Sigmar are looking for a Pharmaceutical Technology Specialist for a competitive pharmaceutical fast-growing multinational company.
As Pharmaceutical Technology Specialist you will be part of the Technology Transfer Team for the introduction of new products. For that, your mains duties will be:
- Part of the cross-functional technology transfer team with the scope of regenerative medicine manufacturing
- Tracking activities on the Tech Transfer Schedule
- Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
- Accompany and supervise development, transfer, validation and process optimization operations in an aseptic manufacturing environment.
- Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
- Planning, implementation and evaluation of experimental programs about the manufacturing process incl. design of experiment, continuous process verification and process capability evaluation.
- Execute, lead and participate in risk assessments associated with technology transfer of the process
- Manufacturing and process subject matter expert with regard to aseptic manufacturing, bioprocessing and regenerative medicines; Participate in and support regulatory audits
- Assist with the process validation and tech transfer runs.
- Support P3 operations team with achieving overall operational readiness schedule adherence.
- Complete required documentation and change controls relating to technology transfer, development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) Technology Transfer Plan, BMRs, SOP, Logbooks and EOPs.
- Support investigations in manufacturing and technical deviations.
- Ensure that appropriate validations are in place in the area of responsibility (e.g. process validation, cleaning validation, aseptic validation)
The next Pharmaceutical Technology Specialist must have a degree in Science, Engineering or Chemistry degree, 2 years’ experience in Pharma Manufacturing including technology transfer preferably in the pharmaceutical, biopharmaceutical or biotechnology industry. A good knowledge of manufacturing operations, Quality and Regulatory Affairs are appreciated.
- Good communicator, self-organized, trouble shooting and problem-solving skills
- Detailed knowledge in experimental design, statistical data analysis and quality by design
Do you want to take a new path on your career? Are you looking for an innovative environment to work on while having career progression opportunity? Don’t wait any longer, send us your CV!
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