Specialist, CTSM Logistics (Individualized mRNA cancer vaccines)
Cambridge, US | full time | Job ID: 7340
Position Summary
At BioNTech, we are revolutionizing the future of oncology through cutting-edge research and innovative therapies. We are currently seeking a highly motivated and experienced Specialist, Clinical Trial Supply Management (CTSM) Logistics to assist Operations and Clinical Development in coordinating and managing the distribution of drug products (DP) to Contract Manufacturing Organizations (CMOs), clinical depots, and directly to Clinical Sites. You will play a crucial role in ensuring the smooth and compliant distribution of our clinical products, specifically supporting BioNTech's individualized mRNA cancer vaccine trials.
Key Responsibilities:
- Liaise with GMP to set up DP shipments to CMOs and to release kits to clinical depots
- Conduct distribution planning
- Manages import / export license application
- Define shipping solutions and transit monitoring
- Supplier-Relationship-Management as well as aligning with vendors on timelines, processes and issue solving (deviation)
- Perform cumulative TE-tracking
…and many more exciting tasks await you
Requirements:
- A Bachelor's degree required with a minimum of 3-4 years experience in the field of clinical distribution planning / logistics management
- Knowledge in the areas of regulations, ISO requirements and with the according laws for pharmaceutical/biotech products
- Experience with import/export requirements for pharmaceutical/biotechnology products
- Cold chain management experience, specifically temperature monitoring devices, calibration requirements, and basic understanding of GDP Principles (e.g., Documentation, Operations, etc.)
- Excellent communication skills
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Self-motivated with a proven track record of problem-solving in a regulated environment
Your Benefits:
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.
Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Apply now - We look forward to your application!
Apply for our Cambridge, US location and simply send us your documents using our online form.
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 our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.