Process Validation Lead
Il y a 6 mois
A propos
Yposkesi, an SK pharmteco company, is one of Europe’s largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy viral vector manufacturing. A one-stop shop for biotech and pharmaceutical companies seeking to advance clinical trials and commercialize new Advanced Therapy Medicinal Products (ATMPs), Yposkesi offers a full range of services in lentiviral vector and AAV (Adeno-Associated Virus) vector development and cGMP manufacturing. Yposkesi is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France, and currently employs ~200 people.
Description
We are currently looking for a Process Validation Lead. Are you ready to join the exciting field of Cell and Gene therapy?
Votre mission
About the role
Based in the Technical Development group, but leading projects across the organisation, the Process Validation Lead will bring a deep understanding of process validation systems and strategies to the validation of gene therapy drug substance and drug product manufacturing processes for our client projects at Yposkesi. The role has two main areas of focus: 1) execution of process validation studies (DS and DP) and 2) development of ProVal strategies and systems. External collaboration with clients and international consortia is also an important part of the role.
Key responsibilities
Develop process validation strategies and systems for validation of gene therapy drug substance and drug product manufacturing processes. Standardise approaches for similar studies across different products / projects where possible;
Define, write and approve supporting documentation, and execute ProVal studies for different aspects of both drug substance (e.g., holding time, resin re-use, PPQ, etc, studies) and drug product (e.g., APS, E&L, container, etc, studies) manufacturing;
Work collaboratively across different departments, including Manufacturing and Quality;
Participate actively in the site APS ([DP] Aseptic Process Simulation) committee, which defines and manages the site APS strategy and activities;
Build and lead a process validation team in the coming years as ProVal activities continue to increase;
Maintain alignment with client and regulatory expectations for validation of biomanufacturing and gene therapy manufacturing processes;
Participate actively in international consortia (e.g., BioPhorum C> Yposkesi is a member company) to collaboratively define best practices for validation of gene therapy manufacturing processes;
Represent process validation activities in meetings with clients (e.g., definition of validation strategies, progress of ongoing studies, etc).
Profil recherché
•MSc in Biochemical Engineering, Biotechnology or life sciences;•Experience: ideally 3-5 years of experience in an applied setting, with experience of working in multi-disciplinary teams, particularly with Quality and Manufacturing/Production Units;•Good oral and written English skills (B2 level); intermediate level in French (B1 - B2) – ability to write standard protocols and provide training on the protocols in French;•Solid understanding of biomanufacturing processes (e.g., monoclonal antibodies, vaccines, cell or gene therapies), preferably covering both drug substance and drug product; a profile in small molecule manufacturing only may not be suitable for this role;•Strong understanding of biomanufacturing process design, development, characterisation and validation required. Previous experience in development of process validation strategies required. Previous experience in execution only of ProVal studies may not be suitable for this role, neither would a background only in validation/qualification of equipment or manufacturing utilities/systems (e.g., IQ/OQ/PQ, SIP, COP, etc);•Understanding of GMPs and the regulatory environment for production of biologics, vaccines, or Advanced Therapeutic Medicinal Products (ATMPs);•Collaboration oriented: ability to understand and appreciate different technical points of view, and align on a path forward. Problem-solving and optimistic approach;•Self-directed and self-motivated. Demonstrated ability to work both independently and also as a team member in a matrix environment;•Client oriented: establishes effective and responsive relationships with clients;•Project management: ability to define a project in steps from initiation to closure, including success criteria, then develop a plan accordingly, track progress versus plan, and clearly communicate this to stakeholders.
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