1）Create, define, and lead an attribute sciences team within the analytical development group to meet the expanding needs of Frontier pipeline in the field of large molecule and peptide drugs.
2）Lead the overall scientific, technical and operational efforts within Analytical group in regards to physicochemical characterizations and analytical methods.
3）Establish procedures and protocols that would enable a deeper understanding of the impact of molecular attribute on product safety and efficacy to justify and establish the control strategy.
4）Deliver timely data and process knowledge needed to meet Frontier project milestones and associated regulatory requirements. This includes the design of protocols, execution, reporting and approval of characterization and qualification reports that support development activities.
5）Build the scientific knowledge, capabilities, and strategies in molecular characterization that enable fast to clinic/fast to market product development and commercialization. Maintain current awareness in areas of expertise.
6）Evaluate existing analytical method packages for accuracy and compliance with current ICH/FDA guidances.
7）Maintain a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs. Budget and track external expenses for CMO/CRO bio-analytical activities.
8）Participate in CMO/CRO selection, management and auditing as needed. Interact effectively and transparently with functional leads within group, and with other Frontier stakeholders (Quality, Toxicology/DMPK, Clinical , Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Business Development, etc.).
9）Establish internal capabilities and tools for rapid characterization of product quality to enable upstream, downstream, and formulation development and optimization.
10）Identify and establish partnerships with external vendors to leverage capabilities not available in-house.
11）Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support discovery and product development.
12）Maintain currency with applicable global regulations and industry standards for analytical testing and characterization of large molecule products.
13）Define science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
14）Participate effectively in internal development programs and in external collaborations by representing the analytical development organization as needed.
15）Develop the bio-analytical staff to function effectively in cross-functional teams and collaborations.