Senior Scientist II - Cell Line Development

MacroGenics, Inc.•Rockville, MD

About The Position

The Senior Scientist II is a key member of the Cell Culture Sciences team in the BioPharmaceutical Development (BPD) department. Reporting to the director of Cell Culture Sciences, this individual is responsible for Cell Line Development (CLD) functions, including generation of cell lines that produce recombinant protein molecules in mammalian cells using various vector systems and selection methods. In addition, this individual will be the key contributor to Master Cell Bank and Working Cell Bank production and testing, and will support mammalian cell culture process development activities.

Requirements

Bachelor’s degree in Cell Biology, Biology, Biochemistry, or relevant life science field, and a minimum of 11 years of experience in biopharm industry, working on mammalian cell culture and/or cell line development,
Master’s degree in the relevant fields with a minimum of 9 years of experience in biopharm industry,
PhD in the relevant fields with a minimum of 3 years of experience in biopharm industry.
In-depth knowledge in cell expression systems for mammalian cell culture.
Hands-on experience in Cell Line Development activities, including transient transfection, building stable pools, and clonal cell line selection.
Experience in supporting production of MCBs and WCBs. Strong knowledge of testing, characterization and qualification of MCBs and WCBs and relevant regulatory guidelines.
Ability to set-up, maintain, and troubleshoot equipment and drive implementation of new technologies for Cell Line Development.
Ability to independently author technical documents including protocols and reports.
Strong verbal presentation and writing skills to communicate effectively.
Demonstrated capability of collaborating with other functional areas and representing the Cell Line Development function on cross-functional project teams.
Strong organizational skills and ability to prioritize multiple projects to completion.
Willingness to work on weekends as needed.

Nice To Haves

Experience in authoring and reviewing Cell Line Development and Cell Banking sections in regulatory dossiers.
Hands-on experience of mammalian cell culture with small-scale or bench-scale bioreactors.
Experience in automated liquid handling systems or workflow.

Responsibilities

Develop and characterize cell lines that express desired molecules. This includes generating stable pools, selecting clonal cell lines suitable for GMP production, and generating early material to support process development.
Collect and analyze data, and summarize experiments for data organization and presentations. Present data at internal and external meetings, and at scientific meetings.
Be the key contributor to production of Master Cell Banks (MCBs) and Working Cell Banks (WCBs). Be the subject matter expert on the requirements for MCB and WCB testing.
Develop and evaluate Cell Line Development strategy and workflow to improve efficiency and overall results, such as evaluating new equipment, technologies, or materials.
Author technical reports, and relevant sections in regulatory dossiers.
Maintain accurate and timely records of all experiments and data in notebooks and in digital format.
Maintain the laboratory equipment including automated bioreactor systems and ensure a safe working environment.
Maintain awareness of current scientific trends and technical aspects from conferences, local meetings, and the literature.
Collaborate closely with process development and research teams to support their work and to maintain or improve speed to clinical production.
May supervise one scientist or associate.