Researchassociate Ii -Formulations

Research Associate II - FormulationsApex Systems is a large staffing and consulting firm and we are looking for a Formulation Scientist with a Chemistry/Biochemistry/Bioengineering background with and experience with formulation, in-vitro mammalian cell assays, and cell bioengineering to place at our Biopharma client. Client:
Innovative Biopharma clientContract/Perm &
duration:
12-month contract (potential for converting permanent)Location:
Downtown TorontoThe successful candidate will support development of cellular drug product formulations by identifying, designing and testing formulations to optimize cellular drug product in-use stability, cell dose delivery, and cell persistence after transplantation. The ideal candidate will be a highly motivated individual who has demonstrated strong bench skills, excellent documentation skills, attention to detail and enjoys working in a highly cross-functional environment.As a central development resource at the company, the Formulation Development team works closely with other product development teams to understand requirements and develop cellular drug product formulations for applications in therapeutic areas such as cardiology, neurology and immunology. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates.Responsibilities:
Support development of safe and efficacious injectable cellular medicines. Identify critical formulation parameters for optimal cellular drug product in-use stability, cell dose delivery, and cell persistence after transplantation.Act as technical contributor for formulation development and chemical, physical and biological characterization of formulations. Utilize state-of-the art techniques and technologies to develop and characterize formulations. Troubleshoot technical issues that are encountered during formulation development and tech transfer.Plan, design and execute formulation development experimental studies. Identify and determine appropriate ranges of experimental parameters to ensure robust, repeatable and accurate results. Ensure that experimental design, analytical methods and data meet the requirements for the intended use of the cellular medicine drug products. Collect, analyze, track and trend data and establish a basis for determining quality control specifications including critical process controls.Collaborate with Assay Development colleagues to support execution of cell-based assays for assessing new formulations. Collaborate with Translational Biology colleagues to enable assessment of new formulations in vivo. Collaborate with Device Development colleagues to enable device development and testing with new formulations.Interpret and communicate scientific data and recommendations. Document experimental data in electronic laboratory notebooks in a timely and accurate manner. Author and review SOPs, study protocols, reports and other required documents describing accomplished R&
D work in formulation area. Present scientific data internally and externally as needed.This position requires hands-on laboratory work. Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned. Key Qualifications:
MSc in Biomedical, Chemical, Material, Biological or Pharmaceutical Sciences or Engineering, and 1-3 years of formulation development experience in a biotechnology, pharmaceutical or medical device industry setting are required. Level on Scientist ladder commensurate with years of experience.Experience with formulation development, testing procedures and equipment for physical and chemical characterization of the formulations is required. Experience with injectable drug product formulations is a plus.Broad knowledge of molecular and cell-based in vitro assays is required.A solid understanding of aseptic techniques in cell culture is required.Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint) and statistical analysis software (such as GraphPad, Minitab) is required.Self-motivated and with a proven ability to be highly productive and successful in a fast-paced work environment, with excellent attention to details and meticulous bench work. Collaborating with a cross-functional team, must be able to solve a wide range of complex problems in creative and practical ways.Excellent interpersonal, verbal and written communication skills.