Responsibilities**:

- Execution of MSAT laboratory studies in the Lab to support cGMP activities for upstream viral vector manufacturing at small and large scale.
- Drives independently process transfer and continued process support as per agreed timeline in close collaboration with internal and external parties
- To be accountable for the introduction and support of qualification of new process technologies into cGMP manufacturing, whilst managing technical risks associated with process transfer.
- Review client manufacturing process or SOPs, Bill of Equipment and Bill of materials for GMP manufacturing compliance.
- Identify risks and develop mitigation plans in the upstream process and enable quick and robust decision making through efficient team collaboration
- Responsible for analyzing and managing the risks associated with process transfer, and the introduction of new raw materials for both pilot and production scale batches, transfer complex processes from international development and pilot scale facilities.
- Performs all functions associated with process transfer and process support, e.g., develop process understanding, perform gap analysis / Failure Mode Effects Analysis (FMEA), generate process models, author / review process descriptions and Batch Records, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation). May provide guidance on process transfer and support activities to members of the team.
- Prepare or review User require specification (URS) of all the new equipment’s and work closely with CQV and facility team to perform risk assessment or impact assessment of introducing new technology or an equipment.
- Ensures major steps of process transfer including feasibility run, Engineering runs, and APS runs are performed successfully
- Actively participates in troubleshooting and serves as investigation lead for process impacting deviations and investigations.
- Provides technical guidance on change controls and how they might impact customer processes.
- Assess all major deviations including those that impact product quality. Identifies potential root causes using a systematic approach. Able to identify potential solutions. Performs or is able to understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.
- Provides support for the manufacturing floor regarding pre-campaign training, support during critical manufacturing operations, troubleshooting, etc.
- To be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applied to process innovation, cost, or yield improvement.
- Keeps current with advances in cell and gene therapy field
- Strongly collaborates with process development teams on improving the performance of the team
- Pro-actively provides training and guidance to other MSAT associates must be able to independently perform deliverables assigned to the individual
- The position requires extensive knowledge in the field of cell and gene therapy and applicable technologies, GMP, ATMP and aseptic manufacturing
- This position requires experience in working in a fast-paced environment and demonstrating professional response to unexpected events
- Primary lead on projects related to induced pluripotent reprogramming, immune-oncology, viral vector production etc.

**Requirements**:

- BSc with 6+ years of experience in Biological Sciences, Biomedical/Chemical Engineering/GMP, or another relevant field; MSc with 5+ years of experience or PhD with 4+ years of experience in Biological S