CMC Project Manager position
Job description
You will join a young Biotech Deeptech in the development phase of a very innovative nasal subunit vaccine, strongly supported by the MESRI and ANRS-MIE. This project was classified as a “National Priority”, we designed the clinical study protocols and selected the Clinical Investigation Centers for our first vaccine against COVID-19.
We have completed pre-clinical studies and regulatory toxicity studies show the complete safety of our vaccine. We are currently at the end of the development phase and are ready to start manufacturing the vaccine solution in a GMP environment to begin the first clinical phases in 2024. Lovaltech has already started the development of new vaccines based on its technology in other therapeutic areas.
Your missions
Your first general mission is to secure the development and production stages of the vaccine solution until the release of clinical batches.
• Coordinate and monitor the manufacture and release of clinical batches: Excipients, Drug Substance, Drug Product and secondary packaging at our external partners (CDMO).
• Analyze, interpret and verify the consistency of the results with expected product specifications.
• Supervise the development and analytical validations of the Drug Substance and Drug Product.
• Ensure the implementation and the monitoring of the pharmaceutical development plan defined with the management team.
• Supervise and draft the regulatory documents necessary for regulatory submissions (IND and IMPD): module 3.
• Review Master Batch Records, and batch files.
• Manage the activity of subcontractors: define of needs, selection, contractualization and management of subcontractors CMO, CRO (planning, deliverables, budget).
• Coordination of the activities of external service providers and control of compliance with schedules.
• Frequent travel
• Partial telecommuting possible
Reporting directly to the Managing Director, you will be involved in the development of the strategy.
Required profile
• With a degree (PharmD, MSc or Engineer), you have 4 to 5 years' proven experience in a similar position in an industrial environment (pharmaceutical industry, biotech).
• Knowledge/mastery of of drug substance and drug product batch manufacturing processes in GMP environments.
• Experience in GMP production, biologics, recombinant proteins, nanoparticles, particularly in the analytical aspect of processes.
• Solid understanding of pharmaceutical regulations, quality constraints and good manufacturing practices.
• Good team spirit and ability to work in an interdisciplinary environment.
• Autonomy and responsibility in decision-making and task execution in the management of pharmaceutical development projects.
• Excellent oral and written communication skills (English and French).
• Fluent English
The company :
We are a Biotech created in January 2022 by 4 partners including 2 Executives, Patrick Barillot, President and Isabelle Dimier-Poisson, CSO and you will report to our CEO, Serge Pampfer who recently joined the company.
Lovaltech is labeled DeepTech by BPI France and was the winner of the i-Lab call, and i-Démo #France 2030 this year for a global budget of €8.4 million.
Lovaltech is developing a nasal protein vaccine which will be the first active vaccine against current and future variants of the Coronavirus, capable of stopping the transmission of the virus and therefore the contagiousness, benefits to which are added excellent stability allowing it to be stored at temperatures positive.
The added value of Lovaltech lies in the ability of our technology to induce a mucosal immune shield against pathogens, based on specific neutralizing antibodies (IgA), and we are already working on other pathologies through our technological platform.
Lovaltech is based in Tours (37)