Manager/ Associate Director* Biomarker Operations

  • Cambridge, Massachusetts
  • Mainz
  • Work experience
  • Project Management, Product Management
  • Research, development, teaching
  • Published: 04.01.2022
scheme imagescheme imagescheme image

Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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.

Manager* Biomarker Operations

At BioNTech, you will be responsible for the efficient management of the lifecycle of biomarker samples in global phase l-lV clinical trials. Your main responsibilities are:
  • Execute biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples in projects with high complexity, as across continents
  • Manage cross-functional integration and execution of operational biomarker elements and ensure meeting deliverables in time and quality (including ICH/GCP regulations)
  • Build and maintain efficient biomarker sample analysis & data delivery processes
  • Establish and ensure accurate tracking and reporting of biomarker sample and data metrics 
  • Day-to-day operational routine management of biomarker vendors
  • Mentoring responsibilities for junior team members 

What you have to offer.

Professional Training / Academic degree
  • Vocational training (biology/chemistry/molecular biology) or comparable studies in the natural sciences (Bachelor) with 4+ years of experience in clinical operations or Master’s degree in Biology, Pharmaceuticals or other Science discipline with 1+ years of experience in clinical operations or PhD in Biology, Pharmaceuticals or other Science discipline
  • Experienced in working within interdisciplinary cross-functional program teams in a matrix environment
  • Hands-on experience in GxP (GLP, GMP, GCP) regulated laboratory environment and a certification in clinical research (eg, ICH/GCP- or CRA training) would be appreciated
  • Strong communication, organization and coordination skills
  • Experience in CRO/vendor management
  • Excellent, targeted communication and expert stakeholder management, Fluent in English and any other language is a plus
  • Project Management experience
  • Proficient in the use of MS Office software
Professional Experience
  • Minimum of 4 years’ experience in central laboratory operations, study start up (lab manual, requisition forms), clinical sample (eg, Biomarker, PK/PD) tracking/reconciliation and analysis
  • Proven experience with GCP environment and Lab Management System (eg, LIMS)
  • Proven knowledge in Therapeutic areas like Oncology, Immuno-oncology or Infectious Diseases
  • Proven track records of independent contributions to global clinical studies and clinical operations (e.g. in CRO, biotech/pharmaceutical companies and/or central labs) would be a plus
 

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

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

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm). #LI-DCA

Job-ID 5274 (please indicate for inquiries)

We look forward to your application!

*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!

BioNTech - As unique as you

https://biontech.de