Collins McNicholas

 

JOB TITLE:  

USP Development Scientist (Level III)

COMPANY:

Global Biologics Company

LOCATION:

Nordics

OVERVIEW

The Upstream Process Development team are responsible for the end-to-end development of processes from the early use process development right through to technical transfers to manufacturing. This department works in teams of scientists and develop from 2L scale up to 10L scale carrying out screening experiments to characterize the process from shake flask to production bioreactor and then to harvest.

 

JOB DESCRIPTION 

As a level 3 scientist in upstream process development, you will be fulfilling a senior role in a team of scientist 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, but not limited to, solution/media preparation, bioreactor assembly and performing bioreactor experiments.

 

Furthermore, you will 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

 

  • Execute / oversee experiments in an accurate way, ensure data capture is accurate and complete
  • Ensure accurate and complete documentation of lab activities, write appropriate technical development plans and reports.
  • Evaluate cell culture performance, process in- and outputs and product quality attributes in labscale 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.
  • Write/review/approve appropriate written procedures, technical documents, reports and other cGMP documentations.
  • Provide technical, scientific leadership and guidance to the USP development team to ensure efficient development and characterization of an upstream process.
  • Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required.
  • Maintaining leading-edge knowledge and understanding of new technologies in the field of USP process development and proactively share knowledge with the team.
  • Willing to participate in a rotation schedule for weekend work.

  

Competencies required to fulfil the employee responsibilities and work assignments:

  • An employee shall follow the job description that pertains to his/her position. In addition, an employee shall follow the SOPs that pertains to his/her position.
  • An employee shall adhere to the company etiquette in all matters of behaviour and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
  • It is important that an employee has the company values at heart in his/her work.
  • An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her

 

 

EDUCATION AND EXPERIENCE

  • Life Sciences Degree
  • Minimum of 5 years’ experience in biopharmaceuticals or technical field desired.
  • Knowledge of upstream development activities (lab scale (=must) 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
  • Understanding of statistical methods and implementation is a plus
  • Experience with statistical program is a plus

 

Additional Skills and Experience: 

  • Enjoy hands-on work
  • Flexible and can work accurately, both in a team and individually
  • Pro-active, problem solving attitude.
  • Get your thoughts, ideas and knowledge across in a constructive way.
  • Planning and organization skills allow you to keep an overview of the necessary work and you can meet deadlines.
  • Strong verbal and written communication skills to communicate effectively within the department and to other departments.
  • Works in an active, collaborative, constructive and respectfully manner with all colleagues within and across departments.
  • Demonstrated ability to work with flexibility in a changing and demanding environment

 

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