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.
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.
Internal Number: 1701105
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.