Quantoom Biosciences
Location
Fontainebleau, Seine et Marne | France
Job description
We are always looking for talented people to join the team! Discover our open positions or submit a spontaneous application!
Quantoom Biosciences has two facilities in Nivelles (Belgium), and Evry (France). At the headquarters in Belgium, our team is mainly focusing on the development of our RNA production platform, while our French team is focusing on the development of the end-to-end DNA production platform.
At Univercells , we are on a mission to make health equally accessible to all. Through the combination of process
development and engineering expertise, we create synergies to deliver game-changing production capacities
to achieve our mission: biologics for all!
At Quantoom Biosciences , Univercells’ latest affiliate, we are on a mission to remove the barriers to making
mRNA-based vaccines and therapeutics, at every stage from sequence up to mass production. We give our
partners greater access to drug development and production autonomy through technical and business model
innovation.
You will join an interdisciplinary team of passionate scientists, engineers, clinicians and corporate profiles committed
to solving some of the biggest DNA and RNA production challenges facing vaccines and therapeutics.
Quantoom Biosciences has two facilities; the headquarters are based in Nivelles (Belgium), and the France Research
Center focusing on offering an end-to-end DNA production platform based in Evry (France).
Every person will have the opportunity to contribute to our mission and be impactful. Apply and be part of this
great adventure! “
MISSION:
At Quantoom Biosciences , we are passionate about making vaccines and biotherapeutics accessible to all:
designing technology and processes to manufacture products in-country, developing vaccines against
emerging pathogens, and reducing production cost through manufacturing efficiency and innovative
processes.
With exciting projects in the pipeline, Quantoom Biosciences ’ vaccine development department is looking for a
Preclinical science and operations lead , focusing on the development of prophylactic and therapeutic vaccines
and vaccine (mRNA) platforms.
The role of the Preclinical science and operations lead is broad, and will encompass both the testing of
products for which the ultimate indication is intended to be for human health, and those with an indication for
animal health. The Preclinical science and operations lead will be familiar with the principles of in vivo
evaluation of vaccines including that for oncology indication(-s) and have a general familiarity with regulation
of human and animal medicines, principally vaccines.
Quantoom Biosciences is a dynamic organization with a startup footprint: collaborating with other staff and contractors,
the in vivo operations manager will work alongside other functions to deliver company objectives. In
collaboration with Quantoom’s in-house staff and expert contractors, you will drive scientific and operational
aspects of our in vivo evaluations. You will be part of a small team, and need to be able to work and deliver
independently while making informed decisions by training and knowledge.
Finally, Quantoom is developing innovative solutions to improve health using novel technology: outside-the box
thinking is encouraged.
PURPOSE:
The Preclinical science and operations lead will drive the day to day aspects of Quantoom’s preclinical plans
and support the translation of strategy into viable operational plans that deliver high quality data on time.
The Preclinical science and operations lead will help ensure excellence, compliance, bioethics, budgets and
reporting. They work alongside Quantoom’s experienced vaccine development, project management and
technical teams and with a diverse team of expert contractors. The applicant is expected to be experienced in
one at least of the two domains and interested in developing expertise in the other.
OBJECTIVES - RESPONSIBILITIES:
In collaboration with the Head of Vaccine Development, The Head of in vivo, Animal Science Lead, the PMO
and QA:
* Defines plans, goals, objectives, scenarios and budgets with appropriate support from a cross functional
team of in house and contract staff.
* Ensures appropriate oversight relevant to pre/clinical operations including:
o Study design and management of execution
o Risk identification, characterization and mitigation.
o Issue management and resolution.
o Contingency planning.
* Designs study operations and ensures appropriate documentation is prepared.
* Ensures the viability of the analysis plan and contributes to planning and analysis.
* Drives operational budgets and timelines
* Represents vaccine development department as appropriate at internal and external meetings.
* Drives high bioethical standards.
* Ensures timely and effective communication with relevant stakeholders
* Provides insight into operations in order to support strategic decision making
* Ensures in vivo evaluations are designed to be operationally feasible and will provide provide accurate,
meaningful data to inform decision making.
* Produces project plans and, in collaboration with relevant stakeholders, drives projects to plan.
* Ensures that GLP requirements for study related documentation are met.
* Acts as subject matter expert on in vivo operations.
* Ensures all studies are conducted to the highest bioethical standards….
REQUIREMENTS & QUALIFICATIONS:
* Relevant academic qualification up to post graduate level (Masters in relevant science subject
preferred). Preclinical operations are in scope for this role: post holders should be able to
demonstrate appropriate qualifications and experience that credibly demonstrates their suitability
for the role.
* At least 5 years industry or academic experience in a relevant role including oversight of preclinical
operations.
* Strong interest in the development of pharmaceutical interventions against infectious dieseases,
especially those impacting Low and Middle Income countries (LMICs) and oncology field.
* Direct experience on the design, conduct and analysis of preclinical (non-human) evaluation of medicinal
products.
* A good knowledge of epidemiology and relevant statistical methods, in particular infectious viruses and
emerging pathogens.
* Understanding of and direct experience with data analysis (supported by academic qualifications
and/or experience).
* Demonstrated expertise in ethics
* Experience in dealing with finance, budgeting and contracts, especially with contract research organizations.
* Capability to oversee project management.
* Experience and understanding of QA, QC and regulatory processes
* Strong knowledge of pharmaceutical development, ideally in the area vaccines and oncology
* Knowledge of GLP or GLP-trained or at least experience with Good Research Practices (GRP) for study
documentation.
* Good communication skills.
* Effective collaborator.
* Analytical skills.
* Fluency in English absolutely required; additional languages useful, especially FR or NL.
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