Associate Director, Innovation

Il y a 19 heures

Fresnes, Ile-de-France PathoQuest Temps plein
PathoQuest, a Charles River company, is a global Contract Research Organization (CRO) specializing in NGS-based biosafety quality control. Through its iDTECT® analytical platform, PathoQuest enables the rapid and safe market launch of biotherapies for patients. We provide validated, Good Manufacturing Practice (GMP)-compliant testing services for viral safety testing and genetic characterization of raw materials, cell and gene therapies, monoclonal antibodies, and vaccines. Our analytical services are available at our sites in Paris, France, and Wayne, Pennsylvania. We are currently looking for an Associate Director, Innovation & Development. Role Overview The Associate Director, Innovation & Development is responsible for leading scientific innovation, assay development, validation programs, and lifecycle management of NGS products and services within a GMP-regulated environment. The role drives strategic innovation initiatives, provides scientific and technical leadership, supports regulatory compliance, and collaborates cross-functionally to develop, validate, implement, and continuously improve technologies and service offerings that support organizational growth and client needs.

Key Responsibilities
Innovation Monitor, assess, and communicate emerging scientific, technological, regulatory, and market trends within the industry. Develop and maintain a strategic innovation roadmap aligned with organizational growth objectives and client needs. Identify opportunities to expand and improve NGS service offerings through new technologies, workflows, platforms, and analytical approaches. Develop business cases to support investment in new technologies and service capabilities. Lead innovation initiatives from concept evaluation through proof of concept, development, and implementation. Represent the organization externally at scientific conferences, industry forums, client meetings, and through scientific collaborations. Scientific Support Serve as a senior scientific expert in NGS technologies, assay development, and analytical methodologies. Provide technical guidance and scientific mentorship across project teams and laboratory functions. Review and evaluate scientific data, development studies, validation packages, technical reports, and client deliverables. Maintain awareness of evolving industry standards, regulatory expectations, and best practices relevant to the services provided. Validation Program Leadership and Lifecycle Management Oversee method development, assay optimization, feasibility studies, and technology evaluations in collaboration with the Director of Technical Operations. Ensure validation programs comply with internal quality standards, regulatory requirements, and industry best practices. Collaborate with Quality, Regulatory Affairs, Operations, Bioinformatics, and Laboratory teams throughout project execution. Ensure projects are delivered on schedule, within scope, and in alignment with strategic objectives. Liaise with the Director of Technical Operations to establish and manage the lifecycle of commercial NGS products and services. Drive continuous improvement activities for existing assays, analytical pipelines, and laboratory workflows. Evaluate opportunities for process optimization, automation, digitalization, and cost reduction. Lead investigations related to technical performance trends, platform upgrades, and obsolescence management. Support change control activities and the implementation of technical improvements within GMP systems. GMP and Regulatory Ensure that scientific and technical activities comply with GMP requirements, company procedures, and applicable regulatory guidelines. Support regulatory inspections, customer audits, and internal quality audits as a scientific representative. Contribute to risk assessments, CAPAs, deviations, change controls, and quality system improvements. Promote a strong quality culture while enabling scientific innovation and continuous improvement. Ensure that appropriate documentation and data integrity practices are maintained across all scientific and technical activities. People Management (when assigned) Lead and develop high-performing scientific and technical teams. Provide mentoring, coaching, and performance management for direct reports. Support talent development, succession planning, and capability building within technical functions. Coordinate resources and priorities across multiple projects and stakeholders. Commercial Support Act as a technical representative during client discussions, technical reviews, and business development activities. Support proposal development, technical scoping, and project planning for new opportunities. Translate scientific capabilities into meaningful commercial value propositions. Support the successful technology transfer and implementation of client-specific solutions. Qualifications Master’s degree in Molecular Biology, Genetics, Genomics, Biotechnology, Biochemistry, or a related life science discipline. PhD preferred. Minimum of 6 years of relevant industry experience in related fields. Demonstrated experience working within GMP and regulated laboratory environments. Proven track record of leading R&D, assay development, validation, and technology implementation projects. Specific experience in NGS and/or Bioinformatics would be desirable. Experience managing complex cross-functional projects and scientific teams. Previous people leadership experience preferred. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Regularly provides and receives information through various technologies, media, sources, and contacts, and must be able to accurately exchange information in these situations. Location This position is based near our Paris office (13th arrondissement), France. Compensation Depending on the candidate’s experience. Why Join Us? A fast-growing environment within a dynamic, innovative, and ambitious scale-up. A company at the forefront of genetics, bioinformatics, and molecular biology. An attractive, high-profile global client portfolio. We thank all candidates interested in this position who meet the above criteria for submitting their CV to careers@pathoquest.com.