This individual’s responsibilities will include, but are not limited to, execution of immune cell-based assays and various biochemical assays. These assays include primary immune cell bioactivity assays, cytokine / chemokine ELISAs, Taqman quantitative PCR, and flow cytometry, as well as (bio)analytical methods such as tissue processing / organic extraction and reverse phase HPLC. In addition, responsibilities will include test article preparation and sample management.
This position is responsible for providing confidential and high-level administrative support to the Vice President and General Counsel, Vice President Human Resources, as well as their respective direct reports. This position must exercise good judgment, initiative, and autonomy; handle special projects and coordinate activities between departments and outside parties; and contact internal and external personnel at all levels to gather information and accomplish objectives in a collaborative effort. Work is generally of a critical and/or confidential nature. This position must cooperatively and seamlessly work with other administrative support personnel and provide occasional back-up to the front desk.
This position will function as the QA-designated subject matter expert (SME) for development and commercial products. Perform and/or manage QA activities related to development and commercial product compliance and operations.
Duties will include: Assurance of development and commercial product quality, oversight of changes, exceptions, product disposition, audits/inspections, complaints and timely and meaningful resolution of potential Quality issues.
The QA specialist position is responsible for supporting activities related to Quality Systems including Document Control, Quality Records Management, Training, Supplier Management, Auditing, and Quality Event Management (Deviation, CAPA, Change). The position will support the implementation and maintenance of the electronic Quality Management System (eQMS), which will be used company-wide for document control, training, and management of Quality events such as deviations, complaints, and CAPAs.
We anticipate that an incumbent at the QA Associate will have less independence while the QA Senior Specialist will function more independently based on the experience.
As a member of the Analytical Development team, this role will support the early to late stage drug development programs at Dynavax including oligonucleotides, peptides, and proteins. The successful candidate may develop, transfer, and qualify analytical methods for drug substance and drug product release, stability and characterization.
This position will support early- to late-stage development focused on formulation and compatibility studies.
As a member of the Analytical Technologies team, this role provides technical leadership and managerial guidance to analytical staff for the development of analytical methods for testing and characterization of oligonucleotides, peptides and proteins used in cancer immunotherapy and vaccine products. The role will support analytical development activities for DVAX drug candidates from early drug development programs to commercial products. The successful candidate will monitor industry practices and regulatory standards and implement state of the art method development and validation approaches.
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.
This position provides confidential and high-level administrative support to the Vice President of Global Technical Operations and his direct reports. The ideal incumbent will exercise good judgment, initiative, and autonomy in supporting the management team in Global Technical Operations. Other duties will include special projects and coordination of activities between Technical Operations and other departments, as well as external parties. Initiate contacts with internal and external personnel at all levels to gather information to prepare for meetings and/or accomplish objectives in a collaborative effort.
The work is generally of a critical and/or confidential nature. This position must cooperatively and seamlessly work with other administrative personnel and provide occasional back-up to the front desk.