Scientist - Quality by Design - Iceland
Naynesh Mistry at CK Science is currently recruiting for a Scientist (Quality by Design) to join a leading Biopharmaceutical company based in Iceland on a permanent basis.
Summary: The ideal candidate will have experience in Quality by Design (QbD), Process Characterisation (of biomolecules) and Design of Experiments (DOE) experience
As a Scientist (Quality by Design) you will:
- Manage the pharmaceutical development aspects of a biosimilar development project as a drug product subject-matter-expert in a cross-functional team, define and track activities, propose timelines and budget.
- Design, plan, perform, interpret and report experiments for the pharmaceutical development of biosimilar pipeline products, specifically leading the development of stable liquid formulations, selection of primary packaging material and raw material qualities, development and characterization of robust manufacturing processes for the filling of syringes and vials according to QbD principles, and production of pre-clinical trial supplies.
- Lead and manage drug product manufacturing process transfers from development to production.
- Support process validation, specifically driving process risk assessments, attending production runs, evaluating large-scale data in close collaboration with production-site team.
- Generate scientific documents, support the generation of international registration documents, support registration activities.
- Support the improvement of QbD development concepts, template and procedures
The successful Scientist (Quality by Design) will have the following qualifications, skills and experiences:
- PhD in pharmacy, biotechnology, biophysics, biochemistry or similar education
- Industry experience in pharmaceutical development or manufacturing of finished dosage forms for biopharmaceuticals.
- Knowledge of GMP, QbD, statistical design of experiments.
- Team player with strong leadership and organizational skills.
If successful you will be joining a leading Biopharmaceutical company based in Iceland with excellent benefits.
To apply for this Scientist (Quality by Design) position contact Naynesh Mistry via email: firstname.lastname@example.org or telephone: 01246 457 703 or please click on the link below.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH33893 in all correspondence.