Manufacturing Development Manager
We are looking for an experienced Manufacturing Development Engineer/Manager with project management experience to establish a Manufacturing Development function at Immudex.
Immudex is a fast-growing biotech company, providing solutions for T-cell immune monitoring. Based on our proprietary Dextramer® technology, we develop and market products, enabling researchers, developers, and clinicians to measure disease-specific immunity.
Your primary responsibilities will be to lead one of our production lines and to plan, run, and secure technology transfer projects from R&D to Production. In addition, you will facilitate optimization of processes and various types of problem solving within Production.
You will work closely with your own team and with colleagues from different departments, build and lead project teams, and execute on timely achievements of targets.
The position will give great opportunities to develop your skills and experiences within planning and execution as well as people management. If you like to make a difference by working with a wide range of stakeholders and get people engaged in technology transfer and process optimizations, you are the person we are looking for.
We expect that you have an academic background within engineering or natural sciences, preferably combined with a PhD within biotechnology, cell biology, or similar and at least 5 years of experience with manufacturing development. Furthermore, we value:
- Experience from a similar position
- Strong and proven project management skills
- In depth knowledge and hands-on experiences of laboratory-related biotechnology methods such as ELISA, SDS PAGE, protein expression, and purification
- Experience in validation of methods and processes
- Excellent analytical, problem solving, planning and organization skills
- Experience and knowledge within GxP manufacturing requirements and documentation practice
- Experience with Lean manufacturing tools
- Good understanding of statistical techniques for data analysis and process understanding
- Fluent in written and spoken English.
You must be able to build strong and high performing teams based upon our core values of trust, commitment, and quality. In addition, we expect you can demonstrate:
- A proven ability to meet targets in a dynamic environment
- Result orientation and pride in timely delivery of milestones
- Ability to set the direction and motivate your colleagues with a positive attitude and team spirit.
Please apply to this position as soon as possible to email@example.com, as we will process applications on an ongoing basis. For more information about the position, please contact Peter Ifversen, Production Director, at +45 6065 0245.
Based in Copenhagen, Denmark, with North American operations based in Fairfax, Virginia, Immudex manufactures MHC Dextramer® for the detection of antigen-specific T cells. Under an agreement with the US Cancer Immunotherapy Consortium (CIC) and the European Cancer Immunotherapy Consortium (CIMT), Immudex also provides MHC Multimer and Elispot proficiency panel services worldwide.
Immudex' MHC Dextramer products are utilized for the quantification or sorting of antigen-specific T cells in life science research, in vitro diagnostics, as well as the development of immunotherapeutics and vaccines. The primary focus is research-use-only products for the immune monitoring of immunotherapy development and monitoring of CMV cellular immunity in transplant and other immune-deficient patients. In Europe, the CE marked Dextramer CMV Kit is approved for in vitro diagnostic use for the quantification of CMV-specific T cells.
USA FDA 510(k) clearance for the CMV kit was granted March 2017. GMP Grade reagents are available.
Our state-of-the-art dCODE Dextramer reagents enable massive multiplexing of antigen-specific T- cell detection. Detection of over 1000 CD8+ T-cell specificities from a single blood sample has been achieved.
Read more at www.immudex.com.