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Senior Production Scientist

Job brief

Immudex is a growing company providing solutions for T cell immune monitoring within immunotherapy, transplantation, infections 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.

At Immudex, we are looking for an experienced and knowledgeable senior production scientist/manufacturing development scientist to be responsible for one of our Dextramer® production lines.

As part of our manufacturing team, you will as Senior Production Scientist, in addition, to be responsible for timely manufacturing of products of one of our Dextramer® product lines, as well implement processes for smooth design transfer of new products and contribute to support customers' needs with flexibility, quality and timely delivery. You will proactively contribute to streamline and adapt processes to meet the increasing product demand and work in alignment with our Quality System to ensure compliance with applicable rules and procedures.

Responsibilities

  • Professionally handle the manufacturing work processes including, but not limited to, assembling folded MHC Dextramer® reagents, and conjugating chromophores and feature barcode oligo sequences
  • Devise and execute efficient manufacturing of current and future products
  • Secure day-to-day production and planning. Develop and apply new and existing continuous process technologies to enable development and support transfer of safe and scalable processes to manufacturing
  • Work proactively with team to optimize manufacturing 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.

Qualifications

  • PhD or Master’s degree within immunology, biology, biotechnology, biochemistry or equivalent relevant education
  • In-depth knowledge with laboratory-related biotechnology methods such as ELISA, SDS PAGE, protein expression, purification and flow cytometry
  • Excellent analytical, problem-solving, planning and organization skills. Proven ability to work under pressure and with changing priorities
  • 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 and 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 the application of statistical techniques for data analysis and process understanding.
  • Project management skills are desirable
  • Proficiency in MS Office and familiar with NAV Dynamic. English proficiency (understands, reads and speaks English) at a high level.

More information

The position is open for immediate recruitment. Please apply to this position as soon as possible to job@immudex.com. Applications will be processed on an ongoing basis. For more information, please contact Peter Ifversen, production Director, at +45 6065 0245.

About Immudex

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. www.immudex.com.

Closed for applications Gem job

Arbejdssted

Copenhagen

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