Job Description
Mission
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- The USP (UpStream Process) Manufacturing Lead acts as a transversal subject matter expert in USP processes to enable robust manufacturing capabilities from R&D to GMP.
Key responsibilities:
Strategic
- Enable the design and implementation of robust and scalable manufacturing process in line with customers and regulatory authorities’ expectations.
- Raise technical excellence and innovation within the department.
- Participate in ensuring department goals and metrics meet or exceed expectations.
- Identify initiatives and investments with significant impact on department objectives.
Operational
- Closely collaborate with (senior) scientists within the team to drive the design and implementation of robust and scalable manufacturing process from development to commercialization.
- Interact with DSP (DownStream Process) & AD (Analytical Development) to ensure holistic approach.
- Maintain up-to-date knowledge of viral vectors manufacturing and provide recommendation regarding process innovation and improvement, data management solutions, new equipment and raw materials.
- Perform review of process flow, footprint, batch records, process data (parameters and outputs). Identify potential risks or trends and recommend process improvements or mitigation plans when needed.
- Provide technical expertise for process readiness and risks assessments including: Facility Fit Gap Assessments (FFGA), critical process parameters and raw materials Risk Assessment, Failure Mode and Effects Analysis (FMEA).
- Provide technical expertise to design supportive studies such hold times definition, stability testing, shelf-life definition, cleaning strategy, re-use and lifetime definition, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, extractible & leachable, viral clearance.
- Support deviation investigations, identify relevant Corrective and/or Prevention Actions (CAPAs), and Change Controls when applicable.
- Ensure harmonization of manufacturing solutions (incl. assemblies, buffers) from R&D to GMP,
- Provide technical support to business team in their interactions with customers among which: design of scope of work, timelines and costs definition.
- Act as a coach with junior people and participate in developing technical skills across the department.
- Adhere to Quality standards, cGMP requirements and EHS practices.
Education and skills
- Master/Ph D degree in a life sciences or Chemical Engineering discipline and a minimum of 6 years of relevant experience in Process development, transfer, characterization, validation and life cycle management for biologics, vaccines or cell/gene therapy.
- Knowledge in biostatistics and analytical methods
- Strong leadership skills and ability to work cross-boundaries.
- Excellent written and verbal communication skills at all levels in the organization.
- Language skills: French and English
- Promote a productive and cooperative climate by engaging in a trusting, supportive partnership with others, and solve conflicts in a constructive manner that allows win/win solution.
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