Scientist Drug Product Development
Start: ASAP (aimed for 1st of March 2021)
Looking for: PhD with +/- 3 years of relevant working experience in a comparable position, preferably in an industrial organization
The company is working on the hottest topic of modern biology at this moment: gene therapy, which has the potential to change millions of lives worldwide.
Gene Therapy uses genes to treat diseases by deleting, adding or altering DNA. It targets the root cause of the problem instead of just treating the symptoms and is a truly personalized medicine.
Scope of the role
Our client's gene therapeutic vectors are complex biological products that are subject to extensive quality testing before they are release for purpose. The Scientist Drug Product Development (DPD) is responsible for development activities pertaining to the company's gene therapy drug products throughout their lifecycle. Overall, the Scientist DPD will play an important role in implementing the formulation platform and increase understanding of the physicochemical attributes of its new gene therapy products, from the preclinical development phase up to market authorization.
- Design (DoE), plan, supervise and report formulation, stability, characterization, and compatibility studies (includes hands-on time)
- Timely and adequate writing of study protocols and reporting of study results
- Support Process Development, Analytical Development and Manufacturing on Drug Product related topics (e.g. physicochemical characterization, new formulation implementation, evaluation of stability-indicating product quality attributes, early/supportive evaluation of product stability) throughout product lifecycle
- Support Non-Clinical and Clinical Development on compatibility topics (e.g. diluent, plasma, device compatibility studies)
- Contribute to regulatory submissions (IMPD, IND, dossier variations)
- Explore and establish novel analytical methodologies to characterize the product from a physicochemical viewpoint.
- Participate in generating intellectual property
- A PhD in a Life sciences-related field with affinity for analytics (HPLC, spectrophotometry, molecular biology...) or proven equivalent industry experience.
- Proven scientific or technological background (publications, specific experience)
- Affinity with hands-on work (i.e. willingness to work in the laboratory)
- Affinity with physicochemical characterization of biologics preferably recombinant viruses
- Understanding of Process Development of biological products
- Knowledge of regulatory policies and guidelines regarding stability (ICH, compendia (Ph. Eur., USP))
- Familiarity with Good Manufacturing Practices in the biotechnological or pharmaceutical industry
- 2 years of relevant working experience in a comparable position, preferably in an industrial organization
- Integer: accurate, dependable, proactive
- Detail oriented with strong analytical skills, strong affinity with (and keen interest in) raw analytical data are a prerequisite
- Planning and organizing: able to plan multiple ongoing studies simultaneously.
- Taking initiative: signals problems, recognizes important information, traces possible causes of problems, thinks about and implements new working methods or new applications, brings forward original solutions for problems related to the department and function.
- Cooperative: ability and drive to work in interdisciplinary (project) teams; strong communication skills
Are you interested in this position or do you want to know more about it? Do not hesitate to contact me by applying to this position!