455 Mission Bay Boulevard South San Francisco, CA 94158 US
Pay Rate Range: $100-116
Reason: Vacant Position
Department: Research Operations
Job Category: Research & Development
Job Title: Director, Bioanalytical
Duties: Directs bioanalytical activities in the research and/or development of an organization's products, projects and programs. Conducts and collaborates with others on bioanalytical issues relevant to long-term objectives and concerns. Develops and directs state of the art bioanalytical technologies such as, ligand binding assays, bioanalytical and immunogenicity methods, metabolite identification for analysis of large molecules in biological fluids and tissues to support drug discovery, preclinical and clinical development. Develops strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects. Makes recommendations for final decision on administrative or operational matters. Supports management of external contract laboratories when needed to provide non-GLP and GLP bioanalytical data. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Oversees bioanalytical method development and validation for PK and ADA samples in clinical development.
Oversees PK, biomarkers and immunogenicity sample testing Designs and executes bioanalytical studies that follow internal SOPs and GLP guidelines Authors and reviews bioanalytical reports to support CSRs and BLA submissions Manages and collaborates with vendors to ensure high quality and timely support to the programs Remains current with the bioanalytical field in drug development (especially biologics), both in development of new analytical techniques, and in following regulatory guidance Communicates cross-functionally with groups such as clinical pharmacology, DMPK, biomarker and clinical development/operation groups to ensure appropriate project support.
Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
Establishes goals, structures experiments, analyzes and reduces data, recommends and plans actions to achieve project objectives.
Provides scientific/technical guidance, leadership and decision-making as appropriate.
Skills: Experience in bioanalytical assay development, validation, sample analysis and report writing is required. Knowledge of large molecule drug development, and bioanalytical regulatory guidance, is highly desirable. Strong verbal and written communication skills are required. Project management skills are required. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Must have a demonstrated ability to work with senior management. Must be goal-oriented, quality-conscientious, and customer-focused. Good laboratory compliance and safety practices are a must. Demonstrated ability to develop successful relationships with and influence customers, both internal and external. Understands how to set expectations and negotiate proper milestones to track progress. Must have strong negotiation and influencing skills.
Education: A minimum of a Bachelors degree in a scientific or engineering discipline is required. An advanced degree is highly desired. Equivalent experience may be accepted. A minimum of 13 years experience in the pharmaceutical or other technology based product research and development industry is required. A minimum of 10 years previous management experience is required. Expertise in pharmaceutical research /development and GLP requirements is required.