Become a member of the BioNTech Family! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. (Senior) Director Biomarker Operations Biomarker Operations team planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery and cleaning process, long term storage and/or final sample disposition) Building and maintenance of efficient biomarker sample logistics (incl. set-up, tracking, analysis) until data delivery Expertly drive/lead team members; setup and lead workshops and conduct cross-functional lessons learned with internal stakeholders, vendors, and partners to continuously map and optimize processes related to the biomarker operations Oversee Biomarker Operation's inspection readiness by ensuring preparedness and compliance and support team members in connection to inspections/audits, including, but not limited to: development of inspection/audit material, participation, training, and presenting during audits/inspection, responding to audit and inspection of findings related to biomarker activities Drive development and implementation of new methodologies and procedures related to Biomarker Operations to ensure work is compliant and of high quality Participate in the relevant departmental activities e.g., due diligence activities, forums/workshops, lead/contribute to knowledge sharing sessions, etc Lead Biomarker Operations owned system implementations, meetings and initiatives and represent Biomarker Operations on relevant QMS and other systems initiatives, both internally and externally Support the assessment of resources needed for upcoming trials and projects Contribute to the continued building of a framework within the Biomarker Operations function focusing on growth and development of new and "innovative" ways to work with internal and external partners Adhere to guidelines, SOPs, practices, and technical and industry standards during all aspects of work Proactively support developing and reviewing standard processes and templates Work effectively and lead in cross-functional working groups Open for hire at one of the following locations - Mainz K1, Cambridge Erie Street, Gaithersburg, London. - Job ID: 5815 Master's degree or PhD in Biology, Pharmaceutical or other Science discipline 15+ years of experience in the Pharmaceutical/CRO industry managing complex Biomarker Operations and team Experience in strategic set-up of central laboratory operations, study start up, clinical sample tracking/reconciliation and analysis Proven experience with GCP environment and Lab Management System (e.g., LIMS) and knowledge in therapeutic areas like Oncology, Immuno-oncology, or Infectious Diseases 5+ years of experience in management of direct reports Proven track records of independent contributions to a strategic transformation of operations in CRO, Biotech/Pharmaceutical companies and/or central labs Strong global project management, problem solving, influencing, communication and leadership skills as well as high level of integrity, energy, and solution orientation, including an attitude to contribute to establishing clarity and structures Experience in developing and implementing agile, creative solutions, helping to solve business challenges within the organization and in partnership with external collaborators Demonstrated experience in establishing effective priorities for her/himself, while working with a sense of urgency, delivering on multiple projects and often dynamic deadlines Proven experience in working in a matrix organization and with international teams with ability to work autonomously and under time and workload pressure Excellent written and spoken communication skills in English, any other language is a plus Ability to influence and thrive in a matrix environment BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience. Click here to find out more about what we do, the careers we offer and also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
