Director* IMP Supply QA
- Cambridge, Massachusetts
- Work experience
- Manager First Level
- Quality Management, Quality Assurance
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* IMP Supply QA
Your main responsibilities are:
- Leading the IMP supply group to ensure efficient team activities
- Supervision of internal interfaces involved in the IMP manufacturing work flow to ensure compliant supply
- Ensuring compliant manufacturing and release of IMP to match supply demand according to production plans
- Execution of critical decision making related to clinical trial supply (CTS) operations
- Continuous assessment of CTSM requirements and operations with impact on quality related processes
- Accountable to ensure compliant supply of IMP post release
What you have to offer.
- University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
- Multiple years of work experience in quality assurance, quality oversight or relevant experience, ideally in a biotech or pharmaceutical company
- Strong Experience in contract manufacturing or in dealing with contract manufacturers
- Profound knowledge of EU GMP and FDA regulations for clinical manufacturing
- Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
- Refined colloquial and correspondence skills in both German and English
- Desirable: Experience in dealing with cell and gene therapeutics
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
Then apply now and simply send us your application documents using our online form.
For those who require assistance due to disability, or have questions prior to applying, please email careersjoin-us.biontech.de.
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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