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Associate Director, PK and Biomarker Bioanalysis

Shanghai, China   |   full time   |   Job ID: 8287 

 

 

As subject matter expert (SME) for PK and biomarker bioanalytics, you are responsible for delivering methods and data output for PK, ADA and biomarker analytics required for all phases of clinical trials, each outsourced to external contract laboratories.

 

Your main responsibilities are:

  • Collaborate with PK and translational scientists and relevant R&D teams to provide local support on scientific, technological, strategic, and regulatory guidance, with hands-on contributions to patient selection, biomarker and PK/ADA testing accompanying clinical trials to drive the company’s R&D programs.
  • Coordinating PK and biomarker related study activities with internal and external stakeholders and CROs.
  • Lead local selection and management of contractors/CROs as appropriate in terms of their technical appropriateness and compliance with the respective regulatory requirements
  • Responsibility for method transfer to or method development /validation at external vendors (contract labs)
  • Responsibility for oversight of contract laboratories that perform feasibility studies, (further) development, and appropriate analytical validation of methods
  • Be familiar with local regulations (e.g., HGR) to improve biosample management and China strategy with fully compliance.

 

What you have to offer:

  • Degree in chemistry, biology, biochemistry, pharmaceutics or related disciplines
  • A minimum of 7+ years of experience in regulated pharmaceutical or regulated biotech industry
  • Solid experience in assay development and analytical validation of methods for PK, ADA and biomarker testing or cell based biopotency assays
  • In-depth knowledge of GCP/GLP and/or GMP Quality Control as well as FDA and EMA requirements
  • Ability to express complex issues in concise and clear language, fluency in English (written and spoken)
  • Ability to identify problems and find solutions, as well as attention to detail

 

 

Your Benefits:

 

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

 

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

How to apply:

 

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

 

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your Recruiter.

 

We are looking forward receiving your application.

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BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!  

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