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The Scientist II (Molecular and Cellular Biology) is a technical expert who will lead cell line development in support of manufacturing projects for biopharmaceutical products at RBI.

The current role requires leading the design, engineering, and optimization of mammalian cell lines for the production and manufacturing of recombinant biopharmaceutical therapeutic proteins (e.g., monoclonal antibodies, bispecific antibodies, fusion proteins). The position involves designing and preparing expression vector constructs (DNA plasmids); incorporation of genetic constructs into host cells (e.g., transfection; CHO cells); selection and creation of stable clonal pools; clone screening and selection; research cell bank (RCB) generation and characterization, cell line stability and characterization.

The role also provides technical support, training, and troubleshooting to MSAT and Manufacturing Operations on matters related to master cell bank (MCB) and working cell bank (WCB) testing and characterization. The Scientist II would work closely with third party cell line and/or vector providers as well as with clients in the design and characterization of all aspects of cell line development. The position requires good documentation practices and routine reporting and communication of results, both internally as well as to clients.

The role requires the application of advanced expertise and techniques to design and establish well-characterized, industry best practice, cGMP compliant, manufacturing clonal cell lines.

MAJOR RESPONSIBILITIES:

Team leadership

• Conduct cell line development activities for mammalian cell culture manufacturing projects at RBI
• Ensure that all ongoing cell line development 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

2. Technical leadership

• Maintain strong technical expertise in the full scope of therapeutic protein cell line development covering vector construction (DNA plasmids), transfection (or other means) into host cell line, clone generation, screening and selection (imaging), cell line stability (genetic) and characterization (sequencing), and associated analytics (titer, growth characteristics, metabolites analysis, etc.)
• Prepare Process Designs, Outlines, Workplans, Batch Records, Reports and other required documents for process development work
• Participate in technology transfer activities from clients
• 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 experiments
• Participate in project team and client meetings; present plans and results as appropriate
• Manage outsourced services related to cell line/clone 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)

Functional Responsibilities

• Manage inventory control and tracking of material generated from processes
• Familiar and compliance with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP)
• Identify, review and recommend continuous quality improvements
• Recommend, acquire and maintain equipment suitable for current industry standard cell line development work
• Keep current on industry best practices, standards, and technology pertaining to cell line development instrumentation, analytical techniques, and equipment
• In areas of health, safety and environmental policies, contribute toward meeting departmental/company goals
• Routine maintenance of cell lines, RCBs; support maintenance of MCBs and WCBs; this includes the documentation review of client cell bank analytical and safety testing prior to receipt at RBI's facility

MINIMUM QUALIFICATIONS:

• Deep knowledge of recombinant protein expression, molecular and cell biology, cell line development and characterization
• Expert at cell culture techniques with small (shake flask)
• Operational knowledge and hands-on experience with various cell line development instrumentation, e.g., Solentim VIPS, Cell Metric, Octet, CEDEX, BPFlex, Ambr250
• 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
• Knowledge of aseptic techniques
• Excellent technical problem solver, critical thinker
• Works well independently and in a team environment
• Excellent written and verbal communication skills

PREFERRED QUALIFICATIONS:

• Ph.D. or M.Sc. degree in Molecular Biology, Cell Biology, Biochemical Engineering
• Minimum of 5 years (7 years if M.Sc.) of recent scientific and industrial experience in a biotechnology development and manufacturing environment
• Knowledge and experience with routine biologics analytical testing: HPLC, CE-SDS, ELISA, plate-based assays
• Expert at cell culture techniques with bench scale (bioreactors)

ADDITIONAL REQUIREMENTS:

• 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 behavioural competencies on the job:

Problem Solving: Anticipating, analysing, 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 work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This position may also include the following conditions: [insert options from job description template] 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 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, paid vacation, 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? We encourage you to apply and start a conversation with one of our recruiters.