Senior Associate/Manager, Manufacturing Operations*

  • Cambridge, Massachusetts
  • Work experience
  • Research, development, teaching
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Senior Associate/Manager, Manufacturing Operations*

Become Part of the BioNTech Family.

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 manufacturing experience to join the BioNTech Technical Operations group.  The candidate will be responsible for supporting the coordination of the operations of BioNTech immunogen manufacturing contract manufacturing organizations.  The successful candidate will report to the Manager, Manufacturing Operations of Immunogens and work in close collaboration with the Process Development, Manufacturing, Supply Operations, Quality Control, Regulatory and Quality Assurance groups.




 

Here, you’ll achieve greatness.

Supporting BioNTech’s Technical Operations Group in the US by:
   
  • Support the coordination of the operational aspects of immunogen product manufacture for clinical supply of multiple programs in accordance with strict timelines
  • Review and approval of executed batch records
  • Data entry and utilization of statistical analysis software to trend clinical in-process data
  • Support management of meetings and communication with contract manufacturing organizations
  • Support tech transfer and process improvement projects
  • Support projects to improve cost of goods and turnaround time
  • Support commercial industrialization projects
  • Support vendor selection process including preparing request for proposals and selection reports
  • Participate and provide updates on immunogen manufacturing progress at CMC and/or staff meetings
  • Develop and manage annual objectives
  • Coordinate and manage manufacturing change controls, investigations, SOP development, and validations

What you have to offer.

  • Minimum requirements; 
  • BS or MS in Chemistry, Biology, Engineering or other Life Science with 4+ years of cGMP manufacturing experience
  • Experience in cGMP RNA or peptide manufacturing preferred
  • Experience in equipment qualification and/or process validation a plus
  • Experience working at or with cGMP contract manufacturing organizations a plus
  • Strong project management and organization skills
  • Experience with Microsoft Office suite including Word, Project, Excel, and Powerpoint
  • Experience with statistical analysis software and tools a plus
  • Experience in deviation investigation, root cause analysis, and CAPA a plus
  • Experience with authoring SOPs, engineering protocols, and batch records
  • Excellent communication and collaboration skills
  • Ability to lead and work within cross-functional teams
  • Attention to detail and highly organized

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

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