This position is responsible for financial, analytical and budget support for the Sales and Marketing organization. Responsibilities include partnering with department and functional leaders within the organization in managing all financial deliverables including annual budgets, periodic forecasts, long-range plans, spending and supporting analytics including variance analysis.
This role may participate in contract negotiation/review/tracking/analysis, evaluation of accruals and other areas that may impact financial reporting. On an as needed basis, conduct financial modeling including scenario, valuation, cost, and sensitivity analysis.
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.
Responsible for a broad and critical set of duties spanning operational/logistical activities as well as creation and execution of Market Access marketing, strategies, and tactics. Function as a leader within the Commercial Operations team in coordinating plans of action and addressing issues within 3rd party vendors and across internal Dynavax teams such as sales and market access field teams, marketing, legal, market insights, and finance teams.
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.
The Accounting Manager will oversee the implementation and adherence to accounting policies and procedures and direct and coordinate the daily activities of the accounting staff to ensure timely and accurate record of the expenditures, assets, liabilities and equity transactions of the Company. This position is responsible for meeting deadlines and will direct a multitude of accounting activities including but not limited to monthly close process, reconciliations and year-end audit preparation.
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 part of the Help Desk Operations team to support documenting, troubleshooting, resolving, and prioritizing incoming help-desk requests; and will provide end users with technical support of company computers, applications, printers, telephones, and other related technologies. The incumbent in this position will be able to research and resolve difficult and complex problems in the group.
Help-Desk hours are Monday through Friday from 8:30 am to 5:30 pm. After-hours and weekend support are on a rotating shift within the team.
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.
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.
This QA position is a member of the Quality team and provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP), Pharmacovigilance Practices (GVP). In addition, support to the GLP and GMP areas will be provided as needed.
Areas of responsibility include:
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.