Associate Director/Director, Commercial Supply Chain – Dynavax Technologies – Berkeley, CA, USA
The Associate Director/Director, Commercial Supply Chain will be responsible for overseeing the overall logistics activities and vendor management to support the process flow for the delivery of Commercial goods and services in a domestic and international environment, in a multiple temperature range distribution network.
• Develop and manage lot use strategies with Manufacturing, Regulatory and Quality; ensuring CMC changes are approved as needed to enable lot use.
• Proven ability to manage external manufacturing/supply organizations Participate in and lead supplier governance forums.
• Responsible for primary and secondary packaging & labeling activities; leading design and approval activities for generation and implementation of new and revised artwork/labels with Regulatory, Quality, and CMO sites.
• Support launch activities, initially for US launch followed by international launches.
• Develop tools for demand/supply analysis, production planning, volume & capacity studies, and participate in process improvement efforts and other risk mitigation and efficiency efforts.
• Manage/schedule drug substance (DS), drug product (DP), and finished goods (FG) production planning, rolling forecasts, and cold chain shipments worldwide in collaboration with Supply Chain Planner.
• Reduce supply chain risk related to single source suppliers and improve quality of incoming product through continuous supplier qualification process.
• Partner with Sr. Director, Supply Chain to develop and formally document supply strategy and processes.
• Establish, update and maintain policies and procedures required to maintain good manufacturing practices (GMP) compliance in the storage, distribution and returns of drug product.
• This position is the team expert in the importation and/or exportation of commercial related materials.
• Assure necessary documentation, permits and/or licenses, are obtained and maintained.
• Establish operational metrics to track, record and improve performance and develop a periodic report that succinctly outlines the supply chain status for management.
• Frequent coordination with a cross-functional team of professionals including Commercial Operations, Finance, Engineering, Manufacturing, Regulatory Affairs.Prepare documents as needed for FDA submissions including IND, NDA, BLA, and other regulatory authorities.
• Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and team-orientation.
• Other duties as assigned. Requirements Qualifications:
• The ideal candidate is well versed in capacity planning, S&OP, materials management and import/export, and must have a strong command of ERP and analytical tools.
• Must have enterprise resource planning (ERP) implementation experience.
• The associate director will have 8+ years GMP commercial biologics supply chain experience with 3+ years’ leadership experience in cold chain supply management. The director level incumbent will have 10+ years and at least 5 years leadership experience in cold chain supply management.
• Three plus years’ contract manufacturing operations (CMO), vendor management, as well as supplier relationship management (SRM) experience.
• Working knowledge of GMP and good distribution practices (GDP) with focus on commercial supply chain and manufacturing processes.
• Proven track record with establishing and maintaining strong internal and external partnerships.
• Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners.
• Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.
• Must have proven experience translating corporate objectives in overall planning, demand forecasting, and supply planning.
• Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
• Must be able to work in a fast-paced environment with minimal direction and have the ability to manage workload with changing priorities.
• A BA/BS degree in supply chain management or related discipline.
• Some travel required.
ADDITIONAL KNOWLEDGE AND SKILLS DESIRED, BUT NOT REQUIRED:
• Manufacturing and/or external manufacturing experience a plus
• Some supervisory experience, APICS certification, Lean Six Sigma training & project management skills are highly desirable.