Quality Control Scientist

Longboat is seeking a Quality Control Scientist to perform Analytical testing.

Are you ready to join a team committed to moving cell therapies into clinical and commercial settings by supplying high quality neonatal amniotic GMP MSCs for cell therapy use? Longboat is at the start of an exciting journey, and we are looking for passionate individuals to join us on this important mission.

Longboat is a stem cell company, dedicated to developing and commercializing novel treatments for the benefit of patients suffering from rare and life-threatening airway diseases, and to supply high quality amniotic Mesenchymal Stem Cells (MSCs) to universities, hospitals, the biotech industry, and clinical-stage pharmaceutical companies for other indications.

Longboat is seeking a Quality Control Scientist to perform Analytical testing in our new research and clinical production facility located in Lund. The Scientist within the QC group will have an overall responsibility, among others, of providing technical expertise for the execution of analytical test methods, supporting method transfer, promoting a culture of quality and compliance and assisting in improving quality metrics within QC.

He/She will be responsible for Quality Control (QC) testing of in-process and final product. The position will report to the Head of Quality and will contribute to the development of QC departmental processes. All in all, Longboat envisions to be a team of ca. 15 people in a year’s time.

Responsibilities

  • Support activities related to the transfer and validation of analytical methods.
  • Perform routine in-process and release QC testing of cell products.
  • Execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and troubleshooting.
  • Maintain, calibrate and operate equipment and instruments supporting Flow Cytometry.
  • Track and test products according to stability protocols.
  • Monitor and trend QC data.
  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations and CAPAs related to analytical procedures.
  • Perform QC lab duties and technical projects as required.

Qualifications

  • Minimum BS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. MS or PhD preferred.
  • Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, Real-Time PCR, ELISA, Cell Viability measurement, etc.
  • Experience in performing analytical method validation and supporting method transfer activities.

Preferred

  • Experience in QC department in the biotech and/or pharmaceutical industry.
  • Knowledge of GMP, SOP's and quality control process.
  • Excellent oral and written communication skills. Strong technical writing ability.
  • Experience with cell therapy manufacturing a plus.

Please note this job description is not an exhaustive listing of activities, duties or responsibilities for this job. Duties, responsibilities and activities may change over time.

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