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Coordinate and lead activities related to DSP data analyzes related to the production of monoclonal antibodies at DSP stages as part of process transfer, process scaling, GMP production and process validation. Participation in the transfer of technology/process validation in accordance with cGMP and internal regulations in the implementation of projects related to the introduction of new biotech products.
- Collect DSP data (process data / QC data) in consistent manner, Batch Data Review and Trending.
- DSP Batch Record Data Review and Assessment.
- Supporting deviations investigation, change control assessment, CAPA implementation concerning process transfer, validation and GMP batches.
- Review/participation in preparation of the DSP documentation (protocols, reports, risk assessments, process descriptions).
- Review of the DSP documentation package delivered by the Sending Unit including Review of Process Characterisation Studies & SDMQ.
- Set up and coordination of DSP Lessons Learned Sessions post-process transfer.
- DSP CDMO evaluation/feasibility assessment preparation.
- Generate/review DSP PV documentation including protocols, Risk Assessments related to PV, reports.
- Review and support definition of CPP and KPP and Process Control Strategy.
- Documents preparation, supervision of the study and control of sampling during the execution of concurrent resin study .
- Support or generation of DSP Batch Reports Review/participation in preparation (process parameters/ QC data) of the Batch records templates.
- Participation in DSP RCI for deviations.
- Collaborations with DSP TR&D for investigative studies.
- Participation in DSP technical trial design.
- Participation in/ proposing of process optimization to reduce time, resource, cost.
- Use existing knowledge to resolve routine process issues and support Production.
- Perform other duties related to MS&T department as assigned by supervisor.
- Completed studies in biotechnology, pharmacy or related discipline.
- 6 years of experience in the production of biotechnology products at production or development scale, participation in the transfer and scale up activities of production processes related to DSP stages of the cell culture manufacturing process and or microbial manufacturing process.
- Experience with working in cGMP environment.
- Ideally experience with process validation according to FDA and EMEA guidelines.
- Experience with single-use technology.
- Fluent English.
- Good knowledge of cGMP and FDA requirements for biologics manufacturing, validation and technology transfer requirements.
- Ability to work in a fast paced and priority changing environment without sacrificing accuracy, quality of work, and safety.
- Good problem-solving skills.
- Skilful in problem solving and trouble-shooting data, equipment, and procedures at various process scales.
- Good organizational and time management skills.
- Excellent written and verbal communication; and the ability to work both independently in a multi-disciplinary environment and as a key teammate within an interdisciplinary team.
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