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Jr. Technician Biotech

Company: Multinational Biotech company
Location: Amsterdam
Start: November 2021 (preferably ASAP)

Our client is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so, each function in the organization is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
 

The Manufacturing department has an important role regarding the quantity and quality of our AAV-based products. cGMP is applied to manufacture and verify the quality of our products to ensure (i) proper delivery and functionality as well as (ii) safety. Those activities support the whole scope of AAV product and process development. By strict application of cGMP guidelines, monitoring, and qualification of our manufacturing environment and systems, the manufacturing of drug substance and drug product is performed.

Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, QC, QA, Engineering and Validation.

With direct supervision this individual will perform routine manufacturing operations for the production of clinical and/or commercial products. Operates production equipment according to SOPs in their assigned areas. This position is located in Amsterdam, the Netherlands and reports to the MFG Manager

Key result areas (major duties, accountabilities and responsibilities)

Perform manufacturing therapeutic products and ensure this is realized and documented according to the highest industrial and cGMP quality requirements

The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records (BPR) and Solution records (SLR). Primary responsibilities include

  • Execution of routine production operations
  • Attend daily morning meeting
  • Perform weekly/monthly walkthroughs and generate work requests if necessary
  • Maintaining orderliness of process area and stocking production area with supplies
  • Demonstrating general knowledge of aseptic technics
  • Perform Batch Production Record and Solution Prep records
  • Enter data into appropriate systems
  • Maintain Kanban room and assist with supply chain to re-stock materials
  • Record data into log books
  • Sample preparation and testing
  • Propose document revisions
  • Complete required training on time
  • Carry out work in a safe manner, notifying management of safety issues and risks

This individual will manage equipment and support facility related projects by

  • Perform scheduled cleaning of equipment and clean room
  • Perform standardization of equipment
  • Support product change over activities and submit non-routine cleaning requests
  • Assist in the assembly and disassembly of process equipment

Staff Technical Training and Development

  • Meet and maintain training requirements
  • Develop and maintain personal development plan
  • Provide annual performance self-assessment on development plan
  • Keep the manufacturing plant, labs and activities up-to-date in order to meet our client's needs in terms of planning, quality, safety, health and environment

Qualifications

  • Normally requires a high school diploma and 0-2 years related industry experience or an Associates Degree in Life Sciences/Engineering field. Biotech Certificate preferred
  • Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
  • Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures
  • Applies experience and skills to complete assigned work within own area of expertise
  • Works within standard operating procedures and/or scientific methods

Core competencies

  • Has a process-oriented way of thinking and working
  • Is detail oriented
  • Has a flexible attitude in a challenging environment
  • Is eager to learn

Interested?

If you are interested in this position please apply! Might you have any additional questions or remarks concerning this vacancy do not hesitate to contact me then!

Stijn van der Kleij

s.vanderkleij@sire-search.com
+31206589800

 

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804