Lead Scientist USP
HALIX B.V. - Leiden (Nederland)
For our client, HALIX B.V., we are looking for a Lead Scientist USP.
In this role, you will oversee up to 3 projects (USP part) of various complexity, take tactical and operational decisions and work with your team and clients, to make these projects a success.
To do so, you will interact with their clients on a regular basis to translate requests into work packages, experiments or actions, co-ordinating the work internally and update on progress of the USP development.
Secondly, you ensure development of reliable and robust USP processes at the target scale for GMP manufacturing, Thirdly, you will provide information and input for tech transfer to GMP manufacturing, for process validation runs and trouble shooting in GMP.
And finally, you will help expanding capabilities by scientific training and introduce state-of-the-art USP techniques for future clients.
Tasks and responsibilities:
- Provide advice and scientific input to business development and future customers, to scope new (subsections) of projects and translate to internal resource requirements and timelines;
- Organise and provide technical updates to clients and internal stake holders on status of USP project activities;
- Co-ordinate and co-execute transfer and installation of client process in our development lab;
- Discuss project risks with internal stake holders (multidisciplinary) and clients and propose effective mitigations;
- Monitor timelines and quality of experiments and take decisions to drive project progress;
- Execute, set-up, or provide advice on effective experiments (QbD if required) to a small team of Associates and Scientists in process- and analytical development;
- Write or review development protocols, draft-SOP's, development Batch Records and reports to ensure consistent quality and reliable data and information (e.g. ALCOA+);
- Assist in / execute systematic trouble shooting of issues with the process to prevent reoccurring (e.g. poka yoke, templates, training, checklists);
- Give input to process transfer to GMP manufacturing and define/give project specific training to operators, provide input and co-ordinate Process Validation runs;
- Initiate and execute general process improvements to improve safety/lead time/efficiency (across departments);
- Train USP Associates and USP Scientists depending on the job or contribute to internal knowledge sharing initiatives;
- Identify opportunities for capability expansion: new developments w.r.t. USP equipment or relevant scientific trends or breakthroughs to remain state-of-the-art.
Who we're looking for
The ideal candidate has a Master or Ph.D. in Biosciences, Biochemistry, Bioprocess Engineering or Biotechnology with at least 12 years of industry experience (mostly development). You have experience with USP development in a bio pharmaceutical production environment, adherent and suspension cell lines, lab scale to 1000L bioreactor preferably single use, production of recombinant proteins, (viral) vaccines and antibodies. Finally, you have experience with external client contact, R&D, project co-ordination, working in BSL-2 facility, tech transfer to manufacturing, cGMP and FDA guidelines, QbD and DoE.
Are you the customer oriented and dynamic team player we are looking for?
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organisation (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialisation of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases.
Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset.
Additional vacancy information
|Contract||:||Direct contract with client|
|Employment terms||:||Salary: 90k|
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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