Downstream Process Scientist

Position Summary & role expectations:

Biodextris has an immediate opening for a Scientist in bioprocess development. The Scientist will be responsible for the independent design, planning and execution of complete upstream processes for R&D, non-GMP or GMP projects, depending on specific project scope and client requirements. 

The successful candidate must be flexible for working on multiple projects and highly creative and solution oriented to adapt to specific needs and requirements of the different clients.

The successful candidate is expected to have demonstrated expertise in the development and optimization of microbial and mammalian cell culture techniques for production of recombinant proteins and other biologics. This includes skills to operate in shake flasks, small scale system such as AMBR250, 5L stir tank, wave bags and 50L bioreactors.

The ideal candidate will play a leading role during several major project steps, including:

• When applies, design and develop end-to-end microbial, insect cells or mammalian culture processes in batch or fed batch mode, including cell or media harvest. Implementation of project-specific cell paste treatment, like ultrafiltration washes, heat/chemical inactivation, or others if necessary.
• Transfer of client’s technology during projects initiation and adaptation to the in-house systems.
• Process scaling up, use of process monitoring tools for data-driven identification of critical process parameters and product key quality characteristics.
• Identify and solve complex problems and technical and scientific creativity.
• Communicate project progression to internal and external stakeholders.
• Participate actively to technical transfer of the developed process to GMP manufacturing team by redaction of procedures, training of personnel and support during execution, as a subject matter expert (SME).

The position may imply the culture at small to large scale of biosafety level 2 organisms, depending on project scopes. Those activities are performed in certified installations using appropriate personal protection equipment.

Whereas the main area of expertise for this position must be related to upstream processes, the incumbent should possess knowledge and skills to participate actively and autonomously in a wide range of bioprocessing activities, including downstream purification, formulation, and analytical characterization.

Specific Responsibilities:

• Determine independently scientific/technical strategy, methods and procedures on new assignments in the field of expertise. May provide guidance to other personnel to accomplish Upstream processing development and project tasks.
• Autonomous planning and execution of project work in accordance with timelines
• Co-ordination of Upstream Processing activities in relation to other activities within the product development effort.
• Redaction of procedures, training of personnel and support to execution, as a subject matter expert (SME) during technical transfer of GMP manufacturing process
• Training and supervision of junior staff and internal project resources
• Providing written reports as required, including periodic progress reports, Development History reports, Quality Management System reports, and appropriate sections of regulatory filings, INDs, CTAs, etc.
• Maintenance of accurate documentation of all work in appropriate formats.
• Documentation and electronic data recording in adherence with Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines (e.g. GMP) where appropriate.
• Practice safe work habits and adheres to company safety procedures and guidelines.
  
  

Skills, Knowledge and Abilities:

• High level of initiative and adaptable to change. 
• Creativity; Result-oriented; Strong Problem-solving; Critical thinking; Performance awareness.
• Solves problems by integrating knowledge from several scientific/technical fields.
• Proficient in several technical/scientific fields, including outside of main expertise area.
• Theoretical expertise and demonstrated mastery within the field of microbial and mammalian cell culture technologies, media screening, bioreactor operation, etc. 
• Theoretical knowledge and functional experience in downstream protein and biologics process
• Technical knowledge of biotherapeutic and vaccine development, testing and production. 
• Knowledge of the drug/biologic development cycle, regulatory pathway and relevant compliance standards for biotechnology products, vaccines, or biopharmaceuticals. 
• Ability to co-ordinate activities within multi-disciplinary technical teams. 
• Ability to work well with cross-functional teams and diverse groups of stakeholders. 
• Strong organizational skills, including attention to detail and ability to meet deadlines. 
• Ability to work well independently as well as effectively in a team environment. 
• Excellent written, verbal communication and effective interpersonal skills. 
• Ability to build credibility and trust. 
  
  

ACKNOWLEDGEMENT AND AGREEMENT

Education and Experience Requirements:

• Degree in biochemistry, Chemical/Process engineering, Microbiology, or related field with a minimum of 5 years of related experience.
• Or equivalent combined education with relevant work experience.
• Experience acquired during internships M.Sc are considered in the evaluation of the amount of related experience.