工作职责：Role: Provide Biologics Development leadership and strategic direction on design, project plans and execution for the company’s process development, formulation, analytical development and IND-enabling activities in compliance with regulatory standards. This position partners with functional heads of discovery and carry out responsibilities via both in-house effort and outsourcing. Support CMC portions of regulatory filings, and achieve all corporate and program goals. Essential Functions: • Develop product and related technology roadmap to support the Company’s business objectives. • Build, mentor and assure appropriate management development for key personnel. • Direct the design and development of new products, including drug substance and drug product manufacturing processes. • Provide strategic vision and direction to pharmaceutical development through process science, analytical method development, pre-formulation, formulation, product development and characterization programs. • Conduct due diligence of partner selection for manufacturing, based on knowledge of pharmaceutical facility design, commissioning, validation and operation. • Provide guidance for non-clinical formulation work, toxicology and clinical feedback into robust dosage forms and processes for IND-related regulatory submissions. • Prepare and present reports outlining the outcome of technical projects and make recommendations for actions and budget necessary to achieve desired results. • Participate in meetings with holding company, collaborators, and investors and ensures information communicated is accurate and up to date regarding industry trends and standards. • Ensure adherence to SOPs, GXPs and worldwide health authority regulations as appropriate, both internally and externally. • Oversee and manage development budget and headcount.
任职资格：Preferred Experience and Skills: • Minimum of 15 years of experience in biotechnology drug development. • Results-oriented, self-motivated individual with proven leadership and interpersonal skills. • Demonstrated success in technical proficiency, scientific creativity, team building, external collaboration, and product delivery. • Experience in intellectual property and patent prosecution. • In-depth expertise with biologic production processes including developability, cell culture/fermentation, purification, formulation, and lyophilization. • In-depth expertise in analytical methodology for proteins. • In-depth expertise in nonclinical development requirements including toxicology and preclinical pharmacology. • Established reputation in the scientific community as a thought leader with a robust record of publications. • Ability to meet development goals on aggressive timeliness while having a record of effective collaboration with cross-functional teams. • Knowledge and experience with FDA and other regulatory bodies and guidelines. • Excellent teamwork and communication skills. • Ability to motivate and influence teams to accomplish goals in a dynamic changing organization. • Expert knowledge of immunology, oncology, analytical biochemistry, or related disciplines.
