We are seeking a Senior Scientist or Principal Scientist to join our Biotherapeutic team. This role focuses on in vitro characterization and pre-clinical drug development, contributing to the development of therapeutic antibodies. The ideal candidate will have a Ph.D. in a relevant scientific field with industry experience, with expertise in cell biology, immunology and molecular biology.
Key Responsibilities:
In Vitro Characterization:
- Design, develop, and optimize in vitro assays to assess the biological activity, potency, and mechanism of action of therapeutic molecules.
- Conduct immunological assays including binding affinity, epitope mapping, and functional tests (ADCC, CDC, neutralization, ADC) to evaluate candidate molecules.
Pre-Clinical Drug Development:
- Develop and support pre-clinical models, including in vivo studies, to drive IND-enabling experiments and regulatory submissions.
- Collaborate with cross-functional teams to assess pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of lead candidates.
- Partner with Contract Research Organizations and collaborators to oversee in vitro/in vivo testing and ensure comprehensive antibody characterization.
Cross-Functional Collaboration:
- Work closely with discovery and bioanalytical teams internally and externally to align on project timelines and objectives.
- Contribute to data analysis, interpretation, and communication in cross-functional meetings and external scientific forums.
- Support collaborations with external academic and industry partners for advanced therapeutic antibody research.
Documentation & Reporting:
- Prepare detailed technical reports, standard operating procedures (SOPs), and regulatory documentation to support IND submissions.
- Present scientific findings at internal and external meetings, as well as contribute to publications, patents, and federal grants.
Qualifications:
- Ph.D. or equivalent in cell biology, immunology, molecular biology, biochemistry, or a related discipline, with at least 2 years industrial experience in a related field.
Desired Skills:
- Strong background and broad knowledge of cell biology, immune oncology, and pharmacology.
- Proficiency in designing and execution on cellular biological, immunological and biochemical assays such as multi-color flow cytometry (FACS), ELISA, western blotting, IHC, ICC, and cell-based assays.
- Hands-on experience with primary cell culture (T cells/B cells), in vitro, in vivo, ex vivo models, and evaluating immune responses.
- Familiarity with pre-clinical development processes, including PK/PD studies and regulatory guidelines.
Eligibility Requirements:
- Must be legally authorized to work in the U.S.A.
Application Process:
Interested candidates are encouraged to submit their resumes with a cover letter to [email protected] , detailing their experience and passion for therapeutic antibody development.