Scientist I, Formulation Development (Cryopreservation)

BlueRock Therapeutics is looking for a scientist who is self-motivated, innovative, and results-oriented to participate in the development of cryopreservation procedures and methodologies for various iPSC-derived cell therapy products and intermediates. The candidate will primarily work on establishing development tools including cryopreservation formulations and closed automated fill & finish solutions. This role, will utilize cutting-edge technologies and precise analytical techniques to optimize processes, confirm product integrity, and develop product understanding. The candidate will be part of a cross-functional matrix and work closely with Process Development and other internal partner functions including Research, Analytical Development, Quality Control, Manufacturing, and Quality.

This role is based in Toronto, ON (M5G 1L7).

Responsibilities:

• Design, execute, and interpret cryoformulation and fill/finish development experiments in collaboration with other team members, utilizing fundamental cryobiology and first principles.
• Evaluate and integrate cutting-edge technologies into the cellular therapy cryopreservation process. Identify meaningful process parameters (i.e. ranges and impact on quality attributes) while applying suitable analytics for enhanced efficiency and effectiveness.
• Perform technology transfer of the cryopreservation process to cGMP-compliant manufacturing facilities within the company or to CDMO partners.
• Prepare experimental proposals, standard operating procedures,technical protocols, and reports while interacting in a cross-functional environment.
• Analyze and document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system.
• Prepare and present scientific data in internal and external forums.
• Train and supervise staff members in supporting cryopreservation-related activities.
  
  

Minimum Requirements:

• Ph.D or MSc. degree in a Biological Science, such as Biochemistry, Immunology, Molecular Biology, or similar
• MSc. 9 / PhD 0-2 years of experience, preferably in an industry setting
• Hands on expertise in developing cryopreservation processes and broad knowledge in cryobiology are required.
• Understanding and experience of molecular techniques such as cell imaging, flow cytometry, or qPCR and ddPCR is required.
• Experience with data processing and statistical analysis software toolsis required. Practical knowledge of experimental design (e.g., DoE) is desired.
• Ability to plan experiments and independently execute complex tasks.
• Strong English written and verbal communications skills.
• Proficiency in technical scientific writing.
• Ability to work in a fast-changing environment.
• Collaborative team player.