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The QA Specialist / Senior Specialist will be responsible for supporting all quality assurance activities related to development and commercial programs and products including, but not limited to, batch manufacturing and testing records, labelling, packaging and shipping records, QC test results, deviations, change requests SOP and batch record generation and revision, and the generation of documentation metrics.
The senior specialist may be part of a dynamic QA team responsible for CMO compliance and final product release.
Assist and coordinate the day-to-day administration of facility and corporate services under general supervision. Daily work encompasses a wide range of responsibilities including Reception, Shipping & Receiving, Administrative and Facilities.
Manages the design, maintenance and locking of clinical trial databases. Acts as the data management team lead on all clinical study data issues when activities are outsourced, between Dynavax and a contract research organization, or other vendors
Supports all clinical trial statistical programming activities, including writing and reviewing specifications, developing SAS programs to create CDISK-conforming data tabulations and analysis datasets and generate statistical outputs such as tables, listings and figures, reviewing and validating programmed datasets as well as statistical outputs produced in-house or by contract research organization (CRO) products, and coordinating the work of other statistical programmers.
This position may provide technical and project oversight of contract programmers.
Provide leadership and management oversight of clinical document control and clinical training, including managing the day-to-day operations of the clinical documentation archive, the team responsible for managing the TMF/eTMF , and maintenance and tracking of training records. Partner with Clinical Development, Quality Assurance, and Regulatory Affairs to enable the development and maintenance of Standard Operating Procedures (SOPs) and clinical records. Ensure Clinical Development is appropriately trained on SOPs. Implement process improvement initiatives such as e-sign, system improvements for eTMF to ensure continued adherence to regulatory requirements and inspection-readiness Develop and maintain Trial Master File SOPs.
This position is responsible for providing professional project management services to support key programs at Dynavax. The Associate Director, PM, will co-lead teams with the Project Team Leaders and will operationally manage R&D development plans for Clinical, Regulatory and for communications with significant independence.
Working with Project Leaders, this position will translate project strategies to project plans and manage project timelines, budgets and ensure adequate resources exist to achieve key milestones
The Revenue Manager has ownership of all aspects of revenue recognition and must understand, analyze, and communicate financial impacts throughout the organization. This role will routinely partner with others across multiple functions ensuring proper alignment with policies and controls for revenue recognition and reporting, in accordance with US GAAP.
This position is principally responsible, both individually as well as through external consultants, for the configuration, customization, security, support, integrity and management of Microsoft Dynamics AX in support of the finance function. As a strong business partner to the finance team, this position understands the business challenges and opportunities and works to lead the configuration and maintenance of value added solutions to meet the set business requirements and financial reporting needs. Additionally, this position is responsible for troubleshooting and problem resolution, management of system resources and performance, and support and maintenance of other finance system environments, as required.
Additionally, this position will collaborate with the various departments and IT to coordinate and manage the design, development, implementation and on-going support of other business applications including but not limited to defining system components, component interactions and interfaces, and the technologies and resources to be used with the business solutions.
The primary responsibilities of the position are to architect, design and implement IT Cloud Services, Disaster Recovery and Security Infrastructure Services. Additional responsibilities include but not limited to management of the IT Infrastructure and Security Operations, as well as ensure IT’s operational excellence in supporting current and future business requirements.
This position is responsible for the design, development, modification and evaluation of a technical infrastructure to expedite conduct and evaluation of clinical trials and basic research. Duties will include but not be limited to collaborating with project team to determine protocol design and develop statistical analysis plan; working with clinical data manager and clinical team to ensure quality data collection; interacting with statistical programmers to develop specification documents for creating CDISK-conforming analysis datasets and statistical outputs including summary tables, listings and figures; ensures appropriateness and accuracy of statistical outputs to support the development of clinical study reports, regulatory submissions, presentations and publications; and performing statistical analysis and research as necessary.
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.