Associate Director, Analytical Technologies
Global Technical Operations
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
As a member of the Analytical Technologies team, this role provides technical leadership and managerial guidance for development of analytical methods for testing and characterization of DVAX vaccine drug development candidates. The position will also oversee external quality control activities such as release and stability testing. This position will work with cross-functional teams to define project needs, deliverables and milestones to meet regulatory requirements, and assure business goals are met.
- Oversee external QC release and stability testing of vaccine candidates
- Direct development, optimization, and validation of test methods for assigned projects.
- Manage the activities of external research laboratories that have been contracted to conduct assay development and/or sample testing.
- Author, review and approve technical documents including analytical method development reports, method validation protocols and reports, standard operating procedures in compliance with regulatory requirements.
- Interact internally and externally with management personnel to influence and/or negotiate technical decision-making.
- As analytical subject matter expert, author, and review regulatory documents including submission and responses to agency requests
- Other duties as assigned.
- PhD/Master’s degree in relevant scientific field with a minimum of 8+ years/ 12 + of industry experience in analytical development/quality control of biologics and 3 plus years’ management and leadership experience. Experience in vaccine development is a plus.
- Proven ability to translate business objectives into effective technical and operational plans and successful implementation of such plans.
- Drug development experience from IND enabling stage to product commercialization is preferred.
- In depth knowledge of cGMPs and other regulatory requirements pertaining to biotechnology and pharmaceutical industries is required.
- Must have expert knowledge of product characterization techniques for oligonucleotide, peptides and/or proteins and in depth experience with a wide range of analytical techniques including Potency assays, HPLC, HPLC-MS, spectrophotometric assays, SDS-PAGE, and
- Must have strong understanding of statistical data analysis.
- Excellent analytical, technical writing, communication and data management skills are required.
- Proven leadership ability and problem-solving skills are a must.
- Personal attributes required include:
- Flexibility and integrity,
- Goal oriented and self-starter,
- Practical approach to problem solving,
- Demonstrated good judgment and decision-making experience,
- Collaborative and team oriented.