(Associate) Director, Manufacturing Operations (Cell Therapy)*
- Cambridge, MA
- Work experience
- Production, manufacturing
- Project Management, Product Management
Associate Director/Director, Manufacturing Operations (Cell Therapy)*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech US is seeking a highly-motivated individual with cGMP cell therapy manufacturing experience to join the BioNTech US Technical Operations group. The candidate will be responsible for overseeing the manufacture of BioNTech US’s cell therapies at contract manufacturing organizations. The candidate will report to the head of Technical Operations and work in close collaboration with the Process Development, Manufacturing Sciences, Supply Operations, Quality Control and Quality Assurance groups.
Here, you’ll achieve greatness.
- Oversee the manufacture of cell therapy products for clinical supply in accordance with strict timelines and budget
- Production forecasting and capacity management
- Review and approval of executed batch records
- Manage meetings and communication with contract manufacturing organizations
- Oversee tech transfer and process improvement projects
- Manage and evaluate cost of goods and turnaround time
- Provide weekly and monthly progress reports
- Develop and manage annual objectives and budget
- Oversee manufacturing change controls, investigations, SOP development, and validations
- Contribute to department strategy and business continuity measures
What you have to offer.
- BS or MS in Chemistry, Engineering, or other Life Science with 8+ years of cGMP industry experience and 4+ years in supervisory/management role
- Extensive experience and expertise in cGMP cell therapy and aseptic manufacture
- Experience in mRNA and/or peptide manufacture a plus
- Expertise in process validation
- Experience working with cGMP contract manufacturing organizations
- Strong leadership, risk management and project management skills
- Function building and staff development experience
- Expertise in problem solving and leading investigations
- Excellent communication and collaboration skills
- Ability to work within cross-functional teams
- Attention to detail and highly organized
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?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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