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’s 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! “
In regards of our industrialization phase and the commercialization of our NfinityTM platform, we are looking to strengthen our operations department and have open a position as Head of Product & Technology within Quantoom Biosciences!
You will lead several teams in charge of the development, the industrialization, and the qualification of our product range (equipment, single use and reagent mixes) that are part of our Nfinity platform.
MISSION:
As
Head of Product & Technology, your mission will be leading the industrialization of our current mRNA platform called Ntensify (process and equipment) as well as the development and the industrialization of next generations of mRNA technology.
RESPONSIBILITIES:
Business
- Participate actively in the development of the company by conceiving and implementing business strategies, operating plans and procedures that support the company long term strategy for the implementation of the equipment, the single use disposables and the reagent mixes that are part of the mRNA platform.
- Create an operational plan for the Nfinity platform for its development and industrialization, convey to the teams persuasively, and conduct business in a manner consistent with the values, vision, and mission.
- Manage and supervise all aspects of the Equipment Development & Industrialization as well as the Process Development, including staffing and personnel allocation, budgeting to strongly support program management delivering projects within agreed quality standards, budgets and timescales.
- Assess and manage the principal risks within operations and assume ultimate responsibility for all functional and process-related issues arising from or within the Product & Technology department.
Operational
- Manage and control department expenditure within agreed budgets.
- Manage relationships with partners/vendors.
- Develop and maintain records to comply with appropriate regulatory requirements.
- Generate, review and approve documentation.
- Comply with organization’s quality and EHS policies.
- Support and coordinate managers and teams’ efforts to maximize group productivity and resolve potential conflicts.
Team Management
- Promote a continuous improvement philosophy in operations, evaluating current practices and refining them as needed to meet company goals more effectively and build an organization of top-quality staff.
- Ensure training of staff to be adequate for future needs and act as coach, mentor, and leader to remove all impediments to the teams to enable success.
- Maintain a positive and ethical work climate that is conducive to attracting, retaining and motivating a diverse group of top-quality employees at all levels.
- Identify and propose infrastructure and process improvements to enable teams to be successful.
General
- Lead the Product & Technology department composed of several teams with specific expertise, which include hardware, software, single-use and process development and industrialization i.e. design of new equipment (hardware and software), design of a new disposable single-use device, development of a new mRNA process, all to be integrated in platform. Both engineering and process development teams are working in close collaboration to achieve the best design fitting with the process requirements like we have done with our first Ntensify product range commercialized in Q2/2023. The teams will ensure also the contruction of equipment and disposables in collaboration with industrial partners, then will ensure the qualification in collaboration with Service team (in charge of Factory Acceptance testing and qualification. A strong collaboration with Quality team is also needed.
- Lead the team to ensure that user requirements and design specifications are met for equipment and disposables. The team, in close collaboration with Quality department and Service Team, will perform design reviews, factory acceptance testing, installation verification, and functional testing with summary reports, then perform the Installation and Operational Qualifications.
- Lead the Process Industrialization team that will perform the process transfer (external and internal), the process improvement and the trouble shooting activities. For this purpose, the team will work with customers, internal and external partners by providing tactical and strategic technical support to them.
- Collaborate with Program management and supply chain during the entire project development, industrialization, and manufacturing phases during the entire life cycle of the product.
- Collaborate with Product management team, part of Marketing & Sales organization, to ensure user requirements specifications.
- Collaborate with the Head of Quality to improve our product quality, our business quality processes and procedures as well as be audit ready.
PROFILE & EXPERIENCE:
- Master’s degree in engineering or science
- Proven track record of managing all aspects of a successful product/project throughout its lifecycle.
- 10-15 years combined experience in equipment development, industrialization, and qualification and/or process development, preferably in pharma equipment manufacturers, Pharma/Biotech or Medical devices sectors.
- Skilled in project management methodology.
- Solid technical background. Biotechnology process knowledge is a plus.
- Strong management and leadership, as well as influential skills.
- Skilled at working effectively with cross functional teams in a matrix organization.
- Expertise in leading teams of engineers, scientists, and technicians.
- Strong analytical skills to distil key information from data.
- Strong in communication skills and team player.
- Ability to work in a fast-paced environment and able to combine strategic and tactical actions.
- Fluent English, French is an asset.
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