Senior CMC Leader (all genders)
Senior CMC Leader (all genders)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 partners projects.
Serve as subject matter expert and representative of the CMC function for global project teams and internal and external governance boards.
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
FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.
Required Experience:
Senior IC
Employment Type
Full-Time
