SUMMARY/JOB PURPOSE:
As a member of the Biotherapeutics group, the incumbent will play a key role in supporting the group’s discovery and preclinical development efforts by possessing skills and experience in recombinant antibody and bispecific antibody production and purification/characterization. The incumbent will be responsible for delivering high performing and high-quality mammalian cell lines that enable early-phase biologics manufacturing for further development as potential therapeutic candidates or as ADCs. The ideal candidate will design and test vector constructs, engineer host cells, conduct transfection, selection and clone generation campaign in CHO cells, and apply a deep theoretical understanding of recombinant protein expression to guide the improvement of titer in stable cell lines.
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 is also an important part of this role.
- Perform therapeutic CHO cell line development processes including transfection, single cell cloning, imaging analysis to document monoclonality, clone screening and progression, characterization, and cell banking and stability assessment of cell banks using state-of-the-art equipment
- Drive innovation through the development of improved expression vectors and genetic components, host cell line engineering and/or cell line development process optimization
- Identify emerging practices for biologics therapeutic cell line development and manufacturing to shape scientific strategies and continued innovation
- 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/EXPERIENCE/KNOWLEDGE & SKILLS:
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.
- 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.
