Product Development Scientist

6 months ago

Vancouver, Canada Response Biomedical Full time

**Who we are**:
Response Biomedical Corp. has been transforming acute care diagnostic testing, with the central focus on improving patient outcomes and healthcare reform for over 20 years. Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business. We believe the people we work with including our partners, medical teams, and employees are the cornerstone of our success.

**What we do**:
Our RAMP platform is a global leader in diagnostic testing solutions for use in cardiovascular, infectious disease, sepsis, women’s health, arbovirus, and biodefense. We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to collaborating with the teams that are dedicated to saving lives. We do this by providing lab-quality results within minutes that medical teams can trust while reducing the total cost of care.

**Who we are looking for**:
**Key Responsibilities**:
**Scientific Acumen**
- Applies broad knowledge of current scientific principles and theories to the design, development, and execution of scientific research and development of new assays or related projects independently or in collaboration with a project team.
- Demonstrates technical proficiency, scientific creativity, effective collaboration with others, and ability to work independently.
- Demonstrates clear understanding of and applies the principles, requirements, and practices of Design Control. Manages technical aspects of development projects as required.
- Critically analyzes, summarizes, and reports data generated from experiments performed, draws conclusions from experimental findings, and recommends and executes required follow-up actions with consideration of prior experimental findings (self and others). Proposes new studies or investigations based on findings and efforts in relation to project objectives and timelines.
- Provides leadership in the design and realization of research, tasks and experiments based on the needs of a group effort. This may include feasibility investigations, development work, verification activities, stability studies, and troubleshooting experiments.

**Regulated Environment**
- Complies with the requirements of working in a regulated environment under the guidelines set by the Company to assure adherence to its internal Quality Management System (QMS), various governmental requirements including Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Worker's Safety.
- Supports efforts to ensure all products under development meet pre-determined product specifications and all applicable requirements of the Food and Drug Administration (FDA), Quality Systems Regulations (QSR), Health Canada, and CE mark.

**Teamwork & Communication**
- Presents data at Team meetings and presents data to interdepartmental groups and to outside stakeholders. May represent the Company in external relationships that may include instrument manufacturers, suppliers of critical components and training, and customer support activities.
- Supports the timely transfer of Product Development processes for finished products and/or new processes to Manufacturing. Supports completion and release of documents for newly developed products/processes by ensuring all relevant technical information is incorporated into the Company's Standard Operation Procedures, Manufacturing Records and Forms, etc.
- Complies with the Company’s training plans and requirements. Develops training plans. Trains or coordinates the training of others in laboratory procedures and in the design, execution, and analysis of experiments as required. May oversee and train others in the execution of scientific research or development experiments.

**Administration**
- Direct supervision of Associate Scientists, Associates, and/or Assistants including technical guidance and training to meet all required standards and department needs.
- Takes a leadership role in general laboratory tasks such as reagent preparation, inventory, and laboratory clean up and organization.
- Assumes additional laboratory and departmental responsibilities as required. May perform other assignments and tasks as directed.
- Ensures the team maintains appropriate laboratory records, e-notebooks, and Quality Control and Manufacturing documentation as required.
- May participate in interview and selection of new hires.

**Education, Work Experience, Knowledge, and Skills**:
**Formal Education**:
Minimum requirements: M. Sc. or an equivalent combination of relevant education (post secondary education in Biochemistry, Biology, Medical Technology, or Related Science.) and work experience.

**Work Experience**:

- 5 years relevant work experience or equivalent combination of education and experience
- At least 3 years of laboratory experience is required.
- Previous experience in a medical device or pharmaceutical development environment is an asset.

**Skills and Knowled

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