USP Development Team Lead

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. Iceland
Reykjavík
Posting date: 09 May 2019
SC.OB.23184_1557421114

A speciality biopharmaceutical company is currently recruiting a USP Development Team Lead to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

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 Responsibilities:

  • Write/review/approve appropriate written procedures, technical documents, reports, and other cGMP documentations.
  • Support technology transfer with manufacturing (internal and external), scale up/down, troubleshooting, and regulatory submissions.
  • 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.
  • Responsible for leading and coordinating the development team activities in a safe and EHS/regulatory compliant manner.
  • Responsible for keeping the USP team engaged, motivated, and enabled to achieve the upstream development planning.
  • Ensure USP development labs and equipment are maintained in orderly fashion.

Skills and Requirements:

  • Degree in life science, biotechnology or related subject.
  • 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.
  • Experience with screening experiments (Ambr or comparable).
  • Experience applying QbD (quality by design) and DoE approach to develop and trouble shoot development activities..
  • Experience in harvesting techniques.
  • Experience in process characterization, process validation.
  • Understanding of scale up/scale down.
  • Understanding of statistical methods and implementation.
  • Experience with statistical program.
  • Demonstrable experience in a similar or relevant role.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-OB1

#Scientific

close