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Senior Scientist - Large Molecules
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support
Projektbeschreibung
I am looking for a PhD graduate/Scientist within Biologics who will be managing third party suppliers. You will use your multilingual skills to communicate and share information with external partners, therefore fluent German and English are a must.
GMP experience is an absolute must.
Responsibilities
- Be responsible for the incoming data from external partners
- Reports/data need to be verified for accuracy and compliance and processed internally onto the company data system.
- Open effective networks of communication with external partners for additional clarification and data integrity.
- Generate scientific documents to hand over to internal and/or external partners (eg, TechOps, authorities, external companies) and support generation of international registration documents under adequate guidance from more experienced team members.
- This role is complex as you will be interacting with a huge and varied amount of testing sites and therefore need to be flexible, approachable and well-organised.
- Due to strict deadlines, the ideal candidate will be very well organised with time keeping and will be able to work under pressure well.
Other Responsibilities:
- Provide scientific and technical guidance. Coach team members as needed.
- Contributes to the setup and optimization of infrastructure or specialized facilities eg cell culture or biosafety labs as an expert.
- Contribute to risk analyses and/or peer review and project challenge meetings.
- Interact/collaborate with other groups/functions to facilitate validations, transfer of knowledge/analytical procedures and deliveries of DS and/or DP.
- Give guidance to team members and work according to appropriate SOP's, GMP, OQM, HSE, ISEC and Novartis guidelines.
- Work according to appropriate SOPs, GMP, QM, HSE, ISEC & Novartis Guidelines.
Requirements
- Successfully demonstrated several years (minimum of 3 years) of directly related experience as scientist or Ph.D. (0 years' experience) or equivalent.
- Solid knowledge of cGMP
- Broad scientific or technical knowledge in a specific area.
- Adequate understanding of development/QC processes in own function.
- German and English (oral and written)
Email: luchele.mendes (at the rate of) or call.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
GMP experience is an absolute must.
Responsibilities
- Be responsible for the incoming data from external partners
- Reports/data need to be verified for accuracy and compliance and processed internally onto the company data system.
- Open effective networks of communication with external partners for additional clarification and data integrity.
- Generate scientific documents to hand over to internal and/or external partners (eg, TechOps, authorities, external companies) and support generation of international registration documents under adequate guidance from more experienced team members.
- This role is complex as you will be interacting with a huge and varied amount of testing sites and therefore need to be flexible, approachable and well-organised.
- Due to strict deadlines, the ideal candidate will be very well organised with time keeping and will be able to work under pressure well.
Other Responsibilities:
- Provide scientific and technical guidance. Coach team members as needed.
- Contributes to the setup and optimization of infrastructure or specialized facilities eg cell culture or biosafety labs as an expert.
- Contribute to risk analyses and/or peer review and project challenge meetings.
- Interact/collaborate with other groups/functions to facilitate validations, transfer of knowledge/analytical procedures and deliveries of DS and/or DP.
- Give guidance to team members and work according to appropriate SOP's, GMP, OQM, HSE, ISEC and Novartis guidelines.
- Work according to appropriate SOPs, GMP, QM, HSE, ISEC & Novartis Guidelines.
Requirements
- Successfully demonstrated several years (minimum of 3 years) of directly related experience as scientist or Ph.D. (0 years' experience) or equivalent.
- Solid knowledge of cGMP
- Broad scientific or technical knowledge in a specific area.
- Adequate understanding of development/QC processes in own function.
- German and English (oral and written)
Email: luchele.mendes (at the rate of) or call.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges