The Business Unit Manager Drug Substance Biologics will report to the Managing Director of Eurofins Amatsigroup NV 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 (DS team) and are responsible for manufacturing process development of drug substance (USP & DSP).
You will interact closely with the analytical development team that provide services to the DS team.
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.
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.