Key roles and responsibilities
This individual will be responsible for contributing to and realizing the long-term vision of Potency assays group and establishing assay strategies and the assessment and implementation of novel technologies. This individual will also be responsible for providing technical guidance to senior and junior scientists. Additional responsibilities include representation on program and cross-functional teams and support of regulatory submissions for clinical and marketing applications. The ideal candidate should be comfortable in working in a fast-paced, matrixed environment and have a proven track record of providing leadership in the development and implementation of potency assays that are compliant with USP/ICH requirements.
?Excellent understanding of MOA for therapeutic antibodies. Understanding of the regulatory requirements for the safety and efficacy testing of large molecule clinical drugs
?Extensive hands-on experience with the design, development, optimization and qualification of potency assays that reflect the MOA of antibody, ADC and other drug modalities for relative potency determination. Such assays include but are not limited to cytotoxicity assays, binding ELISAs, Octet, and reporter assay, etc.
?Experience in the use of live cell imaging systems and high-throughput liquid-handling systems is strongly desired
?Established external networks to stay current on industry best practices and emerging technologies in potency assay development.
?Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate complex data and the impact. Proven experience in supporting regulatory submissions such as INDs, BLAs, IMPDs, MAAs.
?Experience in leading and developing diverse, high-performing teams. Strong interpersonal skills and the ability to work in a multi-disciplinary team environment.
Education level + professional requirements
PhD or equivalent are preferred. MS or BS with considerable drug development experience will be considered.
Work experience (years / professional experience / industry experience / management experience)