(Associate) Director* IMP Management
- Cambridge, Massachusetts
- Work experience
- Project Management, Product Management
Become a member of the BioNTech Family!
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.
Associate Director* IMP Management
- Accountable for leading IMP Management activities, capabilities and resourcing capacity to assure efficient and compliant study medication demand forecasting, resupply planning, label design, packaging, IRT (Interactive Response Technology) set-up and distribution, destruction, drug accountability for study and comparator drugs, placebos, and ancillary supplies across multiple R&D Programs and drug platforms to meet company´s milestones, and provide guidance regarding logistics and feasibility on overall clinical development strategy
- Lead IMP-related activities within multifunctional internal and external R&D Programs and provide guidance regarding logistics and feasibility on overall clinical development strategy (e.g. selection of countries, storage temperature, dosage form) and active contribution to clinical core documents.
- Lead organization-wide process improvement activities related to IMP manufacturing, distribution and logistics with increasing complexity to ensure operational efficiency.
- Responsible to lead, coordinate, and implement cross-functional standards and processes to meet multi-national GxP (GCP, GMP and GDP) compliance (processes, documents) of Clinical Trial Supply Management activities for assigned R&D Programs/platforms/ areas of responsibility.
What you have to offer.
- Degree or vocational training in scientific or related field and several years of professional experience in the pharmaceutical industry or biotechnology and proven track record of clinical supply chain, logistics set up & management in global clinical trials up to Phase III
- Expert knowledge in GMP, GDP, GCP and in their implementation. Proven expertise in supplying several clinical studies up to phase III with investigational medicinal products
- Many years of experience in working with external CMOs and CROs in an international environment. Experience in the creation and adaptation of SOPs for complex processes
- Experienced handling of MS Office and knowledge of Interactive Response Technology Systems (IRT)
- Strong analytical and organizational skills added with very strong collaboration, team- and alignment-building skills
- Effective stakeholder management, both in cross-functional internal and external matrix team environment
- Excellent organization and communication skills as well as highly motivated and open-minded team player, enjoys working in a team and is able to motivate a team
- Business-professional English language skills are mandatory, good German language skills are advantageous
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 2591 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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