Bioassay Technical Specialist

About PSC Biotech

• We are hiring a Bioassy Technical Specialist.
  
• This is a position requiring someone with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories. The successful candidate will be responsible for leading the effective and efficient running of Analytical Bioassay and ELISA methodologies both globally and locally Analytical Method Transfers Validations Investigations and Change Control. In addition the successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytical Sciences group.
  
• The successful candidate will demonstrate a high level of technical leadership collaboration coaching and mentoring to facilitate the team in becoming a high performing organisation and ensuring timely delivery of projects. Central to this objective will be the active engagement and communication with all internal and external stakeholders. A high level of innovation enthusiasm and drive will also be required to deliver technical excellence for analytical methods.
  

Requirements

What you will do:

• Good knowledge of working practices required for working in a Bioassay laboratory (e.g. ELISA cell biology cell culture protein biochemistry etc.)
  
• Support assay optimisation/investigations within the Bioassay area
  
• Analytical Technology Transfer
  
• Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  
• Lead the delivery of projects whilst adhering to project timelines using project management tools.
  
• Lead crossfunctional problemsolving teams for troubleshooting and investigations within local Quality other Sites within the network and contract laboratories as required.
  
• Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and lifecycle management of Bioassays.
  
• Engage in ongoing Bioassay performance monitoring.
  
• Prepare review and approval of technical documents procedures CAPAs change control deviations metrics etc.
  
• Actively pursue development opportunities to increase the skill set and experience within the group through continuous education job rotation crossfunctional training Lean Six Sigma etc
  
• Collaborate with internal partners (i.e. other sites R&D) and externally with CROs
  

What skills you will need:

• BSc in a relevant Science discipline
  
• Experience with ELISA/ Bioassays and leading analytical method validations
  
• Selfmotivated and ability to work as part of a team with good project management skills
  
• High level written and verbal communications with advanced PC skills
  
• Knowledge and experience of operating in a development and commercial lab environment
  
• Project management or qualifications such as Project Management Professional (PMP)
  

Desired Qualifications/Experience:

• Ph.D./M.Sc. qualification (Science)
  
• Knowledge of and experience in applying Six Sigma and Lean methodologies
  
• Equipment commissioning and qualification.
  

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