Overview:
Be part of the biosimilars development group supporting the activities and ancillary tasks of the R&D department.
Perform trials in accordance and in compliance with GLP, GMPs and SOPs.
Responsibilities:
- Maintenance and drafting of standard working procedures and technical documentation that apply to the entire R&D department.
- Responsible for organizing the daily activities of the auxiliary laboratory.
- Supporting the auxiliary activities of the R&D department.
- Execution of scheduled activities and tasks.
o Covering work reports and laboratory notebooks.
o Temperature recording.
o R&D SOP management.
o Storage and management of samples.
- Elaboration and monitoring of training plans and profiles (trainings and readings) in the R&D department.
- Working according to good laboratory practices.
- Ordering reagents and consumables when required, using the assigned commodity specification procedure.
- Continuous improvement - supporting process improvements throughout the Development process.
- Education: Intermediate level studies in any area related to biology, chemistry or biochemistry.
- Languages: Fluent Spanish and basic English.
- Experience (years/area): +2 year experience in laboratory activities.
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Specific Knowledge:
- Knowledge in laboratory equipment.
- Knowledge of GMP standards, as well as FDA/ICH guidelines and international pharmacopoeias.
- Travels: Not required.
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Personal skills:
- High organizational and control skills.
- Ability to work independently and collaborate with other groups in the research and development organization.