Director, Manufacturing Operations (Gaithersburg, MD)*

  • Gaithersburg, Maryland
  • Work experience
  • Production, manufacturing
scheme image

Director, Manufacturing Operations (Gaithersburg, MD)*

Become Part of the BioNTech Family.

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.

Position is based in Gaithersburg, MD 

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 executing cGMP manufacture and supply of BioNTech‘s cell therapy clinical trial materials and managing the manufacturing function at the Gaithersburg, MD site.  The candidate will report to the US head of Technical Operations and work in close collaboration with the local Gaithersburg organization as well as US and Corporate Technical Operations in Cambridge, MA and Germany.
 

Here, you’ll achieve greatness.

Supporting BioNTech’s team in the US by:
   
  • Manufacture and supply of cell therapy products for US clinical supply in accordance with clinical demand, turnaround requirements and budget
  • Maintenance of cGMP compliance and product quality through systematic control, analysis and continual improvement
  • Oversight of deviation remediation, investigations and corrective/preventative actions
  • Management and development of manufacturing and supply chain staff
  • Oversee development and maintenance of master production records and standard operating procedures in support of manufacturing and equipment operations
  • Production forecasting and capacity management
  • Manage and evaluate cost of goods and turnaround time
  • Provide weekly and monthly progress reports
  • Develop and manage annual objectives, schedule and budget
  • Partner with Process Development in the planning and execution of new product transfers and technology into manufacturing
  • Provide leadership and representation for local manufacturing expansion, corporate initiatives, product development teams and other projects
  • Contribute to corporate manufacturing strategy and business continuity measures

What you have to offer.

  • Minimum requirements; BS or MS in Chemistry, Engineering or Life Science with 15+ years of cGMP manufacturing experience and 10+ years supervising staff
  • Extensive experience and expertise in cGMP cell therapy (or biologics) and aseptic manufacture
  • Expertise in process validation
  • Strong leadership, risk management and project management skills
  • Function building and staff development experience
  • Expertise in problem solving and leading investigations
  • Excellent communication, interpersonal and collaboration skills.  Ability to work within cross-functional teams.
  • Attention to detail and well organized
  • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willingness to think outside of the box and adapt best practices in a constantly evolving environment
  • Self-motivated with a strong sense of ownership and accountability in areas of responsibility
Preferred Qualifications; Experience in mRNA, vector and/or peptide manufacturing. 

Benefits for you.

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. 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, 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
Plus more benefits that will be shared upon hire!

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge (Boston) 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 careers@join-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!


https://biontech.de/biontech-us

www.biontech.de