Process Engineer – Innocore
InnoCore Pharmaceuticals is a biopharmaceutical drug delivery company located in the City of Groningen. We are the partner of choice for the development of complex long-acting injectable drug delivery products with improved therapeutic efficacy and fewer side effects. We are recognized as a customer-focused centre of excellence with an unsurpassed drive to provide solutions for our rapidly growing international client base of pharmaceutical companies. Our multi-disciplinary team of around 40 experts are specialized in the development of microparticle-, gel- and implant-based injectable sustained-release formulations for the treatment of a variety of chronic diseases. In addition to our highly versatile portfolio of proprietary biodegradable polymeric drug delivery technologies and an extensive track record in pharmaceutical development, we offer cGMP manufacturing of clinical supplies. Due to the success of our innovations, we need to expand our team and we currently have a job opening for a
As a Process Engineer, you are responsible for robust scale-up of manufacturing processes from laboratory scale to a scale suitable to support manufacturing of GLP tox materials and GMP productions. Your responsibilities include (but are not limited to) scaling up of polymeric microsphere manufacturing processes from laboratory scale to GMP production. You work on several projects in parallel, independently and as part of multiple project teams and in close collaboration with InnoCore´s customers.
As a Process Engineer you:
- Plan, prioritize and execute the experimental work related to the scale-up of microsphere process from laboratory to manufacturing scale.
- Take the lead in selection, purchase, installation and qualification activities (IQ/OQ/PQ) of equipment needed for scaling up the manufacturing process.
- Take the lead in transferring the processes to selected CDMOs.
- Provide written and verbal project updates with managers, project sponsors and other stakeholders
regarding project status, risks/issues and accomplishments.
- Find and work with vendors capable of sourcing both off-the-shelf and custom equipment
- Independently operate process equipment, write operation procedures, write batch records, train
the operating team, provide technical supervision, document the outcomes and identify next steps.
- Are skilled in incorporating and executing project activities founded on a Quality by Design
- Support the Scientists Formulation & Process Development in formulation research and development of robust formulations and well-scalable processes.
- Ensure – together with other members of the project teams – that the manufactured products meet
their specifications and are in accordance with the Target Product Profile set with the customer.
- Perform troubleshooting on equipment and processes and initiate corrective actions.
Profile and background
In addition to having a BSc or MSc in Chemical Engineering, Process Engineering, Mechanical Engineering or related discipline, you:
- Have at least – but preferably more than – 3 years of demonstrated experience in process
development in a pharmaceutical environment.
- Have good knowledge of polymer chemistry and formulation science, preferably experience with
- Have experience with upscaling complex manufacturing processes from laboratory to manufacturing scale, preferable microspheres.
- Have experience with aseptic manufacturing
- Have a technical mindset and hands-on mentality.
- Take ownership and are self-organized.
- Are driven by results and you have a strong customer focus.
- Are eager to continuously improve products and processes. You recognize opportunities, recommend changes, and work them towards results.
- Are self-aware, self-critical and open to giving/receiving feedback in a respectful and transparent way.
- Are eager to grow by challenging your own limits of knowledge and experience.
- Have a strong affinity with quality at work and strong awareness of company procedures and GMP/GLP guidelines.
- Have a strong power of analysis, illustrated by the ability to quickly recognize the core issues, trends
- Can effectively transfer knowledge to others. You have strong reporting and verbal communication
skills and are proficient in English.
- Show a strong ‘I care mentality’ by taking on responsibility and showing accountability for HSE risks towards yourself, colleagues and third parties.
We offer a challenging position in a modern and well-equipped laboratory where you will become part of a young and ambitious team of co-workers. Remuneration will be according to standards in the pharmaceutical industry. At InnoCore we are committed to offering the best possible environment for our employees, where people are challenged and supported to further develop themselves. We believe in providing a collaborative, creative environment where each member of the team feels encouraged to contribute to our processes, decisions, planning, and culture.
For more information about this vacancy, contact Managing Partner, Jos Zijlstra +31 6 40000033