In this position, you will play a central role in preparing biopharmaceutical processes for commercial manufacture. Working alongside cross functional teams as well as external testing facilities and contract manufacturers. You will ensure that processes, documentation, and technical knowledge move smoothly into a commercial environment. You will also be a key interface for regulatory-relevant activities across the product lifecycle.
Key Responsibilities
* Oversee the transfer of late-stage or commercial processes to internal or external manufacturing sites, ensuring all technical elements are ready for execution.
* Lead the creation, review, and coordination of transfer packages, including risk evaluations, technical assessments, and operational documentation.
* Consolidate background process information and ensure that commercial documentation is complete, accurate, and maintained over time.
* Support ongoing commercial production by monitoring process performance, addressing deviations or issues, and proposing improvements where needed.
* Work closely with manufacturing teams during production campaigns, offering technical guidance and resolving challenges in real time.
* Drive initiatives aimed at enhancing process robustness and efficiency in collaboration with development and operational groups.
* Participate in regulatory inspections and internal audits, providing process knowledge and evidence for compliance activities.
* Contribute to periodic reviews of process performance and long-term lifecycle management activities.
Profile We’re Seeking
* Advanced degree (Master’s or PhD) in a life science or engineering field related to biotechnology or bioprocessing.
* Strong experience leading Drug Substance tech transfers.
* Strong understanding of biologics production principles and commercial manufacturing environments.
* Experience coordinating cross-functional scientific or technical initiatives.
* Clear and confident communicator in French and English.