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Principal Scientist

Eingestellt von Michael Bailey Associates - Munich

Gesuchte Skills: Support, Sap

Projektbeschreibung

An interfacing role between 5 different groups within the Early Phase Development (EPD) department. Initially you will be reporting to the Cell Process Development group head focusing on development of cell processes for cell therapy applications. In this context you will also interact with the pharmaceutical development leader in order to identify raw materials (excipients) required for formulation of cells.

Responsibilities:

o Identify and select primary tissue centres based on their certifications, geographical location and availability of samples
o Support setup of contracts and budget
o Support primary tissue collection and testing requirements
o Close collaboration with tissue suppliers, labs and CMO regarding the timing of fresh tissue arrival and experimental execution
o Support primary tissue global shipments (SPOC) from vendor to processing site and from processing site to clinic (shipping studies)
o Define all import administrative requirements (international procedures for tissue handling)
o Review and assess each raw material used for the manufacturing process: raw materials need to be selected upon their effectiveness in the process, their quality, their availability and the capacity of the supplier to provide all required documentation confirming safety and traceability of the raw materials and ingredients used during manufacturing
o For each raw material: specifications and release testing need to be defined, tested, validated in order to assure compliance with GMP of incoming raw materials for future GMP production.
o Act as a SPOC for raw material and equipment vendors: keep tracking materials upgrades and organize with development team trials.
o Define purchasing strategy: volumes, shipment, COGS negotiations
o Establish relationship with all raw material specialized suppliers for cell culture, cell selection and formulation
o Management and review of supporting documentation for raw materials for IND submissions and supply part
o Support purchase of equipment with vendors and procurement (PO, Licenses, contracts etc.)

Major accountabilities (as excipient sPoC):

o Support of supplier qualification for new excipients
o Integration of novel excipients into SAP landscape
o Assessment of impact of changes in excipient suppliers/excipient qualities
o Forecasting of excipient needs for GMP- and non-GMP production

Education:

o Master degree with 1-3 years of relevant experience
o BSC with at least 5-8 years of relevant experience
o Degree should be in life sciences: Biotechnology, Biochemistry, Pharmaceutical Sciences etc.

Language:

Established communication skills: FLUENCY IN GERMAN, ENGLISH, ORALLY AND IN WRITING.

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

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    08/2018

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    SAP Entwicklung, Sonstiges

  • Skills:

    support, sap

Michael Bailey Associates - Munich