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Industrialisation Expert (M/F)

October 15th 2020

At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes, and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!

Mission Description

Process development & scale up

Work in collaboration with the Vaccines technical development team on the design of the final process and on the scaling-up to the final process by taking into account the manufacturing constraints

Ensuring the proper implementation of Process Characterization activities in the Technical Development department :

Identify the CQA, the CMA and the CPP with the Development team.
Works in collaboration with Vaccines Development teams to perform the Process design and process characterization.
Works in collaboration with Vaccines Development teams and QC to establishment of the Controls Strategy and ensure analytical method validation.
Support the Manufacturing unit to generate the Process Validation Master Plan.
Support the Manufacturing unit for Process Qualification (Engineering run, validations and PPQ campaign).
Support the Manufacturing unit for the establishment of Continuous Process Verification plan and for its implementation
Technology Transfer

Carry out the Technology Transfer of vaccines processes from Vaccine Technical Development teams (Upstream, Downstrean, Analytical) to the Pilot Plant
Support the Technology Transfer of vaccines processes from the Pilot Plant to the Commercial production unit.
Ensure the Technology Transfer of analytical methods from Analytical development team to QC unit.
Carry out the Technology Transfer by involving RA, QA, QC, Project Management, Facilities and Procurement departments.
Lead and manage interactions between teams to create the required documentation (Tech Transfer plan, Tech Transfer report, …) by respecting internal quality system
Reporting

Writing and management of documentation related to the Technology Transfer and Process Characterization : plans, reports
Quality, Safety & continuous improvement

Adherence to standard operating procedures and guidance in all described activities.
Correct use and implementation of quality management system within the field of activities.
Identification and reporting of deviations from standard operating procedures and of unexpected events through initiation of related investigations.
Support of corrective and preventive actions related to deviations and unexpected events.
Generation of process quality documentation for vaccines platform (procedures, work instructions, templates, etc.).

Candidate profile

Master Degree with a minimum of 3 years experience in industry
Minimum 3 years of experience in Vaccine production processes, Technology Transfer and Process Characterization/Validation..
Full understanding of compliance and cGMP considerations
Excellent communicator with the ability to transfer knowledge and give confidence to customers
Driven by curiosity and eager to learn more every day. With a strong desire to be impactful.
Self-motivation and interest in fast-growing companies/SMEs.
Integrity and transparency.
Strong sense of observation, inventive & critical mindset, scientific curiosity and problem-solving skills.
Proactivity, flexibility, work organizational skills
Enthusiasm and agility to work on a variety of projects.
Capability to leverage know-how in order to participate in the development of the new generation solutions.
Capability to work in a cross-functional and multi-cultural team.
Fluent in English (written and spoken).
 

Offer

For more informations please contact to Univercells

Contact Details

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