QC Team Leader
Immudex is a fast-growing biotech company providing solutions for T-cell immune monitoring within immunotherapy, transplantation, infectious disease and autoimmunity. Based on our proprietary Dextramer technology, we develop and market research reagents and diagnostic assays enabling researchers, developers, and clinicians to measure disease-specific T cell responses.
We are looking for an experienced and knowledgeable QC scientist to implement new and optimize existing QC assays and to lead our QC technician team.
The team performs daily QC testing of intermediate and finished products in close collaboration with the production unit. In addition to leading the team, you will perform transfer and validation of new assays from R&D, process optimization, stability studies and troubleshooting in close collaboration with other departments.
You will contribute to streamline and adapt processes proactively to meet the increasing product demand and work in alignment with our Quality System to ensure compliance with applicable rules and procedures.
- Secure daily QC testing of intermediates and finished products in alignment with the production unit
- Daily scientific management, analysis and reporting of test results
- Optimize relevant assays as well as assuring that QC equipment is maintained and calibrated timely
- Support transfer of safe and scalable processes on new products to the QC team
- Work proactively with team to optimize QC processes and perform problem-solving
- Ensure procedures are implemented in an optimal and timely manner
- Fulfil customer needs in a timely manner with high quality products
- Ph.d. or master’s degree within immunology, biology, biotechnology, biochemistry, or equivalent, relevant education
- In depth knowledge with laboratory-related biotechnology methods such as flow cytometry, ELISA, and SDS PAGE
- Excellent analytical, problem-solving, planning, and organizational skills
- Experienced in validation of new methods/techniques (assays)/processes
- Strong organizational skills and ability to prioritize workload in order to meet tight deadlines in a fast-paced and dynamic work environment
- Experienced and knowledgeable within GMP or ISO 13485 manufacturing requirements, and documentation practice
- Self-motivated and time efficient, structured and pragmatic with a proactive and quality-oriented mindset
- Good understanding of application of statistical techniques for data analysis and process understanding
- English proficiency (understands, reads and speaks English) at a high level
- Pleasant personality, trustworthy and a positive attitude
If the above sounds tempting, do not hesitate to send us an application.
Please apply to this position as soon as possible, and no later than June 2, 2020 to email@example.com. For more information, 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 dCODETM 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.