Scientist II,Cell Line Development Job Mississauga area,Ontario Canada,Science

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.

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…

Scientist II, Cell Line Development