CARREERS

Scientist QC and Method Development

Job Description

Biodextris is currently seeking to fill a Scientist position. The incumbent will be responsible for the development, validation, execution and transfer of complex analytical methods for internal or external client projects. This position is laboratory-focused, and excellent interpersonal skills are a requirement.

Specific Responsibilities

  • Independent execution of complex laboratory analysis of biologic or pharmaceutical products.
  • Proficient operation of a variety of analytical techniques and instrumentation, e.g. HPLC, UV-Vis Spectrophotometry, DLS, SDS-PAGE, Western Blot, Mass Spectrometry, SRID, ELISA.
  • Documentation and electronic data recording in adherence with Biodextris Quality Management System (QMS) and relevant regulatory guidelines (e.g. GLP, GMP).
  • Execution and documentation of Quality Control (QC) testing in a GMP environment.
  • Authoring of QMS documentation, such as method/equipment Standard Operation Procedures (SOP’s), validation protocols.
  • Execution and documentation of method/equipment validation activities in compliance with relevant regulatory guidelines.
  • Support or contribute scientifically to method development of analytical methods for the biophysical, physicochemical and immunogenic characterization of biologic or pharmaceutical products.
  • Support or contribute to compliance, maintenance and improvement of the Biodextris QMS.
  • Technical support and execution of method transfer from/to client or partner sites in compliance with relevant regulatory guidelines.
  • Support or independently evaluate and implement new technologies and development of novel analytical techniques.
  • Routine interaction with senior/project scientist(s) across multiple projects.
  • May provide training and technical leadership to less experienced staff.
  • May support or perform process (primary/secondary) development activities as necessary
  • Practice safe work habits and adhere to company safety procedures and guidelines.
  • Maintenance of accurate documentation of all work in appropriate formats.
  • Work with team members to manage assigned projects to establish priorities, set schedules, and monitor project progress.
  • Assist with troubleshooting laboratory instrumentation and other maintenance as required.
  • Ability to work a flexible schedule and adapt efficiently to program changes.
  • Perform all training activities necessary for the role, and maintain personal training file.

Required Education, Skills and Abilities

  • The candidate for this position is expected to have theoretical and practical scientific knowledge and experience typical of a Master’s degree level, for example:
    • Diplôme d’Études Collégiales (DEC) Biochemistry, Biological sciences or equivalent with 8+ years relevant experience.
    • B.Sc., Biochemistry, Biological sciences or equivalent with 5+ years relevant experience.
    • M.Sc., Biochemistry, Biological sciences or equivalent with 3+ years relevant experience.Technical knowledge and demonstrated experience in analytical method development.
  • Proficient in operation and troubleshooting of a wide variety of analytical instrumentation and data acquisition systems.
  • Theoretical knowledge in relevant scientific domains e.g. chemistry, biochemistry, molecular biology, immunology, microbiology.
  • Understanding and demonstrated experience working in compliance with cGMP requirements, ICH guidelines, USP requirements, FDA and EC guidance.
  • Ability to work independently and flexibly and to adapt to changing priorities.
  • Ability to cultivate a collaborative work environment with a team and across business areas
  • Ability to maintain clear and efficient method development documentation
  • Ability to follow scientific directions and work in a team
  • Ability to complete documentation per GMP (Good Manufacturing Practices) requirements
  • Effective written and oral communication skills as well as presentation skills
  • Proven analytical problem solving and troubleshooting abilities
  • Ability to manage multiple tasks and priorities for successful project completion.

 

Application: Please send resume and cover letter by email to info@biodextris.com.