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Business Unit Manager Drug Substance Biologics

Eurofins Amatsigroup is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).

Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs:

• Drug substance biological process and analytical method development and production, including GMP manufacturing. The principal technological expertise is production and purification of recombinant proteins derived from microbial and eukaryotic systems, for research purposes and toxicological studies as well as for clinical trials, including formulation development and stress stability studies. The company also has extensive expertise in the manufacturing of viruses and living cells for vaccine purposes and in-depth knowledge of working under pharmaceutical and GMP quality requirements.
• Drug product development of new drug candidates focusing on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and GMP manufacturing of chemical and biologicals drug candidates.

Eurofins Amatsigroup NV develops and produces non-sterile and sterile biologicals (drug substance and drug product) and chemicals (drug product) in preclinical and early clinical development phases.

With approximately 300 staff worldwide, we operate out of 6 sites either in France and Belgium. To support our ambitious growth plan, we are today looking for a Business Unit Manager Drug Substance Biologics for our site in Ghent, Belgium.

Position: Business Unit Manager Drug Substance Biologics

Function description

The Business Unit Manager Drug Substance Biologics will report to the Eurofins Amatsigroup Site Head in Ghent and will interact with all levels across the company. The Business Unit Manager is responsible for early-stage drug substance development projects for the different clients biologics portfolio, e.g. CHO- and microbial-proteins, enzymes, vaccines … The candidate will provide strategic direction, technical expertise, M&A support and tactical oversight for all activities in the area of biologics drug substance development.

Your main responsibilities are:
• You will build and lead the biologics drug substance development group and are responsible for manufacturing process development of drug substance (USP & DSP), analytical development and characterization.
• Provide support to project teams and participate in strategies for product development.
• Responsible for technology transfer for process scale up and manufacture.
• Support the Eurofins M&A group within the field of drug substance biologics
• The candidate will build a sustainable high-performance team fostering an environment of innovation, collaboration, continuous improvement and people engagement.
• You will support the Technical Business Manager in setting up quotations for clients.
• You are a member of the Ghent site management team.

Competences and education:
• A Ph.D. is preferred in pharmaceutical, chemical, biological sciences or engineering, with at least 15 years of experience with biologics, including 5 years in a leadership position.
• Must have strong technical and leadership experience in biologic drug substance development and GMP manufacturing.
• General knowledge across disciplines affecting protein therapeutics (e.g., upstream, downstream, analytical, manufacturing, etc.) is a must. Experience in characterization of a variety of biologics and in design and execution of effect of variable studies (factorial design) to identify process boundaries and critical process parameters.
• Candidate should be proficient in quality and regulatory requirements of biologics products and experienced in early stage development.
• Strong scientific, strategic, creative and tactical skills with the ability to translate strategy into practical plans.
• Good oral and written communication skills, with the ability to communicate effectively and collaboratively with scientific and project management staff.
• Knowledge of Drug Product development is an asset.

We offer you:
• A position with responsibility within a dynamic company
• Working in an innovative and international environment together with a dynamic team.
• Professional and personal development is supported.
• Sustainable and meaningful approach in everything we do.
• A salary, depending on your experience, based on market practice.
• Competitive bonus plan.
• Company car.

Thank you for applying for a career at Eurofins Amatsigroup
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Thank you for applying for a career at Amatsigroup
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