Scientific director in formulation and tablet manufacturing
ZERION is a pharmaceutical company enabling the development of novel drug products by improving the solubility and bioavailability of small molecule drugs. We aim to bring our first drug formulation to the market within 4-5 years and obtain regulatory acceptance of our whey protein as a novel pharmaceutical excipient. This is an ambitious plan, but we want to challenge the established pharma industry and show that this is possible. We are now moving into upscaling of our unique Dispersome® formulation technology aiming at producing GMP material at a CDMO for our first clinical trial. Therefore, we need an experienced formulation scientist with leadership skills who can take the lead on the development of our Dispersome® formulations into final dosage forms, i.e. capsules or tablets.
You will be the scientific lead of our R&D department and responsible for formulation development of solid oral dosage forms for different Dispersome® formulations and preparing these for GMP manufacture. This includes – without limitation – responsibility for:
- Development of solid oral dosage forms for amorphous Dispersome® formulations. Including the identification of the tablet composition, choice of excipients, as well as the necessary process steps such as blending, granulation, compaction, coating etc.
- Assessment and quality control of solid dosage forms according to Ph.Eur and USP.
- Strategic planning of formulation development and coordination of laboratory activities with our formulation team
- Definition of critical process and quality parameters and design of process validation protocols.
- Contribute to establishing full manufacturing processes for final products - in close collaboration with our CMC department and CDMOs.
- Design of project plans and protocols with internal and external stakeholders, including CDMOs.
- Technical reports and updates to the ZERION executive management.
We are seeking a self-motivated and independent person, with a PhD degree in pharmacy, chemical engineering, or similar; and 5+ years of experience from working in the industry. You should have experience from working with the downstream processing of solid oral dosage forms in pharmaceutical manufacturing of tablets and/or capsules.
You have experience with all or most of the following areas:
- Formulation and manufacturing of oral solid dosage forms and final dosage preparation, by unit operations such as blending, granulation, tableting, coating, etc.
- Expert knowledge of solid state characterization and analytical methodology as part of drug product characterization.
- Interpretation of in vivo pharmacokinetic data to guide formulation research and development.
- Preparation of amorphous drug delivery systems for small molecule drugs including down-streaming processes, i.e. spray drying, roller compaction and tableting
- Transfer of lab processes to pilot scale and full-scale manufacturing (solid oral dosage forms).
We expect that you aim at meeting high-quality standards in your work, dedicated to meet deadlines critical to the team and the company.
You will be working closely with the dedicated and innovative colleagues from the R&D and CMC departments at ZERION. We offer a challenging job in an exciting environment where you will be an essential part contributing to our ambitious goal of bringing our novel amorphous formulation technology from our research lab to industrial manufacturing and the market.
ZERION has offices/lab facilities at KU Campus and in Birkerød.
- Please submit your application and CV to ZERION ApS, Blokken 11, 3460 Birkerød or by e-mail to email@example.com, attention Korbinian Löbmann before September 30, 2020.
- If you want to hear more about the position, please contact Korbinian Löbmann, CSO at +45 53 14 55 16