The Product Lifecycle Lead is responsible for defining global lifecycle strategies relevant to product commercialization.
These activities include the characterization, validation and monitoring of commercial processes according to Regulatory Authorities guidances.
He / She manages 1-3 programs with the support of a team of Scientists. This position reports to the Head of R&D and will be part of the R&D leadership team.
Roles and responsibilities :
Establish the global strategy and timelines for process characterization and validation by working closely with all relevant internal stakeholders (R&D, QA, QC, GMP Manufacturing) and customers.
Ensure strategy and plans are aligned with Regulatory Authorities expectations
Ensure implementation of risk-assessments associated to these activities
Ensure appropriate definition and evaluation of process parameters and outputs, with their ranges and classifications
Define Process Validation Master Plans including relevant technology transfer activities, readiness assessments and necessary supportive studies such as hold times, stability, cleaning, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, extractible & leachable, viral clearance
Provide on-site support to the commercial unit during the implementation and execution of the Process Performance Qualification campaign
Establish the Continued Process Verification strategy and define appropriate solutions for process monitoring (trends, deviations, process outputs)
For all above mentioned activities, ensure relevant documentation is produced in due time
Act as the Process validation lead during regulatory inspections
Be instrumental to site VMP definition and Annual Quality Reviews activities, acting as the process lifecycle SME
Master / PhD degree in a life sciences or Chemical Engineering discipline and a minimum of 8 years of relevant experience in Process characterization, validation and life cycle management for biologics, vaccines or cell / gene.
Min 5 years of experience in CMC environment, in particular fast-track / accelerated programs
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