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Associate Director/Director, Supply Chain

Supply Chain

US-Emeryville, CA OR Remote

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.

Supply Chain Associate Director/Director will lead multiple projects to build out the commercial supply chain infrastructure and operations to support US market and global expansion. Ideal candidate will be experienced in pharmaceutical artwork and serialization requirements and processes. With multiple projects on the horizon supporting product and geographic expansion, Dynavax is looking for an experienced professional who can lead multiple initiatives in coordination with other internal functions and external partners.

Responsibilities

·        Oversee development of product labeling in support of international expansion, and implement improvements to US labeling:

o  Work with Commercial and distribution partners to define labeling requirements.

o  Work with Regulatory Affairs to ensure labeling meets country-specific requirements.

o  Work with CMO to develop and implement new packaging artwork.

·        Lead Serialization program:

o  Process Owner of Dynavax’s TraceLink serialization program and system (TraceLink).

o  Lead required changes to support DSCSA 2023 requirements.

o  Coordinate EU serialization program in support of Dynavax GmbH.

o  Implement serialization requirements in support of new country expansion.

o  Support TraceLink system administration (quarterly audit trail reviews, TraceLink release upgrades) in conjunction with System Owner.

· Lead improvement projects with internal and external partners. Range of projects could include:

o  Set-up operations of new European 3PL and integrate with internal processes.

o  Support supply chain planning and launch of new commercial products, ensuring compliance with artwork and serialization requirements.

o  Implement inventory management program to better control company risk, including establishment of secondary supply depot.

o  Work with CMOs to improve operations and intercompany coordination.

o  Support shipping validation and logistics/cold chain management initiatives.

o  Identify and drive initiatives to improve efficiency and reduce cost.

· Ensure Dynavax and partner SOPs are thorough, up-to-date and ensure successful operations.

o  Implement improvements stemming from new regulatory requirements or corrective actions.

· Collect, evaluate and analyze data to inform decisions and/or action plans that support program / process improvement.

o Prepare supply chain project status reports (KPI dashboard) and summaries for Dynavax and partners.

· Support the organization in maintaining a work environment focused on quality, collaboration and teamwork.

· Other duties as assigned.

Qualifications

· A Bachelor’s degree in Supply Chain Management or related discipline.

· 5+ years of supply chain experience in commercial supply chains in biotech/pharmaceutical industry. 

· Experience with pharmaceutical artwork requirements and development process.

· Familiarity with TraceLink Serialization system, or ability to master new software.

· Experience managing operations with external suppliers (CMO, 3PL)

· Working knowledge of cGMPs/cGDPs and pharma industry procedures and regulations.

· Strong project management experience defining objectives, scope and coordinating cross functional teams through project execution.

· Ability to anticipate/define problems, collect and analyze data, draw valid conclusions and execute corrective actions and preventative measures.

· Strong interpersonal skills and the ability to work independently, as well as a member of a team.

· Must have strong verbal, written, presentation, communication and negotiation skills.

· Organizational, time management, and project management skills are required.

· Proficiency with: Microsoft Word/Excel/PowerPoint/Project and ERP software.

· Available for off-hours questions and calls with international sites. 

· Must have the proven ability to make well thought out decisions under stressful and conflicting situations.

· Ability to stand or sit for prolonged periods.

· Must be able to perform repeating motions that may include the wrists, hands and/or fingers.

· Occasional travel required, as needed.

· Full COVID-19 vaccination is required for this position.

Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.