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  • Location

    Amsterdam

  • Job title:

    Sr. Technician

  • Sector:

    Biotechnology

  • Job ref:

    46785

  • Start Date:

    2021-11-01

Sr. Technician
Company: Multinational Biotech Company
Location: Amsterdam
Start: November 2021


Our client is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so of each of their function 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 department Manufacturing 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 are supporting 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 limited supervision this individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities. This position is located in Amsterdam, the Netherlands and reports to the MFG Manager

Key result areas (major duties, accountabilities and responsibilities)

Independently perform manufacturing of their therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements. This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps.

Responsibilities include

  • Attend/run daily morning meetings
  • Perform weekly/monthly walkthroughs
  • Maintaining orderliness of process area and stocking production area with supplies
  • Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
  • Demonstrating general knowledge of aseptic technics
  • Troubleshoot and resolve process related issues
  • Create work requests as needed
  • Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
  • Assist supervisor/engineer/facilities with investigations
  • Execution of critical and routine and non-routine production operations
  • Informing management of events impacting schedule
  • Perform Batch Production Record, Solution records, Log Book and Forms
  • Enter data into appropriate systems
  • Record data into log books and review log books in timely manner
  • Review manufacturing documentation real time to ensure compliance
  • Coordinate sample preparation and testing
  • Propose and review document revisions and revise when needed including writing of new documents (SOP/BPR/SLR)
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Participate in troubleshooting and document Quality Indicator investigations
  • Interact with the Quality Control department for the planning of analytical samples and monitoring activities
  • Contributes to keeping the GMP documents up to date and thinks about ways and means of improvements
  • 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
  • Participate in troubleshooting and document Quality Indicator investigations
  • Interact with the Quality Control department for the planning of analytical samples and monitoring activities

This individual will manage equipment and support facility related projects by

  • Initiating and following up with work requests
  • Act as subject matter expert for improvement projects
  • Perform scheduled cleaning of equipment
  • Assembly and disassembly of process equipment
  • Perform standardization of equipment
  • Perform product change over activities
  • Execution of equipment and process qualifications and validation

Working with supervision this individual will

  • Provide technical and OJT training for area personnel
  • Provide input on training material development
  • Meet and maintain training requirements
  • Develop and maintain personal development plan
  • Provide annual performance self-assessment
  • Help identify training needs

 

Qualifications

  • Normally requires a high school diploma and at least 5 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with at least 3 years of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field with at least 3 years of cGMP experience
  • 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
  • Hands-on experience in writing and reviewing documentation
  • Experience in (bio)-manufacturing unit operations (USP and DSP)
  • Experience in fill & finish preferred
  • Good writing and oral communication skills
  • Applies experience and skills to complete assigned work within own area of expertise
  • Works within standard operating procedures and/or scientific methods

Core competencies

  • Process-oriented way of thinking and working
  • Detail oriented
  • Self-organized
  • Able to communicate in professional way on diverse levels and channels
  • Capable of taking initiative when necessary
  • Flexible attitude in a challenging environment
  • Intrinsically motivated

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

s.vanderkleij@sire-search.com
+31206589800