Manufacturing Development Manager

Manufacturing Development Manager

An exciting and challenging job as manager of our Manufacturing Development unit is open for a protein scientist/engineer with experience in upscaling and optimization of small-scale downstream & upstream processes.

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.

 

Job Brief

You will be leading our new Manufacturing Development unit and be in close contact with our R&D, QC, and Production departments. You will report to the Production Director. Location: Virum, Denmark.
You will work cross-functionally with colleagues from other departments and your own growing team while securing project milestones are executed timely. Knowledge of expression and purification of proteins, such as MHC molecules, will be a strong asset.
Your primary tasks will be to:

  • Secure technology transfer projects from R&D to production
  • Provide hands-on manufacturing engineering knowledge for processes optimization and upscaling within production
  • Facilitate various types of problem solving in production.

 

Technical Qualifications

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
  • In-depth knowledge of laboratory related biotechnology methods for small scale protein expression and purification, preferentially FPLC
  • 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
  • Leadership skills
  • Good understanding of statistical techniques for data analysis and process understanding
  • Fluent in written and spoken English.

 

About You

You must be able to build strong and high performing teams based upon our core values of trust, commitment, and quality. Therefore, we expect you can demonstrate:

  • A proven ability to work under pressure and 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.

 

We Offer

Immudex offers a dynamic workplace in a fast-growing company where we have an informal work environment characterized by dedicated employees with a desire to make a difference.
We process applications on a continuous basis which is why we encourage you to send your application and CV as soon as possible to job@immudex.com

If you have any questions about the position, please contact:
Production Director, pi@immudex.com, mob. +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 dCODE Dextramer reagents enable massive multiplexing of antigen-specific Tcell
detection. Detection of over 1000 CD8+ T-cell specificities from a single blood sample has
been achieved.

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Contact Immudex

General Inquiries
Email: info@immudex.com
Main: +45 31 10 91 91
Fax: +45 77 31 15 09
CVR/VAT no. 31348854

Ordering
Email: ordering@immudex.com
Ordering: +45 29 13 42 24

Technical Support
Email: customer@immudex.com