Pharmaceutical Development Technician

Work closely with the Pharmaceutical Development Project Leader in all the project allocated in the team group. Give support, technical and administrative, to the team involved in his\her projects as well to the pilot plant operators.

Work together with the different areas of the company (RA, QA, Production, Clinical, etc.) to fulfil all project goals.

Supervise galenical trials located in the pilot plant and as well the process who may be involved in the industrial area.

Issue SOPs, development reports, product specifications and all documentation related to R&D department

Responsibilities

• Supervise all activities performed in pilot plan and in the industrial area for non-GMP and GMP activities
• Issue galenical trials and GMP MBRs
• Review and check raw materials availability.
• Issue POs (materials, equipment, etc.) thought SAP system
• Coordinate the galenical samples to the analytical team
• Ensure the compliance of GMPs during all the galenical activities.
• Issue Galenical Reports
• Ensure good relationships and collaboration with all the team members involved internally and externally.

Requirements

• Education: University degree in Pharmacy; Master in Galenical/Manufacturing is a plus.
• Languages: Mid level of English and Spanish (speaking & writing). Any other language is a plus
• Experience (years/area): At least 2 years of experience in a position of pharmaceutical development technician in oral solids products. Knowledge and expertise of CMC section for ANDAs/NDAs and EMA submissions is a plus.
• Specific Knowledge: Pharmaceutical Development, Fluid Bed Technology, Tech transfer, process development.