Scientist, Antibody Process Development

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Are you seeking to use your passion, vision and creativity to make a difference in people's lives? Do you view an innovation-driven opportunity as an investment in your future? Bring your talent to our Bio-Techne antibody team and join us in creating innovative products for research, diagnostics and therapeutics.

Bio-Techne is an industry leader in antibody discovery and development dedicated towards a broad range of applications including therapeutics. We leverage our technological capabilities to enable the world's leading pharmaceutical companies in furthering their clinical development in areas such as immunotherapy.

Position Summary:

Scientist, Antibody Process Development, Cell & Molecular Biology Focus. We are seeking a highly motivated and creative Scientist to join our antibody process development team. This position is primarily responsible for a broad range of development activities that will support the release of new GMP and RUO antibody products. As part of our dynamic and collaborative team, you will leverage your skillset in a bench-focused position. In this role, you will generate stable expression hosts (CHO, HEK, E. coli) that will enable scalable, commercial-scale production of recombinant antibodies and antibody variants. You will employ molecular biology techniques to generate expression constructs for both stable cell line generation and transient production of recombinant antibodies. In some instances, bioinformatics and data mining approaches will be employed to guide antibody engineering projects. As a Scientist in this role you will also contribute to the development of early-stage cell culture processes to optimize antibody production and quality. Importantly, you will also lead projects to characterize GMP/RUO candidate antibodies, including assessment of antibody binding specificity, purity, and the development of bioassays to the measure the function of antibodies. In addition, you may contribute to the development of new antibody conjugation workflows and processes. Overall, this role is expected to develop and implement innovative technologies to streamline process development and support downstream manufacturing of antibodies. You will collaborate with various groups within the antibody business unit as well as Operations, QC, and QA/RA groups to ensure timely release of antibody products.

Key Responsibilities:

• Generate stable expression hosts (CHO, HEK, E. coli) for the scalable production of recombinant antibodies and antibody variants (ScFv, bispecific, ScFab).

• Perform characterization of stable cell lines, including determination of long-term expression stability, and measurement of transgene copy number using state-of-the-art molecular biology methodologies.

• Conceive, design and construct expression plasmids for both stable and transient production of recombinant antibodies across different expression hosts.

• Construct master cell banks and working cell banks for stable cell lines.

• Lead projects to characterize recombinant antibodies produced by various expression hosts using multiple techniques, including immunoassays, flow cytometry, and SDS-PAGE. Develop bioassays/cell-based assays to assess antibody function for QC release purposes.

• Work with downstream teams to develop news for conjugation of recombinant antibodies to fluorescent dyes.

• Provide though leadership in the antibody development space, stay informed about emerging trends, technologies, and breakthroughs in antibody research and therapeutic development.

• Create and manage cGMP compliance documents including batch records, SOPs, risk assessments, and other documentation.

• Work closely with the Custom Development, Quality Assurance, Applications teams, and CDMOs to identify and understand customer needs.

• Support operations and manufacturing QC for commercial product testing, release and troubleshooting when needed.

• Responsible for experimental design, data collection and interpretation.

• Play a lead role in the establishment of new lab spaces for cell line development, take the lead on identifying, ordering, and qualifying new equipment.

• Strong presentation and analytical skills are a necessary part of this high visibility role.

• Lead small teams of research to achieve project goals when necessary.

Qualifications

JOB QUALIFICATIONS

Education and Experience:

• Ph.D. or M.S. or equivalent with experience in molecular biology, biochemistry, cell biology or a related field. Ph.D and up to 5 years of experience OR Masters with 8-10 years of experience.

• Experience with mammalian cell culture (adherent and suspension lines). Experience with transferring cell culture processes across scales/platforms would be a strength. Familiarity with microbial expression systems (E. coli) would be a plus.

• Experience with molecular biology/cloning techniques, hands-on experience in the design and construction of expression vectors (restriction cloning, Gibson assembly, golden gate).

• Experience with multiple assays to characterize antibodies, including immunoassays, SDS-PAGE, bioassays, cell-based assays.

Knowledge, Skills and Abilities:

• Knowledge/experience with immunology would be a plus in this role.

• Proven skills in experimental design and data analysis as well as critical review of primary literature.

• Ability to document work and write SOPs in a manner consistent with downstream cGMP manufacturing is critical.

• Demonstrated ability to manage complex projects to completion, working across multiple teams and partners to ensure success.

• Strong collaborator and self-starter as well as ability to work independently.

• Strong organization skills and attention to details.

• Personable, friendly, and demonstrates empathy towards others.

• Ability to function well in a dynamic environment where projects and business needs may require changes in project focus.

• Good verbal and written communication skills.

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!

• We invest in our employees' financial futures through 401k matching and an employee stock purchase plan.

• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.

• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Bio-Techne is an E-Verify Employer in the United States.