Bioanalytical Scientist & Project Manager

Location: Malmö
Reports to: Directors of Bioanalytical Services 
Last day of application: 2019-09-30. Please apply as soon as possible as we are working continuously with the applications.

Our Bioanalytical Scientists are critical for our bioanalytical contract laboratory and act as Project Managers for our projects with pharma and biotech clients. You now have the opportunity to become part of a dedicated team in a fast-growing company that assists in pushing the boundaries of innovation.

As a Swedish bioanalytical CRO we aim to work in a tight collaboration with our clients by establishing a trustful relationship and hereby you will have a significant involvement in our clients’ drug development programs.

The successful candidate will enjoy working in a dynamic and everchanging environment where you will be the driver to deliver Bioanalytical and Immunogenicity high quality data for our client’s decision-making process for ground-breaking new drug candidates. The position involves daily project management and the work is governed by ISO15189, GLP and GCP as well as bioanalytical guidelines.

Download Job Description - Bioanalytical Scientist & Project Manager

Contact
For questions, please contact Directors of Bioanalytical Services, Anna Laurén, +46 702743482 or Janka Ryding +46 702718956

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ABOUT YOU

You have a Life Science academic PhD degree, or similar work experience and have a minimum of 3-5 years’ experience from the life science industry. The role demands a Project Manager mindset and high attention to details and stakeholder management.

You are familiar with EMA/FDA Bioanalysis and Immunogenicity guidelines as well as the GLP and GCP directives and Experience with ligand-binding assay development and validation within a wide range of relevant technology types e.g. MSD, ELISA, RIA and cell-based assays. 

Use of IT systems is something that comes natural to you and you have strong written and oral communication skills. To fit and complement the team you are flexible, ambitious and structured with a strong focus on results and acknowledge that delivery of timely data to our clients is crucial!

You will be the Study Director/Principal Scientist for Sponsor studies and the Project Manager and point of contact for the Sponsor. You will collaborate with- and supervise laboratory technicians and laboratory scientists. You are responsible for planning, development and validation of bioanalytical assays according to current guidelines.

Responsibilities include, but are not limited to:

  • Apply GLP and GCP quality principles to daily work
  • Write/review bioanalytical methods SOPs, plans and reports
  • Collaborate with relevant functions in the proposal generation and work order management process
  • Ensure timely execution of agreed project timelines
  • Responsible for acceptable study compliance according to current guidelines.
  • Responsible for contract payment milestone tracking and project progress communication to management
  • Write/review applicable documentation in the Quality Management System
  • Participating in projects as quality representative, ensuring on-time delivery of on-budget projects with a high degree of user satisfaction and quality