BioLyo is looking to strengthen its team with a Director CMC Project Management and External Operations, to provide both internal and external project management oversight, and manage late phase clinical vaccine production activities at Contract Development and Manufacturing Organizations (CDMOs).
We are seeking a Biologics technical subject matter expert with extensive hands-on manufacturing experience in late clinical phase biological manufacturing operations, including process validation, commercial production, preapproval inspection readiness, and compiling the CMC section of Biologics License Applications (BLAs). Experience with fermentation, aseptic filling and lyophilization of biological drug products is a must, experience with live bacterial products is preferred.
Job Description:
* This role is based in Ghent, Belgium and reports to the CEO, and will manage several project managers in the growing team. Approximately 20% travel is anticipated to our CDMO in Portugal to enable effective oversight of production activities.
* Lead the outsourced BPZE1 phase III clinical manufacture project directly and act as BioLyo Technologies’ primary representative at CDMO.
* Person in Plant (PIP) at CDMO (Portugal) during manufacturing and other critical activities.
* Closely interact with the CDMO site staff (Project Manager, Quality, Production, Warehouse) and build a relationship of trust which fosters collaboration and open communication.
* Contribute expert knowledge of design, optimization, validation and continuous improvement of biologicals manufacturing processes.
* Oversight and hands on involvement in technical review of BPZE1 tech transfer and manufacturing documentation.
* Oversight of the team members involved in tech transfer and project management activities of other live bacterial product projects at CDMOs.
* Lead authoring of the process validation plan, with support from internal and external resources.
* Lead the authoring of Process Performance Qualification (PPQ) protocols (with support) and oversee execution of PPQ lot production at the CDMO as part of process validation, in close collaboration with BioLyo's Senior QA lead outsourced manufacturing.
* Deliver successful clinical and PPQ batches to support clinical programs and BLAs.
* Working with the BioLyo QA Lead Outsourced Manufacturing, support preapproval inspection readiness activities to ensure successful PAI at CDMO and BioLyo for QC lab activities.
* Working with the BioLyo QA Lead Outsourced Manufacturing, ensure compliance of the CMO with cGMP regulations, relevant procedures, Product Specification Files, and Quality agreements.
* Timely identification and communication of risks and gaps that could affect cGMP compliance and/or process performance; implementation of risk mitigation measures to close any gaps (ongoing effort).
* Establish timelines in collaboration with stakeholders, monitor execution and flag risks from the plan (supported by Project Managers).
* Drive regular project and steering committee meetings with the CDMO and Sponsor.
* Responsible for compiling and authoring CMC data for Module 3 of CTD (IND and MAA/BLA) in partnership with and direction from Sponsor company Regulatory Affairs.
* Will participate in Regulatory Agency meetings, responses and communications as requested by Sponsor company.
* Lead CMC-related internal projects at BioLyo aimed phase appropriate definition of design spaces using a DoE set-up as required, in close collaboration with the development team.
Education and Competences:
·PhD or Master’s degree in life sciences, biotechnology or Engineering, or equivalent by experience.
·Minimum of 15 years of experience preferably in a sponsor company overseeing outsourced manufacturing activities of biologics.
·Demonstrated experience with Process Performance Qualification (PPQ) and successful Biologic License Applications (BLAs).
·Expert knowledge of technical, quality and global regulatory requirements, specifically US FDA and EMA, for Phase 3 and commercial production, launch, and post-marketing requirements.
·Ability to lead, develop and motivate cross-functional teams.
·Strategic thinking and flexibility to integrate technical requirements.
·Autonomous and adept at pragmatic and risk-based decision-making.
·Excellent organizational and communication (verbal and written) skills.
·Fluent in English, written and spoken. Knowledge of Spanish or Portuguese is a plus.
Please send your application, including your CV and a motivation letter to info@biolyotech.com before May 10th 2025.
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