Manufacturing Research Associate

5 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**:
We are seeking a motivated, dynamic, solutions-focused, and creative individual to join our Product Support Team. The Manufacturing Research Associate is responsible for supporting the manufacturing of Response Biomedical products with the understanding that these products are used to aid in the 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, 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 as required.
- 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. May work on independent projects.
- Participates in the design and conducts research and experiments based on the needs of a group effort coordinated by a Supervisor, Manager, or others as required. This may include feasibility investigations, development work, verification activities, stability studies, and troubleshooting experiments.
- Develops, executes, and maintains product stability studies to support changes to processes, equipment, and raw material for field products.

**Teamwork and Communication**
- Presents data at team meetings and may present data 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.
- Provides oversight and leadership to Assistants within assigned projects and teams.

**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.

**Laboratory Administration**
- Performs, 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.

**Education, Work Experience, Knowledge, and Skills**:
**Formal Education**

Post Secondary Education or Degree in Biochemistry, Biology, Medical Technology, or Related Science

**Work Experience**
- 2 years of relevant work experience or equivalent combination of education and experience.
- At least 2 years of laboratory experience.
- Previous experience in a medical device or pharmaceutical development environment is an asset.

**Skills & Knowledge**
- Strong scientific writing skills and experience crea

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