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Senior CMC Project Leader, Process and Product Design
Permanent position
Toulouse France
Just-Evotec Biologics is seeking a Senior CMC Project Leader (Senior Principal Scientist or Director, depending on level of experience) to support our mission of advancing low-cost biotherapeutics manufacturing to provide access to all. The position sits in the Process and Product Design Group and leads cross functional CMC development teams for commercial process development of biologics and biosimilars using our innovative continuous manufacturing platform. The Senior CMC Project Leader has a deep understanding of late-stage biologics development and establishes comprehensive development and characterization strategies with our external partners and internal stakeholders, including project management, alliance management, manufacturing operations, quality, regulatory, pre-clinical and clinical groups. This position requires strong cross-management, communication and leadership skills, strong scientific and critical thinking, a strategic mindset, and the ability to proactively identify and mitigate risks.
Key responsibilities
Lead the scientific/technical activities of a cross functional, matrixed team of scientists/engineers responsible for executing development, validation and manufacturing activities for late stage biotherapeutics or biosimilars for our partners with both strategic and operational focus.
Work closely with project management, alliance management, other internal functions and our partners to develop and continuously refine an integrated CMC strategy in a dynamic environment to expedite the successful process development, regulatory approval and commercialization of the partner’s projects.
Manage CMC timelines from a technical/scientific perspective; perform risk management activities, including implementing processes to identify and evaluate risks, proactively execute mitigation plans to ensure effective program execution.
Work with functional leads & managers to identify, communicate and resolve resources constraints as needed.
Ensure that development plans, experiments and data meet a high level of scientific, technical, quality and regulatory rigor and are executed on time and within budget to meet project deliverables.
Develop and refine regulatory communication and strategy, both written and face-to-face.
Collaborate with other CMC Leaders to align on project strategies and tactics, define best practices for development and characterization and identify areas of improvement to further our mission of access for all.
Position Requirements- 12+ years relevant experience in the biopharmaceutical industry.- Engineer or PhD in a relevant field (e.g. biochemistry, molecular biology, chemical engineering) or extensive relevant experience in industry.- Excellent interpersonal, team and communications skills are a must- Excellent writing, organization and presentation skills- Significant experience with regulatory filings including MA/BLA- Experience with capacity planning tools and allocation of resources- Knowledge and expertise to solve complex technical problems and commitment to innovation and continuous improvement- Entrepreneurial drive to achieve business objectives and ability to manage ambiguity in a dynamic environment.- Experience developing and launching biosimilars is preferred
