Scientist II

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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.

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Position Summary & Responsibilities

JOB SUMMARY :

The Scientist II (Upstream Processing) is a technical expert who will support upstream mammalian cell culture process development in support of manufacturing projects for biopharmaceutical products at RBI.

The current role requires leading the design, development, and establishment of scientifically sound cell line development and upstream bioprocessing (bioreactor production) methods for the manufacturing of recombinant biopharmaceutical products. The position involves technology transfer, process design and scale-up, cell bank generation, set-up and operation of seed trains and bioreactors, non-cGMP and cGMP document creation, and participation as subject matter experts in early-stage clinical production runs (non-cGMP and GMP).

The role also provides technical support, training, and troubleshooting to MSAT and Manufacturing Operations on matters related to cell cultures, seed trains, bioreactor operations, and metabolite analysis. The position involves process optimization and characterization and requires good documentation practices and the reporting and communication of results.

The role requires the application of advanced expertise and techniques to design and establish scientifically sound, industry best practice, clinical-scale, cGMP compliant, upstream manufacturing processes.

MAJOR RESPONSIBILITIES:

Team leadership

• Conduct cell line development and upstream process development activities for mammalian cell culture manufacturing projects at RBI
• Ensure that all ongoing upstream activities meet the expected target dates and deliverables
• Train and supervise technical staff in methods and procedures
• Strengthen process and product knowledge
• Resource scheduling, task-tracking and client/vendor interaction

Technical leadership

• Maintain strong technical expertise in the full scope of therapeutic protein upstream development and manufacturing covering: cell line development (mammalian), cell culture in shake flasks and bioreactors, culture scale up, clarification (filtration and centrifugation) techniques, and associated analytics
• Prepare Process Designs, Outlines, Workplans, Batch Records, Reports and other required documents for process development and manufacturing work
• Participate in technology transfer activities from clients and internally to Manufacturing Operations
• Execute experiments, analyze data, and report results
• Identify, offer, and implement contingency plans to prevent and overcome issues; perform method troubleshooting; identify issues, solve problems and incorporate changes into ongoing development and production runs
• Participate in project team and client meetings; present plans and results as appropriate
• Manage outsourced services related to process characterization and testing as required
• Present results, recommendations and future plans to management and clients as required
• Lead and participate in project teams and interface with other departments when required (e.g., Manufacturing Operations, Quality Assurance, Validation)

Functional Responsibilities

• Maintain compliance with current Good Manufacturing Practices (cGMP) Regulatory standards
• Manage inventory control and tracking of material generated from processes
• Identify, review and recommend continuous quality improvements
• Recommend, acquire and maintain equipment suitable for current industry standard upstream processing
• Keep current on industry best practices, standards, and technology pertaining to cell line development and upstream process development and manufacturing instrumentation, analytical techniques, and equipment
• In areas of health, safety and environmental policies, contribute toward meeting departmental/company goals
  • Routine maintenance of cell lines, research cell banks (RCBs), master cell banks (MCBs) and working cell banks (WCBs); this includes the documentation review of client cell bank analytical testing prior to receipt at the facility

Minimum Qualifications

• A sound knowledge of upstream processing, including recombinant protein expression and cell culture techniques, at small, intermediate and large scale, as well as development of scale down models
• Deep understanding of cell line development, or molecular biology, and/or cell culture dynamics and growth
• Operational knowledge and hands-on experience with various upstream manufacturing equipment including incubators, bioreactors, and diagnostic instrumentation
• Excellent technical problem solver, critical thinker
• Works well independently and in a team environment
• Excellent written and verbal communication skills
  • Knowledge and experience with mammalian cell cultures; hands-on experience working with shake flasks and single-use bioreactors
  • Knowledge of scale-up strategies and equipment requirements
  • Data analysis and report preparation with knowledge of MS Word, Excel, PowerPoint and Outlook
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines

PREFERRED QUALIFICATIONS:

• Ph.D. or M.Sc. degree in Bioprocess/Biochemical Engineering, Microbiology, Cell Biology
• Minimum of 5 years (7 years if M.Sc.) of recent scientific and industrial experience in a biotechnology development and manufacturing environment
• Knowledge of aseptic techniques in a cGMP environment
• Knowledge of upstream-related analytical assays
• Working knowledge of production scale bioreactors

Preferred Qualifications

• Knowledge of aseptic techniques in a cGMP environment
• Knowledge of upstream-related analytical assays
• Working knowledge of production scale bioreactors

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.
• This position requires vaccination for Hepatitis A and B
• Job requires occasional shift work, weekends and extended shifts, with possible schedule shift changes on short notice

BEHAVIOURAL:

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

Problem Solving: Anticipating, analyzing, diagnosing and resolving problems in a manufacturing environment

Creativity/Innovation: Adapting traditional or devising new approaches, concepts, methods, models

Flexibility: Agility in adapting to change

Verbal Communication: Speaking succinctly and understandably

Decision Making: Utilizing effective processes to make decisions

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.

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