Scientist II - Analytical Development and Transfer

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 www.resilience.com

JOB SUMMARY:

• Transfers in, evaluates, 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.
• Designs and authors method feasibility workplans, method validation transfer protocols, 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.
• Trains Quality Control staff on new methods to be transferred to the Quality Control unit to be qualified for production run release testing.
• 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.

MAJOR RESPONSIBILITIES:

• Conducts the transfer, development, 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, scientific interpretations, 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.
• Works with clients as needed to transfer, optimize and/or develop analytical methods as needed
• 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.
• Continuous improvement: Evaluates new equipment and techniques related to protein analysis; provides recommendations for change and/or purchase
• 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

• Hands-on experience in development and execution of bioanalytical techniques for protein therapeutics
• Experience in R&D and Quality Lab environments
• Knowledge of compendial test requirements, US and Europe Pharmacopeia
• Experience in transfer, verification and validation of analytical methods used for in-process, release and stability testing of biopharmaceutical products
• Experience writing experimental and GMP documents in accordance with departmental and company Quality Standards
• Knowledge and practical experience in protein analysis such as ELISA, HPLC, 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 5 years’ industry experience in protein bioanalysis; M.Sc. with 7 years’ experience; B.Sc. with 10 years’ experience
• Protein chemistry; protein characterization; bioanalytical methods
• GDP compliant analytical methods and record keeping as appropriate for R&D and GMP manufacturing
• Knowledge and practical experience in protein analysis such as BCA, Western blot, Bradford, SDS-PAGE, CE-SDS, cIEF, Potency and Functionality Cell Based assays

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:

Demonstrated ability to apply the following behavioral competencies on the job:

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.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $90,000.00 - $131,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.