Analytical Development Scientist - Microbiology

Analytical Development Scientist – Microbiology (f/m/d) 100%. Hørsholm, DK.

Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

We are looking for a Scientist with a strong background in microbiology and analytical development to join our Analytics team located in Hørsholm, Denmark. The Analytics team is primarily responsible for developing of QC release methods according to relevant requirements supporting our customer projects. Additionally, the team is responsible for development and transfer of new analytical methods.

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Analytical Development Scientist – Microbiology

My main tasks will be…

  • Design, plan and execute analytical development activities, compliant with GMP systems while adapting scope of work and requirement depending on the assay type (compendial, off-the-shelf or specific).
  • Development of methods include:
    • Microbiology methods used for bacterial enumeration (CFU, MPN, flow cytometry, qPCR), for bioburden contaminant testing and genotypic and phenotypic identification of microbes.
    • assays which will be ultimately used at QC for release or ICH stability testing, and as such require tech transfer to QC.
    • assays used to characterize the product, for information only, where development scope will be more limited.
    • assays development to support process development activities.
  • Act as a technical lead for Analytics representing the team in a matrix environment, both internally within project team, and externally with customer.
  • Report results and prepare necessary tech transfer related documents and tasks to support method tech transfer activities with QC.
  • Present results both internally to the team and relevant stakeholders, and externally to customers.
  • Coordinate analytics testing for Engineering testing and initial non GMP stability study; review and report results and present them whenever relevant.
  • Drive continuous efforts to improve and expend Bacthera’s analytical offering services to match current and future customer needs.
  • Active surveillance of pharmacopeia and any relevant guidelines for LBP focusing on analytics.

I bring with me…

  • MSc degree in Microbiology or a life science-related field of study 3+ years of experience in an industrial setting
  • Experience with development of microbial analytical methods and demonstrated expertise in assay optimization and validation
  • Familiarity with Pharmacopeia, USP, FDA, ICH, and EU Regulations and Guidelines
  • Scientific curiosity, active and independent problem-solving capabilities.
  • Experienced in working within a quality-controlled environment, is a plus
  • Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
  • Experience with anaerobic microbes is an advantage
  • Excellent spoken and written English is required
  • Excellent communication and interpersonal skills; you enjoy working as part of a team and seeing projects through to completion
  • Ability and willingness to drive own projects is expected

My reasons for choosing Bacthera…

  • Innovative and fast-growing start-up company with short decision-making processes
  • Flexible working hours
  • Motivated, agile and multinational team
  • Interesting and diversified tasks

This is the opportunity to be part of a fast-growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to hear more about you.

Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms. Sandra Gamboni, Global Head of HR, hr@bacthera.com. Application deadline: 26th of August 2022.

We are looking forward to your application!