Principal Analysis Specialist at Bioneer A/S

Bioneer A/S is seeking a skilled Principal Analysis Specialist to join our team. If you have a passion for analytical sciences and a drive to support innovative projects in the life science industry, we want to hear from you.

About Bioneer

Bioneer A/S is a trusted strategic partner to a broad range of biotech and pharmaceutical companies in Denmark and internationally. We create customized and innovative research and manufacturing service solutions that help companies to develop and produce recombinant proteins and to generate key pre-clinical insights into the mechanisms, efficacy, safety, and delivery of their early drug candidates. Operating from state-of-the-art laboratories Bioneer brings expert insights, speed & quality to the Danish and international Life Science industry.

Our Contract Development and Manufacturing Organization (CDMO) provides small scale but high- end process development and cGMP manufacturing services in the specialty protein/enzyme area. The CDMO works closely together with the Recombinant Protein group in the CRO when developing, implementing, or trouble shooting new manufacturing processes.

Our Contract Research Organization (CRO) provides R&D based services within the biomedical and biotechnology field. Services include end-to-end recombinant protein solutions from feasibility to non-GMP production and early drug candidate development, characterization, and formulation.

About the position

As a Principal Analysis Specialist, you will join our growing CDMO department of approx. 15 employees located in Hørsholm.

Your responsibilities will among others comprise

  • further develop and maintain Bioneer’s analytical platform, including both cGMP and GLP
  • ensuring that analytical equipment and methods support Bioneer’s projects and overall
  • ensuring that Bioneer internal analytical protocols and validations (e.g. Bioburden, Endotoxin) meet all relevant requirements (GxP, USP).
  • ensuring successful tech-transfer of analytical technologies and methods from clients.
  • support robust and scalable process developments with the development/implementation of relevant IPC and release analyses in collaboration with CDMO Project Managers, Scientists, and
  • assisting projects with specialist analytical support and participate in project meetings focused on analytical deliverables and/or
  • supervising a small team of laboratory technicians in the practical execution of
  • participating in optimizing the CDMO department to handle future projects, including establishing standard change-over analysis procedures and validations for selected manufacturing
  • supporting the CDMO management in planning and designing a QC laboratory for a future manufacturing

 

About You

You have a relevant life science education at the M.Sc. or Ph.D. level and have significant industrial experience in analytical sciences, ideally from the biotech or pharmaceutical industry. You are a responsible, flexible, and highly motivated team player with commitment, initiative, and a sense of humor.

Our preferred candidate has:

  • Experience from a manufacturing
  • Broad experience with a number of state-of-the-art analytical instruments and methods
  • Documented experience with developing and writing cGMP compliant analytical procedures, validation protocols, and
  • A quality mindset and the ability to lead, plan, and execute on analytical tasks.
  • Excellent collaboration, communication, and writing skills and are adept at leading and motivating technicians and fellow scientists.

Why Join Bioneer

We offer an exciting job in a dynamic and growing company where you can help set the direction for our analytical capabilities. We strive to make Bioneer an interesting workplace and can offer exciting work challenges and development opportunities in an informal and collaborative climate. Explore more about Bioneer at www.bioneer.dk.

Application

Please send your application marked ‘Principal Analyses Specialist’ by email to bioneer@bioneer.dk no later than 30-Aug-2024. Applications will be evaluated on an ongoing basis, so we encourage you to apply as soon as possible.

For further information, please contact Jens Chr. Norrild, Ph.D, Chief CDMO Officer (CCO) at  jcn@bioneer.dk; +45 3045 1063.

We look forward to welcoming the right candidate to our team!