Principal Scientist - Biologics

We are recruiting for a Principal Scientist on a 12 month contract basis (extensions in place) to design, perform and report results of scientific experiments within Biologics. This role requires Technical writing skills and you will be involved in working closely with external suppliers for project related activities.

There are two positions available:

- EXTERNAL CMO & LAUNCH SITE MANAGEMENT FOR QUALITY RELATED TOPICS
- SUPPORT FOT GLOBAL LIMS IMPLEMENTATION (SCRIPT PREPARATION, TESTING, DATA MIGRATION, ...) THIS ONE IS MORE RELATED TO LAB SOFTWARE VALIDATION ACTIVITIES.

Profiles with experience of management of external sites or with experience in CSV are very much welcome. GERMAN IS A MUST.

Responsibilities:

- Contribute to the setup and optimization of infrastructure or specialized facilities eg cell culture or biosafety labs as an expert.
- Generate scientific documents to hand over to internal and external partners (eg, CMO, TechOps, authorities, external companies)
- Support generation of international registration documents.
- Contribute to risk analyses
- Collaborate with other groups/functions to facilitate validations, transfer of knowledge, analytical procedures and deliveries Biological Drug Substances and Drug Products.
- Give guidance to team members and work according to appropriate SOP's, GMP, OQM, HSE, ISEC and company guidelines.
- Evaluate/qualify new lab equipment and prepare CAR and USR if applicable.
- Report and present scientific results internally and contribute to presentations.

Education:

Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).

Language:

German and English (oral and written)

Experience:

3+ years experience in an industrial setting or if you are a PhD graduate, experience as an intern is sufficient, however you must have cGMP experience.

Solid knowledge of cGMP

Broad scientific and technical knowledge within Biologics.

Adequate understanding of development/QC processes in own function.

Advanced knowledge of laboratory and/or technical tools.

Excellent technical writing skills.

Please get in touch with Luchele Mendes for further details or email: (see below).

Michael Bailey International is acting as an Employment Business in relation to this vacancy.