Description

Quintara Discovery (QDI) is a dynamic and growing biopharma CRO in the San Francisco Bay Area, with a proven track record of working with leading biopharmaceutical companies, emerging start-up companies, universities, and leading research institutes. We are looking for a highly motivated scientific leader in managing our bioanalysis group under Good Laboratory Practice (GLP) to develop and conduct validated bioanalytical assays in supporting the evaluation of potential therapeutics for our clients.

Location:

Hayward, CA

Position Summary:
Director of GLP Bioanalysis

Key responsibilities:

• Responsible for timely delivery of bioanalytical results and reports, and regulatory requirements for assay development, validation and study sample analysis, conducted in compliance with GLP regulations and in line with global regulatory guidelines
• Responsible for the timely review, interpretation and presentation of bioanalytical study data to the Sponsor.
• Leadership/oversight of troubleshooting and issue resolution efforts
• Interact effectively and build strong collegial working relationships with the Discovery BA, Quality Assurance and the Sponsor
• Provides guidance on the design, execution and interpretation of bioanalytical assays as well as bioanalytical strategies for the organization. Scientific expert who contributes to responses to questions from regulatory agencies on bioassays. This may be achieved as an individual contributor or by collaborating with different disciplines and across cross functional teams
• Responsibility for the organization and functioning of the laboratory according to the principles of GLP

Requirements

Minimum Qualifications:

• Ph.D. in Bioanalytical Chemistry, Biochemistry, or a relevant discipline
• A strong background in the principles of regulated bioanalysis including extensive knowledge and understanding of GLP regulations, ICH Guidelines, experience of interacting with Regulatory Authorities, and authorship of Regulatory Correspondences and Dossiers is required
• A minimum of 10 years of experience in the pharmaceutical industry with a proven track record of bioanalytical method development and validation. Ability to assist with bioanalytical method troubleshooting across a variety of platforms. Domain expert in analytical platforms such as LC-MS/MS.
• Knowledge and/or experience in large molecule assay development and validation, such as ELISA and MSD, is highly desirable 
• Demonstrated ability to make sound scientific interpretations and resolve issues as they arise
• Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities and very aggressive timelines
• Excellent written and verbal communication and presentation skills. Experience in writing technical reports and scientific manuscripts.
• Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting
• Organized, self-motivated, and proactive