Additional Information
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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
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