Principal Scientist (Cell Line Development)

SUMMARY/JOB PURPOSE

The incumbent will play a key role in supporting the Biotherapeutics group's discovery and preclinical development efforts by possessing skills and experience in recombinant antibody and bispecific antibody production and purification/characterization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Design and execute experiments to develop CHO-based cell lines for biologic therapeutics moving into clinical development.
• Significant effort designing complex experimental approaches to improve expression systems and workflows through innovation and implementation of new technology.
• Drive innovation through the development of improved expression vectors and genetic components, host cell line engineering and/or cell line development process optimization.
• Represent the cell line development team on cross-functional projects, making decisions for cell line activities and effectively communicating results, progress and plans.
• Comply with company health and safety policies and general laboratory practices.

SUPERVISORY RESPONSIBILITIES

No supervisory responsibilities. Individual contributor role.

Education

• Bachelor’s degree in related scientific discipline such as molecular biology, biochemistry, biology or microbiology and a minimum of eleven (11) years of experience in the biotechnology/pharmaceutical industry;
• or, Master’s degree in related scientific discipline such as molecular biology, biochemistry, biology or microbiology and a minimum of nine (9) years of experience in the biotechnology/pharmaceutical industry.
• PhD degree in related scientific discipline such as molecular biology, biochemistry, biology or microbiology and a minimum of five (5) years of experience in the biotechnology/pharmaceutical industry.
• Equivalent combination of education and experience

Experience

• The role is for an experienced incumbent who is eager, hands-on, detail-oriented, driven, self-motivated and experienced to contribute with minimal onboarding or training.
• The candidate must have demonstrated proficiency in molecular biology, vector construction and genetic elements that impact recombinant antibody/bispecific expression.
• The candidate must have experience with various stable CHO expression platforms to articulate pros and cons and recommend one suitable for developing manufacturing cell lines.
• The candidate must be well versed in transfection methodologies as well as screening and selection workflows.
• The candidate must have a deep understanding about regulatory requirements with respect to demonstrating monoclonality.
• Must have experience in culturing CHO cells in different formats such as shake flasks, spin tubes, and deep-well plate fed-batch processes.
• Experience in Ambr fed-batch processes is a plus.
• The candidate must have experience in single cell cloning and imaging technologies to prove monoclonality.
• Experience in running titer determination and standard downstream product quality assessments.
• Author and review cell line development reports, summaries and presentations.
• Experience in analytical techniques such as HPLC, LC/MS, and/or CE is a plus.
• Familiarity with automation platforms and data analysis tools is a plus.

Knowledge/Skills

• Solid understanding of mammalian protein/antibody expression, structure, and activity.
• Ability to set goals with an understanding of priorities and impact to program, the department and the organization.
• Ability to thrive in a high-expectation, fast-moving environment.
• Strong communication, organization, and documentation skills.
• Ability to design and execute activities/studies aimed at producing and characterizing recombinant antibodies and bispecifics, to interpret experimental results, and to formulate conclusions and next-steps based on the data generated.
• Prior experience with electronic laboratory notebook documentation and workflow management is a plus.

WORKING CONDITIONS

• Environment: primarily working in laboratories or in office
• Exposures encountered: Potential exposure to hazardous chemicals/materials.