Cell Therapy Manager


Become a member of the BioNTech Family!

Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.

 

 

Cell Therapy Manager 

 

Primary responsibilities Include:

  • Lead on the floor day to day manufacturing activities by learning and becoming a subject matter expert of all processes
  • Lead daily cross-functional Tier meetings to ensure adherence to department and site KPI’s
  • Responsible for manufacture and supply of cell therapy products in accordance with demand, schedule, and budget
  • Responsible for identifying issues and leading cross-functional teams to solve day to day and long term problems
  • Provide guidance, leadership, and feedback to ensure compliance and overall teams success
  • Set expectations and hold team members accountable for their performance and overall contributions to the team and company
  • Ensure the team is adhering to SOPs and cGMP regulations, with the ability to accurately complete documentation associated with GMP manufacturing.
  • Proactively identify, investigate, and solve problems to ensure operational success
  • Responsible to own, write, and close deviation investigations, change controls and CAPA’s on time
  • Develop and coach all direct reports to perform at the best of their abilities
  • Develop strong working relationships with peers and support groups that enhances team communication and collaboration

What you have to offer
Requirements:

  • Bachelor’s/Master’s Degree in Life Sciences or Engineering with a minimum 5 years of people management experience, or an associate degree (in any field) with minimum 8 years of people management experience
  • Minimum of 7 years’ progressive manufacturing experience in a pharmaceutical or biologics operation
  • Demonstrated ability to coach, develop, and hold team members accountable for their performance
  • Advanced knowledge of FDA and Annex 1 regulatory guidelines
  • Demonstrated experience interacting with regulatory agencies
  • Must possess high energy and a positive attitude to promote BioNTech’s Core Values
  • Experience in technology transfers and clinical/commercial manufacturing production
  • Ability to work different shifts and weekends as the business requires
  • Must have the ability to work, aseptically gown, and wear PPE as required per procedures in all cleanroom environments, such as, Grade D, Grade C, Grade B, and Grade A.
  • Be able to push, pull, and lift 50lbs.

Preferred Requirements:

  • 3 years of Cell Therapy experience
  • Subject matter expert in Aseptic processing
  • Experience leading teams in a cell therapy environment
  • Experience using any MES (i.e. PASX, Siemens)
  • Advanced skills in Microsoft Office Suite, SAP, and LIMS

#LI-EJ1

 


Benefits for you:

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
  • 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 – could be convinced to use the word “competitive.”
  • Tuition Reimbursement & Student Loan Assistance Programs
  • Wellbeing Incentive Platforms & Incentives
  • Professional Development Programs
  • Commuting Allowance and subsidized parking
  • Discounted Home, Auto & Pet Insurance (consolidate)

…and more! More details to be shared.

Have we kindled your pioneering spirit?

 

Then apply now for our location Gaithersburg  and simply send us your application documents using our online form.

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BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com