Downstream Process Manager
Downstream Process Manager
Industriepark-Zwijnaarde 7B, Ghent, Belgium
Eurofins CDMO wishes to enforce its biological purification team with a Downstream Process Manager and is looking for a professional with a strong background in manufacturing (recombinant) proteins for medical applications. Experience in the biotech sector and with the downstream process in development and (GMP) manufacturing of proteins is essential.
We are looking for a person that collaborates with the Eurofins CDMO team in expanding the growth of the company. He/she will report to the Business unit manager of DS Biologicals.
His/her main responsibilities are:
Establish and lead the downstream group within the Biological Drug Substance Unit with process and operations-based expertise to support delivery (on time and within the budget) of developed purification processes and of clinical batches of purified recombinant proteins.
Be responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for GMP production.
Interact with other departments within the company (from business development to other teams involved in the progress of the productions).
Preparation and revision of downstream purification batch records and reports.
Lead initiatives to ensure continuous improvement of the tools and technologies that are used for downstream processing in our company.
Lead initiatives to ensure optimal planning and communication to the appropriate stakeholders and project managers.
Introduce innovative technologies within the DSP department and follow the latest trends for innovative biotech products.
Mentor junior scientists or associates, providing scientific and technical expertise and guidance on downstream processing.
Present results at internal and external meetings (scientific and with clients).
Represent the downstream group at regulatory inspections (during audits).
A PhD or a Master Degree with scientific orientation (Pharmaceutical Sciences, Chemistry, Biochemistry, Bio-engineering, Industrial Engineering) or related discipline with relevant expertise, e.g. downstream processing of recombinant proteins on a microbial and/or mammalian platform.
Experience in technology transfer, purification process development and transfer to GMP.
Experience from lab scale to large scale manufacturing.
Knowledge of process characterization and validation.
Should have knowledge of cGMP and quality system.
Ability to proactively address process-related issues.
Excellent organization, flexible and coordination skills.
Excellent oral communication, reporting and presentation skills.
Ability to work independently as well as a member of a team in a dynamic environment.
Skilled in training, coaching, leading people.
Fluent in English written and spoken. Knowledge of Dutch is an asset.
Work in a fast-growing organization.
A position with responsibility within a dynamic company.
Personal development through learning on the job and additional external training.
A market-oriented compensation.
Please send us your application: https://jobs.smartrecruiters.com/Eurofins/743999783918284-downstream-process-manager