Research Associate Ii, Analytical

1 week ago


Mississauga, Canada Resilience Full time

A career at Resilience is more than just a job - it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit Position Summary: - Optimizes and establishes bioanalytical methods for protein production and purification.- Performs laboratory work supporting bioanalysis and characterization of process development experiments and early-stage clinical development production/manufacturing runs.- Works with RBI’s Quality Control unit supporting analytical method feasibility and phase-appropriate validation (method qualification) of release testing assays.- Authors method feasibility workplans and method qualification protocols; executes the workplans/protocols in the Development lab or in RBI’s Quality Control laboratory as needed/appropriate; helps in troubleshooting any challenges during the execution; authors reports and method SOPs/WINs.- Conducts analytical testing/development work in small teams or individually as required.- Prepares comprehensive and complete documentation; conducts thorough analysis of data; reports results for all work completed.- Conducts high-quality work in accordance with all required safety standards and Regulatory guidelines where applicable.- Completes experimental work/written documents etc. in a timely manner according to project timelines. Responsibilities: - Conducts the transfer, development, and qualification/validation of analytical methods in coordination with Quality Control and Quality Assurance, as required.- Prepares workplans, protocols, records, and reports.- Presents results, recommendations and next steps for projects to clients and management.- Prepares written reports of results, analyses, and summaries of work.- Prepares laboratory methods and procedures, SOPs/WINs and executes work at the appropriate level of compliance for non-GMP and GMP projects as required.- Coordinates external testing with vendors or other labs in the RESILIENCE network as required- Participates in project team meetings and works on multiple projects as required.- Maintains up to date technical and compliance training.- Ensures all required materials to perform work are available and maintained.- Ensures all required equipment and devices are maintained and calibrated appropriately. Minimum Qualifications- Knowledge and/or practical experience in protein analysis such as HPLC, LC-MS, GC-MS, BCA, Bradford, ELISA, cIEF, SDS-PAGE, Western blot, and concentration analysis using UV-Vis Spectrophotometry.- Good written and verbal communication skills- Works well independently and in a team environment- Able to keep meticulous laboratory records Preferred Qualifications- Ph.D. with > 1-2 years industry experience; M.Sc. with 5 years’ experience- Experience in R&D or Quality Lab environments- Experience writing experimental and/or GMP documents in accordance with departmental and company Quality Standards- Protein chemistry; protein characterization; bioanalytical methods- Hands-on experience in development and execution of bioanalytical techniques for protein therapeutics- GDP compliant analytical methods and record keeping as appropriate for R&D and GMP manufacturing This position may also include the following conditions: - Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE’s SOPs; included as part of the medical is a respirator fit test (half mask), and pulmonary function test - This position requires vaccination for Hepatitis A and B BEHAVIOURAL: - Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective- Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives- Written Communication: Writing clearly, succinctly, and understandably- Creativity/Innovation: Adapting traditional or devising new approaches, concepts, methods, models- Problem Solving: Anticipating, analyzing, diagnosing and resolving problems- Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.- Flexibility: Agility in adapting to change. Ability to work independently. Occasional weekend/evening work required. Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.


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