Senior Director, Clinical Genomics Laboratory

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OverviewBioNTech is establishing a cutting-edge genomics hub in Cambridge, UK, to support our clinical studies and advance genomics approaches for our individualized mRNA cancer vaccine platforms. The laboratory will build substantial next-generation sequencing (NGS) capacities in Cambridge to support our clinical trials and individualized mRNA cancer vaccine manufacture via diagnostic applications and neoantigen discovery. We are seeking an experienced and visionary Site Head to lead and oversee the operations of a GxP-compliant genomics laboratory specializing in Illumina sequencing technology for whole exome sequencing (WES) and RNA sequencing (RNA-Seq).In this role, you will own the end-to-end management of the genomics workflow, ensuring seamless execution and impactful results. With your expertise in technology transfer, instrument qualification, analytical method validation, and laboratory information management systems (LIMS), you will set the standard for operational excellence and regulatory compliance.Your mission: Deliver high-quality genomic data that propels precision medicine and translational research forward. This role offers a unique opportunity to build a state-of-the-art clinical research site from the ground up and to shape the future of individualized cancer therapies. As the leader of a multidisciplinary team of NGS experts, technology developers, and researchers, you will foster collaboration across the UK clinical genomics network, driving progress and innovation.ResponsibilitiesLeadership and StrategyDevelop and execute the strategic vision for the genomics laboratory, ensuring alignment with organizational goals and clinical trial timelines.Lead the implementation and optimization of Illumina sequencing workflows for WES and RNA-Seq, focusing on diagnostic applications and neoantigen discovery.Drive innovation in laboratory processes while maintaining compliance with GCLP standards and regulatory requirements.Foster a culture of scientific excellence, collaboration, and continuous improvement within the laboratory team.Operational ManagementOversee the end-to-end genomic workflow, including sample reception, histology, blood processing, nucleic acid extraction, NGS library preparation, and sequencing.Manage laboratory resources, including personnel, equipment, consumables, and reagents, to ensure operational efficiency and scalability.Develop and monitor key performance indicators (KPIs) to track laboratory performance and identify areas for improvement.Regulatory Compliance and Quality AssuranceEnsure all laboratory processes comply with GCP for labs, CLIA, CAP, and other relevant regulatory standards.Lead instrument qualification, analytical method validation, and technology transfer activities to ensure robust and reproducible workflows.Collaborate with the QA team to implement and maintain a comprehensive quality management system (QMS).Prepare for and lead audits and inspections, addressing findings and implementing corrective actions as needed.Scientific and Technical ExpertiseProvide scientific oversight for Illumina sequencing workflows, including optimization of protocols for WES and RNA-Seq applications.Collaborate with bioinformatics teams to refine pipelines for neoantigen discovery and diagnostic applications.Integrate advancements in sequencing technologies and ensure validation for clinical trial standards.Technology Transfer and Instrument QualificationLead technology transfer activities for new workflows, ensuring seamless integration into laboratory operations and LIMS.Manage and optimize Laboratory Information Management Systems (LIMS) to ensure seamless sample tracking, workflow efficiency, data integrity, and integration with downstream analysis and reporting pipelines.Collaboration and Stakeholder EngagementServe as the main point of contact for internal teams and external stakeholders, including clinical trial sponsors, regulatory agencies, and collaborators, ensuring laboratory work aligns with project goals through coordination with clinical, bioinformatics, and research teams.Represent the laboratory at scientific conferences, industry meetings, and client presentations.QualificationsEducationPhD or equivalent advanced degree in Genomics, Molecular Biology, or a related field.ExperienceMinimum of 8-10 years of experience in genomics, molecular diagnostics, or clinical laboratory operations, with at least 3-5 years in a leadership role.Proven expertise in Illumina sequencing technology, including WES and RNA-Seq workflows.Extensive experience in technology transfer, instrument qualification, analytical method validation, and LIMS implementation.Demonstrated ability to manage compliant laboratories and support clinical trials.In-depth knowledge of regulatory standards (e.g., GCP for labs, CLIA, CAP) and quality management systems.SkillsStrong leadership and team management skills, with the ability to inspire and motivate multidisciplinary teams.Excellent problem-solving and decision-making abilities in a fast-paced, high-stakes environment.Exceptional communication and interpersonal skills, with the ability to build relationships with diverse stakeholders.BenefitsBioNTech is committed to the wellbeing of our team members and offers a variety of benefits. Remuneration packages are determined by the specific role, location of employment, and the selected candidate’s qualifications and experience. Availability and design of benefits may vary by location and are based on company policies and applicable law.How to applyApply now by sending your application documents including Curriculum Vitae, copies of degree certificates and professional certificates, a motivation letter, and your contact details via our online form.Please note: Only applications submitted through the online form will be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through HireRight. You will be informed accordingly by your BioNTech-Recruiter. #J-18808-Ljbffr
Location:
City Of London, England, United Kingdom
Job Type:
FullTime

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