Director CTSM individualized IMP Logistics
- Cambridge, Massachusetts
- Senior, very experienced
- Manager First Level
- 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.
Director CTSM individualized IMP Logistics
- Lead the Command Center to support clinical trial supply of individualized trials (e.g., Cell & Gene Trials) incl. resource planning, recruiting, guiding, supervision, coaching, developing team members
- Manage internal site set-up/configure electronic systems including user access and training
- Coordination of patient supply and act as main point of contact for internal/external stakeholders on patient scheduling (e.g., Apheresis collection/transportation, cryopreservation, manufacturing, release, and packing/shipment).
- Receive orders for patients and plan E2E Supply Chain milestones including slot scheduling
- Transforming logistics and order management process from R&D scale to global clinical scale to support rapidly growing pipeline.
- Build and scale a team to integrated automated chain of custody system then grow it to efficiently manage growing volume of orders and markets they are coming from within the personalized therapy platform.
What you have to offer.
- Degree in supply chain management, pharmacy, chemistry, biotechnology, or related discipline or engineer with profound understanding of clinical supply logistics
- At least 8+ years of experience in Clinical Trial Supply Logistics Management in pharmaceutical or biotech industry setting
- Very sound knowledge and documented experience in relevant legislation and international GDP guidelines
- Very sound knowledge in order management, slot allocation, and logistics coordination of individualized IMPs
- Experienced in setting up control tower operations for individualized IMPs
- Experienced with interfacing with Manufacturing, Clinical Operations, and Development organizations to coordinating capacity/demand planning associated control tower operations
- Demonstrated experience supporting clinical trials, submission to health authorities and inspection readiness activities
- Demonstrated quality management experience
- Proven track record of connecting logistics coordination teams to the warehouse, distribution, and manufacturing network for supply of personalized study drugs (set up and management) in global clinical trials up to Phase III
- Profound knowledge in customs regulations and impact of supply chain activities on product quality for personalized IMP
- Profound knowledge and experience in cold chain logistics including impact of product properties and stability on supply chain activities for personalized IMP
- Proven track record of effective capture and integration of latest clinical supply logistics trends for personalized IMP
- Relationship management with personalized IMP logistics service providers
- Compilation and coordination of regulatory documents associated
- Profound understanding of electronic systems supporting logistics Processes, Chain Of Custody processes (e.g., SAP, IRT, TempEZ, Orchestration Software) and standard office software proficiency (e.g. MS Office)
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 8015 (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!
BioNTech - As unique as you