Principal Scientist (Biotherapeutic Bioanalysis) is a functional leader responsible for managing scientific and technical activities related to preclinical pharmacokinetics, nonclinical/clinical pharmacokinetic bioanalysis and immunogenicity assessments.
SPECIFIC DUTIES: • Responsible for the oversight of development of robust immunoassays for pharmacokinetic and immunogenicity assessments for the assigned discovery and development biotherapeutic programs. • Represent DMPK on cross-disciplinary discovery and development project teams for biologics and cellular therapies, formulating and executing project strategies in collaboration with functional teams. • Provide oversight of CROs for bioanalytical method development, validation and sample analysis for regulated toxicokinetic and clinical studies, and ensure compliance with applicable global standards • Write and critically review BA, Immunogenicity and PK/TK reports, and relevant sections of regulatory dossier in support of IND through NDA submissions. • Represent DMPK in interactions with internal and external stakeholders, as needed.
The position requires an individual with: • An advanced graduate degree in a relevant field (Ph.D., or equivalent) with deep expertise in immunoassay development • Expertise in flow cytometry and qPCR is a plus • Good awareness of regulatory and standard industrial practices in biotherapeutic bioanalysis • Broad understanding of the drug development process • Mentoring skills • Good communication and interpersonal skills to effectively represent function at internal working groups/project teams Domestic and international travel is mandatory as required.
About Celgene Corporation
Celgene CorporationDriven by PASSION FOR THE PATIENT.
-Preeminent Global Biopharmaceutical Company- ~8,000 Employees Worldwide- Operations in >60 countries and sales in >70 countries.
-Focused on Discovery, Development and Commercialization of Innovative Therapies for Unmet Medical Needs in Cancer and Immune-Inflammatory Diseases.
- 8 marketed products (hematology, oncology and immunology)- Focused on R&D; >30 Phase III programs underway and 300+ clinical trials
- Diverse technology platforms and commitment to sustaining innovation