USP Manufacturing Associate Scientist (m/f/d).

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  • categoria
    industria
  • Contatto
    Andreia Lourenço
  • riferimento
    129085-40299

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Within the Drug Substance Development (DSD) - Manufacturing department, we are looking for a "USP Manufacturing Associate Scientist " who will support the USP large-scale operations (GMP and pilot).

You will be part of a team of technicians, engineers and scientists specialized in the production and purification of recombinant proteins produced from animal cells.

You will support the USP activities from an operational and documentation point of view: cell expansion, bioreactor process in fed-batch/ perfusion.

You will support the activities related to the transfer of USP operations to the new site currently under construction. You will address various topics such as equipment, process and automation issues.

You will be responsible for:

- Performing operational USP activities

- Facilitating tech transfer and scaling-up

- You will be responsible for the analysis of data, be able to present it and interact with different entities: QC, QA or with the project managers.

- Carrying out the documentation related to your function, writing protocols, reports and procedures.

- Participating in maintaining the functionality of the laboratories/clean rooms.

- Supporting documentation activities related to your domain as well as compliance activities (deviations, CCP, investigations...).

- Participating in the continuous improvement of the area and its activities by proposing and participating in the implementation of improvement projects.

- Participating in test activities during the qualification of process equipment in the context of corrective or improvement changes if necessary

- Participating in the start-up of new equipment (qualification, validation) related to the launch of a new product.

Within the Drug Substance Development (DSD) - Manufacturing department, we are looking for a "USP Manufacturing Associate Scientist " who will support the USP large-scale operations (GMP and pilot).

You will be part of a team of technicians, engineers and scientists specialized in the production and purification of recombinant proteins produced from animal cells.

You will support the USP activities from an operational and documentation point of view: cell expansion, bioreactor process in fed-batch/ perfusion.

You will support the activities related to the transfer of USP operations to the new site currently under construction. You will address various topics such as equipment, process and automation issues.

You will be responsible for:

- Performing operational USP activities

- Facilitating tech transfer and scaling-up

- You will be responsible for the analysis of data, be able to present it and interact with different entities: QC, QA or with the project managers.

- Carrying out the documentation related to your function, writing protocols, reports and procedures.

- Participating in maintaining the functionality of the laboratories/clean rooms.

- Supporting documentation activities related to your domain as well as compliance activities (deviations, CCP, investigations...).

- Participating in the continuous improvement of the area and its activities by proposing and participating in the implementation of improvement projects.

- Participating in test activities during the qualification of process equipment in the context of corrective or improvement changes if necessary

- Participating in the start-up of new equipment (qualification, validation) related to the launch of a new product.

  • qualifiche

    - You have a technician diploma (CFC, HES, BTS, IUT...) with 5 years'experience in USP or an Engineering/ Master's degree in biochemistry/biology/ biotechnology or equivalent

    - You speak English and French (written and reading comprehension a plus)

    - Knowledge of USP processes is a must

    - Knowledge of BPF, GLP and/or GMP

    - Knowledge of IT tools (Pack Office, Trackwise/ SAP, DeltaV, MES, LIMS) is a plus

    - You are able to work as part of a team and have good communication skills with all stakeholders (Managers, Unit managers, scientists and technicians) and stakeholders from other departments (Production, QC, QA...)

    - Ideally experience in the field of pharmaceutical production (USP development, clinical and commercial)

    - Training in Operational Excellence (LEAN, BELT) a plus

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Andreia Lourenço

  • Randstad Merck Aubonne

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