Job Purpose :
The Specialist - Process Development Purification Technologies is a Biopharma industry-experienced development person specialized in the Downstream field joining a team of experts focusing on Drug Substance (DS) process development for new vaccine candidates from Phase I up to commercial launch, as well as on Life Cycle activities for process improvements in the commercial vaccine portfolio.
The incumbent will report to the Head of Development, within the Cell and Viral Drug Substance (CVDS) department in Belgium, which is part of the Global Drug Substance organization in Technical R&D (TRD).
Your Responsibilities :
You will be expected to lead autonomously the DSP part of several drug substance development projects in parallel, driving the implementation of latest industry trends and state-of-the-art technologies into current manufacturing processes, identifying and promoting opportunities for improvements aiming for scalable, high efficiency, robust, and cost-effective manufacturing processes with reduced-footprint.
You will be expected to have strong project management skills and perform timeline and resource planning estimations, design development strategies, plan experimental protocols, lead horizontally a team of technicians and operators to execute them, having a strong presence in the lab to ensure best practices, compliance with documentation practices and EHS standards.
You will be expected to follow the Quality by Design (QbD) approach to process development, leading multi-disciplinary Technical Risk Assessments and ensuring to meet all documentation deliverables required at each of the project stage gates.
You will be expected to support the Development Unit Head in bringing the team (both in your own development unit as well as in the others across the department) to the next level in technical knowledge and best practices, proactively promoting initiatives.
Most concretely, in implementing automation in chromatography development.
You will ensure a strong interface and knowledge sharing with, Manufacturing Science and Technology, manufacturing strategy, site management, Process Science, and engineering departments for building-related activities such as revamping, scaling-up or tech transfer to new facilities.
You will work very closely with the Scale-up team from the development stages to ensure a smooth transition throughout the scales required at the different project phases.
You will closely collaborate with the In-Process Analytical (IPA) organization to develop IPA strategy and implement IPA testing as a fit for Upstream processes.
You will build strong relationships and a collaborative network with the DS organizations & colleagues in Italy and the US aimed at increasing sharing and learning, better decision making, stimulating people development and pushing top science & technology throughout the network.
You will be expected to write and review project reports including process history files, process development reports, etc.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
PhD in Bioengineering, Biochemistry, Biotechnology, Chemistry or equivalent with 2 3 years’ experience or a Master’s in Bioengineering, Biochemistry, biotechnology, chemistry or equivalent with 4 to 5 years’ experience in Downstream Drug Substance Development and / or Manufacturing (Product and Process Expert) in biopharma / biotech industry.
Thorough understanding of vaccine upstream and downstream development and / or manufacturing, with working knowledge on global CMC regulatory requirements for vaccine products.
Demonstrated expertise in the following is required : chromatography development at small scale in AEX, HIC, MMC, or other / mastering of AKTA Avant / Pure and Unicorn 7 / Tangential flow filtration development / Depth filtration development / Viral clearance / GMP manufacturing / scale-up and scale-down / technology transfer.
Experience and capacity to manage the planning and workload of the Lab Technicians will be a key element of this role.
This includes coaching, mentoring & aligning. When necessary, possibly give input as to their development.
Deep understanding of Quality by Design approach and deliverables.
Sound scientific methodology, critical thinking and problem-solving skills.
Strong communication skills.
Demonstrated ability to be proactive, take initiative, and lead autonomously.
Fluent in English. French and / or other languages a plus.
Preferred Qualifications :
If you have the following characteristics it would be a plus :
Expertise in High throughput development / HTPD plates / Robocolumns / Design of Experiments (DoE).
Ideally 3 5 years or more experience in Vaccines Drug Substance development and / or manufacturing (Product & Process Expert or similar), particularly in Mammalian Cell cultures.
Demonstrated knowledge of legacy, current-gen and next-gen vaccine manufacturing technologies.
Strong understanding of clinical and commercial Manufacturing processes and Manufacturing constraints.
Strong understanding and knowledge of process industrialization methods.
Strong understanding of industry trends.
Understanding in continuous manufacturing, Systems Biology (-omics), big data, multivariate analysis, predictive analytics and modelling approaches.
Interpersonal and influencing skills to engage different stakeholders inside and outside the Technical RD organization.
Ability to work in a dynamic multidisciplinary environment
Ability to embrace changes positively and to adapt.
Imprinted with a desire for excellence.
Optimistic and open-minded.