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Lead Specialist in Process Validation
Il y a 3 mois
About Yposkesi
Yposkesi, a part of SK pharmteco, stands as one of Europe's premier Contract Development and Manufacturing Organizations (CDMO) specializing in gene therapy viral vector production. We provide comprehensive services for biotech and pharmaceutical enterprises aiming to propel clinical trials and bring Advanced Therapy Medicinal Products (ATMPs) to market. Our facility is situated in Corbeil-Essonnes, France, and is home to approximately 200 dedicated professionals.
Position Overview
We are in search of a Process Validation Lead to enhance our capabilities in the dynamic realm of Cell and Gene therapy.
Key Responsibilities
The Process Validation Lead will be an integral member of the Technical Development group, spearheading projects throughout the organization. This role demands a profound knowledge of process validation methodologies and frameworks, specifically tailored to the validation of gene therapy drug substance and drug product manufacturing processes. The position encompasses two primary responsibilities:
- Conducting process validation studies for drug substance (DS) and drug product (DP).
- Formulating and refining ProVal strategies and systems.
Collaboration with clients and participation in international consortia will also be vital components of this role.
Specific Duties Include:
- Designing and implementing process validation strategies for gene therapy manufacturing processes.
- Standardizing methodologies for similar studies across various projects when feasible.
- Drafting, reviewing, and approving essential documentation while executing ProVal studies related to both drug substance and drug product manufacturing.
- Engaging collaboratively with diverse departments, including Manufacturing and Quality.
- Actively participating in the site APS (Aseptic Process Simulation) committee to shape and oversee the site’s APS strategy.
- Building and leading a process validation team as ProVal activities expand.
- Ensuring compliance with client and regulatory standards for biomanufacturing and gene therapy processes.
- Contributing to international consortia to establish best practices for gene therapy manufacturing validation.
- Representing process validation efforts in discussions with clients regarding validation strategies and study progress.
Candidate Profile
• A Master’s degree in Biochemical Engineering, Biotechnology, or Life Sciences.
• Ideally, 3-5 years of relevant experience in a practical environment, with a background in multidisciplinary teamwork, particularly with Quality and Manufacturing sectors.
• Proficient in English (B2 level) and intermediate French (B1-B2), capable of drafting standard protocols and conducting training in French.
• Comprehensive understanding of biomanufacturing processes, including monoclonal antibodies, vaccines, and cell or gene therapies, with experience in both drug substance and drug product validation.
• Strong grasp of biomanufacturing process design, development, characterization, and validation, with prior experience in developing process validation strategies.
• Familiarity with GMPs and the regulatory landscape for biologics, vaccines, or ATMPs.
• Collaborative mindset with the ability to appreciate diverse technical perspectives and align on solutions.
• Self-motivated and capable of working independently as well as part of a team in a matrix environment.
• Client-focused, establishing effective relationships with stakeholders.
• Proficient in project management, from initiation to completion, including defining success criteria and tracking progress.
