About our Client
Our client, Bio-Sourcing, is a leading biotech organization dedicated to developing and producing high-quality therapeutic proteins. They specialize in producing biologicals in milk, with a focus on making them more affordable and accessible. Innovative delivery routes are also a target. As they expand their operations, they are seeking a dynamic and experienced professional to lead their DSP team.
Your role
As the Head of Downstream Processing (DSP), you will play a critical role in ensuring the successful purification of recombinant proteins from milk. Your main goal will be to improve and implement the process to transform the milk into a clarified solution containing the recombinant protein. Your expertise will be essential in maintaining product integrity, scalability, quality, and process economics throughout the entire process. We also expect the valorisation of the milk to promote innovative delivery routes for our biologicals.
Key Responsibilities
Full Purification Process Expertise:
- Lead the development and optimization of downstream purification processes for biologicals from the milk, with a strong preference for experience in monoclonal antibodies (mAbs).
- Collaborate with upstream teams to ensure seamless integration of purification steps.
- Apply your deep understanding of chromatography, filtration, and other purification techniques to ensure the development of a process compatible with the final purification after milk clarification, achieving high yields, activity and purity.
- Utilize the raw milk, milk fractions and/or components (such as exosomes) to develop molecules with innovative delivery routes, such as oral and topical delivery.
Quality and Compliance:
- Leading the development and implementation of relevant analytical tools aligned with R&D needs, Regulatory Affairs and CMC strategies.
- Ensure strict compliance with safety requirements, containment protocols, and standard operating procedures.
Cost-Effective and Scalable Process Development:
- Drive efforts to build a cost-efficient and scalable downstream process.
- Optimize existing purification methods and explore novel approaches to reduce COGs.
- Conduct process economic evaluations, considering raw material costs, consumables, labor, and facility expenses.
Technology Advocacy and Innovation:
- Champion the DSP technology within the organization and externally.
- Engage with stakeholders, including investors and potential partners, to articulate the value proposition of our purification platform.
- Propose new methodologies and technologies that enhance process efficiency and attract funding.
Team Leadership and Collaboration:
- Manage a team of experienced scientists with complimentary background.
- Foster a collaborative environment, promoting knowledge sharing and cross-functional interactions.
- Provide mentorship and guidance to colleagues for successful technology transfers and process development.
Reporting and Communication:
- Author internal reports, regulatory documents, and executive summaries.
- Present functional updates to senior leadership and participate in steering committees.
- Collaborate with external network partners.
Your profile
- Ph.D. or equivalent in a relevant scientific discipline (Biochemistry, Biotechnology, Chemical Engineering, etc.).
- Proven experience in downstream processing, including purification of biologics (especially mAbs), preferentially in the pharma industry and from different matrices, with capability of designing processes.
- Hands-on experience with pilot(large)-scale separation equipment (filtration, centrifugation, chromatography, etc.) into the pharma industry.
- Experience with purification of extracellular vesicles, as exosomes.
- Strong analytical skills, with hands-on experience
- Critical thinking, and problem-solving abilities.
- Strong understanding of protein stability, quality control, and regulatory requirements.
- Excellent leadership, communication, and organizational skills.
Our client's offer
The opportunity to join an innovatice and dynamic company.
Person in charge
Mélodie Dumoulin - Recruitment Consultant
Office : +32 010 39 21 83 / +32 475 63 39 28
Mail : mdumoulin@plusonesearch.be
