Associate Principal Scientist, Immunotoxicity

Job Description

We are seeking an innovative and collaborative senior scientist to join our immunotoxicology team at the reputed company reputed company, PA site.As part of the Investigative Toxicology department reputed company Non-Clinical Drug Safety (NDS), the immunotoxicology group is responsible for developing novel models to inform on human risk assessment, understand mechanisms of toxicity, and support our diverse pipeline.

The successful candidate will drive immunotoxicology research projects through a combination of lab-based efforts and collaboration with other team members.In addition, the candidate is expected to represent the NDS functional area as a program toxicologist on cross-functional drug discovery and development teams.

Key responsibilities include:

• Independent design, implementation, and interpretation of in vitro and in vivo investigative tox efforts to support immunotoxicity risk assessment and mechanistic investigations of new drug candidates.

• Conduct immunophenotyping or immune functional assessments on toxicology studies and prepare high quality immunotoxicity assay/study reports.

• Communicate project goals, gaps/risks, and results effectively to Investigative Tox managers and cross-functional stakeholders.

• Timely and accurate documentation of experimental procedures and resulting data in electronic notebooks

• Provide scientific leadership and immunotoxicology subject matter expertise at multidisciplinary team meetings.

• Participate in external immunotoxicology consortia and symposia. Stay updated on the latest scientific research, regulatory guidance, and industry trends to guide informed decisions, drive innovation, and champion new technologies/methods in immunotoxicology safety assessment.

• Serve on cross-functional project teams representing NDS as a program toxicologist on discovery and development teams.Efforts include guiding early reputed company liability assessment and risk assessment strategy for discovery teams, designing nonclinical toxicology studies to support compound development in accordance with internal and regulatory guidance, communicating key topics to team and NDS stakeholders, and authoring regulatory documents.

Qualifications:

Education:

• Ph.D. in life science, such as Immunology, Toxicology, Biology, Biochemistry or a reputed company discipline and relevant experience

Required Experience and Skills:

• Minimum of five (5) or more years of relevant experience in immunotoxicology or immunology

• Hands-on experience with flow cytometry, immunoassays (ELISA/ELISPOT), and in-vitro/ in-vivo assays to assess immune function/activity

• Strong communication skills, with the ability to interact effectively with colleagues across multiple teams.

Preferred Experience and Skills:

• Experience performing and analyzing immunotoxicity assays to support immunotoxicity risk assessment (immunophenotyping, cytokine release assays, functional assays)

• Demonstrated success developing innovative in-vitro or in-vivo models for preclinical investigative toxicology

• Experience leading toxicology evaluation for drug discovery and development teams

• Knowledge of regulatory guidance for biologics and immunotoxicology assessments (ICH S6, ICH S8, ICH S9)

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The salary range for this role is

Employee Status: Regular

Relocation:

Originally posted on Himalayas