Consultant USP Development
A speciality biopharmaceutical company is currently recruiting a Consultant USP Development 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.
As a consultant in upstream process development, you will be responsible to provide technical, scientific leadership to the USP development team. The focus is on writing technical documents, writing and reviewing plans and reports, along with implementing a database for USP-development.
- Writing/reviewing/approving technical documents, reports, and other cGMP documentations.
- Writing 10L Scale down model qualification report.
- Writing Control strategy reports for USP unit operations.
- Writing CPP/KPP report for all USP unit operations.
- Critical Material Attributes (CMA) writing for all USP unit operations
- Reviewing reports from scientists
- Setting up a master file for perfusion data
Skills and Requirements:
- Degree in life science, biotechnology, or related subject.
- Minimum of 5 years' experience in biopharmaceuticals.
- Thorough knowledge of upstream development activities (lab scale (=must) and production scale).
- Thorough knowledge and experience with both fed-batch (=must) and perfusion mode USP processes.
- Experience with process validation, including authoring plans, reports, and data analysis.
- Experience QbD (quality by design) and DoE (designing, analysing, reporting).
- Experience scale up/scale down.
- Experience of statistical program (JMP or minitab).
- Experiences with databases is a plus.
- 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.
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 Joshua Dada at +44 203 078 9552 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.
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