Principal Research Investigator, Cell Line Development
Position Summary
Lead the cell line development function within Technical Development and Transfer (TDT) to build a cell line development platform and deliver highly productive cell lines to support Amicus Therapeutics pipeline.
Roles and Responsibilities
– Responsible for generating high producing cell lines with focus on the development of mammalian cell lines in the production of recombinant proteins for clinical and commercial manufacturing.
– Responsible for production cell line development activities (internally or oversee CRO) including transfection, selection, single cell cloning, high throughput screening, characterization of clonal cell lines using scale-down models, cell banking, and cell line stability studies.
– Developing and optimizing new protein expression platform including designing, constructing, and evaluating novel expression constructs and expression system.
– Clone screening and selection of top clone to develop a research cell bank (RCB)
– Oversee manufacturing of MCB/ WCB
Requirements:
Requirements
– Ph.D. in molecular biology or related field with 8 – 10 years of relevant cell line development experience or MS in molecular biology or related field with 15 years' experience
– Demonstrated experience to analyze and summarize cell line development data to support final clone selection
– Experience in cell culture, cell transfection, selection, single cell cloning, high throughput screening, characterization of clonal cell lines, stable cell line generation, cell line qualification, etc.
– Demonstrated experience in cell banking for both development and for creation of GMP cell banks
– Partner with QA and Regulatory for release, regulatory submissions
– Excellent problem solving skills
– Experience and strong knowledge with cGMP/GMP, ICH guidelines and regulatory requirements for cell lines
– Experience in cell or gene therapy is a plus
Experience and Skills
– Experience building teams, mentoring and training junior staff
– Understand, interpret, and develop strategies to address regulatory requirements
– Demonstrated ability to build high performing teams with strong scientific and technical acumen
– Detail-oriented with excellent verbal and written communication and negotiation skills
– Participate in business team meetings and work with other functional managers
Travel
• 10 – 15%
