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

The current role requires leading the design, engineering, optimization of mammalian cell lines and upstream bioprocessing (bioreactor production) methods for the production and manufacturing of recombinant biopharmaceutical therapeutic proteins.

The position involves technology transfer; generation of expression vector constructs to research cell bank (RCB) generation and characterization with support from third party providers; upstream process design and scale-up; 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 master cell bank (MCB); working cell bank (WCB) testing and characterization; cell cultures; seed trains; bioreactor operations; and metabolite analysis.

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. The position requires good documentation practices and routine reporting and communication of results, both internally as well as to clients.

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 cell line development and 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 cell line and upstream 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), cell culture optimization, culture scale up, clarification (filtration and centrifugation) techniques, 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 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 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), Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP)
• Identify, review and recommend continuous quality improvements
• Recommend, acquire and maintain equipment suitable for current industry standard cell line and upstream development work
• Keep current on industry best practices, standards, and technology pertaining to cell line and upstream 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 understanding of cell line development, molecular biology, and cell culture dynamics and growth
• 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
• Operational knowledge and hands-on experience with various cell line and upstream development instrumentation, e.g., Solentim VIPS, Cell Metric, Octet, CEDEX, BPFlex, Ambr250, incubators, and bioreactors
• Knowledge of aseptic techniques, scale-up strategies and equipment requirements
• Excellent technical problem solver, critical thinker
• Works well independently and in a team environment
• Excellent written and verbal communication skills
• 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 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 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 items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.