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Product Design and Process Development Manager

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Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please visit www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

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Product Design and Process Development Manager

Responsibilities :

As Product Design & Process Development Manager, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, production of non GMP batches. You ensure the work is performed in compliance with Quality corporate policies.
You report directly to the CEO and are part of the Executive management.

Your main responsibilities include:

  • Lead the overall management of product and process development.
  • Manage the non-GMP productions.
  • Manage all drug substance and drug product activities of technology transfer to GMP unit.
  • Identify, select and oversight subcontractor for process optimization, non-GMP manufacture of Drug Substance (API) and Drug Product (DP).
  • Deliver robust, scalable, industrialisable and cost-effective manufacturing routes.
  • Ensure the compliance of all CMO with relevant regulatory standards.
  • Define and execute plans for API and DP validation and registration, in coordination with QA and RA.
  • Supports, informs and aligns with cross functional project management team members such as preclinical development, QC, QA, RA units.
Profile :
  • Master degree or PhD in science, bioengineering or related.
  • At least 5 years relevant experience in a pharmaceutical or biotech environment.
  • Relevant expertise in lab techniques focused on protein purification and analysis..
  • Thorough knowledge of relevant FDA and EMEA regulations is an asset.
  • Experience with implementing technical, strategic and operational plans.
  • Excellent communication and organizational skills.
  • Ability to identify and resolve critical issues.
  • Fluency in French and English.
Offer :
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.
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