Connecting...

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9uzxh0lxboyxnllxjly3j1axrtzw50l2pwzy9iyw5uzxitzgvmyxvsdc5qcgcixv0

Principal Upstream Development Scientist

Principal Upstream Development Scientist

Job Title: Principal Upstream Development Scientist
Contract Type: Permanent
Location: Reykjavik
Industry:
Salary: TBD on application plus excellent benefits
Start Date: 2019-08-06
Reference: 16323 AB
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: August 07, 2019 15:55

Job Description

An exciting opportunity has arisen for a Principal Upstream Development Scientist. The company manufacture biosimilar monoclonal antibodies at their state-of-the-art facilities in Reykjavik, Iceland.  This company is well resourced and financed with significant growth plans. Their manufacturing process is based on 1,000L and 2,000L single use bioreactor fermentation design and has a total capacity of 16,000L and is run almost totally on renewable energy.  
 
As a level 3 scientist in upstream process development, you will be fulfilling a senior role in a team of scientists that is responsible for the development of bioreactor processes and subsequent scale-up and transfer to a manufacturing environment. Your activities will consist of lab support tasks, including; solution/media preparation, bioreactor assembly and performing bioreactor experiments.  You will also be responsible for execution (or overseeing) of experiments in all USP unit operations (SF, Ambr, rocker, bioreactors and harvest), including data collection, analysis and reporting.
 
Job Responsibilities:
  • Evaluate cell culture performance, process in- and outputs and product quality attributes in lab scale bioreactors
  • Optimize bioreactor conditions regarding cell culture performance, process controls and product quality attributes
  • Ensure accurate and complete documentation of lab activities, write appropriate technical development plans and reports
  • Write plans, reports for screening studies and process characterization studies for all USP unit operations
  • Author, amend and review operating documents, such as SOPs and batch records
  • Contributes to ensure the USP development suite and equipment is maintained in an orderly fashion
  • As a SME (subject matter expert), contribute to successful commercial Pre-Approval Inspections, regular audits and others as required 
Qualifications:
  • Knowledge of upstream development activities (lab scale and production scale) including hands-on expertise operating upstream equipment
  • Experience with fed-batch and perfusion mode
  • Knowledge of QbD (quality by design) and DoE approach to develop and trouble shoot development activities
  • Knowledge of process characterization, process validation
  • Understanding of scale up / scale down
Please forward your CV to Alex Butcher or phone 01403 216216 where we would be happy to tell you more about this exciting Senior Upstream Development opportunity.