Scientist II (Molecular and Cellular Biology; Upstream Processing

Position: Scientist II (Molecular and Cellular Biology; Upstream Processing)
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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  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
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