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Drug Product Development 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

  • He/she manages Drug Product projects and collaborates with external partners to ensure robust processes development with the best technical solutions to commercial vaccine product manufacture, with minimum complexity, cost of goods and meeting the agreed Quality Target Product Profile.
  • She/he gets involved in the conception, design, implementation, and interpretation of scientific and technical data to support projects.
  • She/he writes and reviews reports in support of various project.
  • She/he makes sound scientific / technical and business decisions based on a balance of data, analysis and experience.
  • She/he solves complex problems through collaborations with others, taking a new perspective on existing solutions
  • She/he provides state-of-the-art product and process expertise to support the Vaccines Deputy CSO & CTO, external partners, Univercells’ MSAT and Life Cycle Management team.  He/she establishes and maintains strong collaboration and interaction both locally and globally with internal and external partners and contribute to project plans for delivering the expected product and process innovations and knowledge.
  • The Drug Product Expert manages Technology Transfer of Drug Product production processes from sending units (external partners) to the receiving units (Univercells or other external partners).  She/he leads and manages interactions between teams to create the required documentation (Tech Transfer plan, Tech Transfer report, …) by respecting internal quality system.
  • The Drug Product is responsible for ensuring the proper execution of Process Validation activities by the external partners or by Univercells units.
  • Writing and management of documentation related to the Drug Product process development and project management.
  • 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

  • MSc or PhD degree in Science, Pharmacy, Biochemistry or equivalent life sciences degree with at least 5 years experience in pharmaceutical industry and in Drug Product development, preferably in vaccine formulation and drug delivery systems development
  • Proven scientific knowledge of Vaccines manufacturing and analytical testing.
  • Full understanding of compliance and cGMP considerations
  • Strong leadership combined with organizational planning and project management skills  
  • 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

For more informations please contact to: Univercells