Job Responsibilities:
* Support the development of the tech transfer program.
* Collaborate with the team and stakeholders to deliver GMP documents related to Tech Transfer, such as risk assessments, change controls, batch records, sampling plans, and Bills of Material.
* Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV.
* Contribute and support various teams as the Tech Transfer representative.
* Support the development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Assist in the development of future breakthrough business solutions to reduce overall effort and risk, optimizing these to facilitate rapid product launches and progress the team towards one-click tech transfer.
* Write and maintain BOMs (Bill of Material), EBRs (Paper), gBMR (MES), and SOPs/WIs.
* Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams.
* Show a desire for continuous learning, improvement, and development while approaching problems from new perspectives.
* Support the aggregation of process-related knowledge and centralize it for knowledge management.
Minimum Requirements:
* A degree qualification in a relevant field (Science/Technical).
* Work experience in the pharmaceutical or biotech industry.
* Familiarity with Unit Operations for mAb manufacturing.
* Basic knowledge of project management.
* Competent in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets, and DeltaV.
* Competency in the use of automated/digital systems such as DeltaV, MES, eVal, and SAP COMET.
* Experience managing a small project with a cross-functional group.
* Working knowledge of cGMP regulations.
* Understanding of the general principles of New Product Introduction (Tech Transfer).
Work Environment:
* Remote work possible.
* Multicultural environment.
#J-18808-Ljbffr