Manufacturing Research Associate Scientist

2 weeks 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 total cost of care.

Who we are looking for?

We are seeking for a dynamic Manufacturing Research Associate Scientist who is self-motivated and enjoys working in a fast paced environment. This position is responsible for supporting the manufacturing of Response Biomedical products with the understanding that these products are used to aid in diagnosis of potentially life-threatening diseases. This role leads and supports scale-up, verification, and validation activities, transfer of new raw materials or products to manufacturing, technical troubleshooting of existing products/processes, and process improvement initiatives.

Key Responsibilities:

- Scientific Acumen and Product Support_
- Utilizes knowledge of basic scientific principles to assess experimental and operational responsibilities.
- Demonstrates technical proficiency, scientific creativity, effective collaboration with others, and ability to work independently.
- Participates in and leads investigations including troubleshooting, root cause analysis, and brainstorming sessions.
- Critically analyzes, summarizes, and reports data generated from experiments performed, draws conclusions from experimental findings, and recommends 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 needs. Will work on and lead independent projects.
- Leads and coordinates the design of research and experiments based on the needs of a group coordinated by a Supervisor, Manager, or others as required. This may include feasibility investigations, development work, verification activities, stability studies, and troubleshooting investigations.
- Develops and oversees product stability studies to support changes to processes, equipment, and raw material for field products.
- Continuously reviews non-conformances data to identify trends in product performance and initiates Corrective and Preventative Actions as required to reduce re-occurrence of non-conformities.
- Teamwork & Communication_
- Trains and empowers team members to provide technical guidance to support manufacturing and performance of existing products.
- Direct supervision of Associates and/or Assistants including performance management and training to meet all required standards and department needs.
- Presents data at team meetings and to interdepartmental groups.
- Creates and/or reviews product/process documentation including Standard Operating Procedures, Manufacturing Records and Forms, Protocols, Technical Reports, etc.
- Complies with the Company’s training plans and requirements. Trains or coordinates the training of others in laboratory processes, procedures, and in the design, execution and analysis of experiments as required. May oversee and train others in the execution of scientific research/development experiments.
- Quality Systems_
- Complies with the requirements working in a regulated environment under the guidelines set by the Company to assure compliance with the Medical Device Single Audit (MDSAP) regulations, ISO13485, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Design Control and Workers Safety.
- Maintains appropriate laboratory records, notebooks, and Quality Control and Manufacturing documentation as required.
- Ensures adherence to Standard Operating Procedures and Work Instructions and supports CAPAs, VRs, and NCs in accordance with the QMS.
- Assists with investigations and root cause analyses (OOSs, NCRs, CCRs, VRs) to support manufacturing troubleshooting and/or complaint handling.
- Administration_
- Oversees and delegates 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.
- _May participate in interview and selection of new hires._

Education, Work Experience, Knowledge, and Skills:

- Formal Education_

Post Secondary Education or Degree in Bioche

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