Product Development Scientist
- Req No.
- Job Locations
- Research & Development
More information about this job
The Product Development Scientist will play an active role in developing high-quality Fluidigm reagents. The individual will participate in exciting interdisciplinary team projects at the reagent product development and validation phases prior to product introduction.
Core Job Responsibilities:
- Write application, product or system validation test plans to support suspension (Helios) and imaging (Hyperion) platforms
- Working with product managers and product applications group, develop external test site plans
- Ensure that all validation tests plans are in concordance with customer and product requirements
- Working within cross-functional teams, perform or co-ordinate the execution of complex test plans
- Perform data analysis, prepare technical reports and present at technical reviews
- Support the documentation and quality activities related to design control
- Independent technical leadership and decision making for scientific methods
- Gain understanding of research practices, test methods, industry benchmarks and applies to the development of test plans and protocols
- Maintain records and laboratory environment to comply with regulatory requirements (eg. ISO 13485), good laboratory practices, and standard operating procedures.
- Provide technical guidance for development of manufacturing and QC documentation, as well as transfer QC processes to manufacturing operations
Education and Experience
- Require an advanced degree in Immunology, Molecular Biology, Biochemistry or Pathology, with a minimum of 1 year of related experience in flow cytometry, mass cytometry and/or microscopy; PhD is preferred.
- Experience in analytical /bioanalytical development and/or work in pharma R&D is desirable.
- Demonstrated ability for understanding research lab work, independent thinking, problem-solving skills, collaborative attitude within and outside own discipline and departments, and ability to manage multiple projects or assignments.
- Ability to read, analyze, and interpret scientific and technical reports, technical procedures, validation protocols and reports, operating instructions, scientific publications, general business periodicals, and/or governmental regulations.
- Attention to detail is essential.
- Ability to pick up new technologies quickly and troubleshoot independently.
- Ability to multitask in a fast-paced environment
- Ability to present and communicate (oral and written) information in a transparent manner.
- Familiarity with Design Control, ISO13485 and/or regulatory environment is an asset.
- Proficiency with Microsoft Office, including Word, Excel, and Powerpoint.
- Travel required - less than 10%.
- Ability to relocate to the Greater Toronto Area in Ontario, Canada.
The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer.