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Manufacturing Science and Technology Expert
vor 2 Monaten
Job Summary
Johnson & Johnson CH is seeking a skilled Manufacturing Science and Technology Expert to establish expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals.
Key Responsibilities
- Represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.
- Ensure timely plant readiness to support experimental / clinical activities.
- Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD).
- Support scale-up and Tech-Transfer.
- Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements.
- Ensure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations.
- Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents.
- Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation.
- Prepare business plan forecasts and monitor actual spend vs budget.
Requirements
- You have a degree in Pharmaceutical/Biochemical/Life Science/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (5+ years) OR a PhD with proven experience (3+ years).
- Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful.
- Demonstrated proficiency and experience of biopharmaceutical process design is helpful.
- Solid understanding and experience of technology transfer operations and/or experience in fill/finish operations and/or understanding and experience in device assembly are highly appreciated.
- Proven track record of creativity and problem solving.
- Ability to collaborate with cross-functional teams is a must.
- Excellent oral and written language skills in English and German (at least intermediate) are required.
