Manager/Director of Materials Management
Location: Bristol, PA
The Manager/Director of Materials Management will lead those functions with primary responsibility for ensuring robust development and reliable GMP supply of raw materials for the manufacture of client products. This will include coordinating with internal groups, such as Purchasing, Manufacturing, and Quality Control as well as external suppliers and, contract test labs (CTLs). This individual will be responsible for supply chain planning (demand planning, supply planning and materials planning), development and oversight of logistics and distribution providers.
This leadership role will report to the site head and will hire and develop an appropriate CMC team to ensure that Abzena’s operational and long-term objectives are met. The Head will work closely with key stakeholders including to define and build the capabilities required to effectively manage Abzena (PA)’s materials planning, inventory control, logistics and shipping and receiving.
Responsibilities to include:
- Oversees materials management staff responsible for shipping, receiving and inventory control.
- Responsible for materials planning, purchasing, inventory control and timely release to ensure that sufficient supplies are available for product manufacturing.
- Develops and maintains compliant GMP materials storage facilities.
- Ensures that an uninterrupted supply of materials is available to ensure no delays to production and process development schedules.
- Directs communications with internal customers (QC, Manufacturing, Project Management) and external suppliers regarding supply, demand and scheduling issues.
- Develops procedures and systems to ensure proper control of GMP materials.
- Work closely with other functions to drive overall supply chain efficiency and product delivery in a timely, cost-efficient manner.
- Drives development of relevant metrics, data collection and reporting.
- Collaborates with peers at other sites to ensure that processes are consistent, reliable and efficient and that cross-site transfers can be executed seamlessly.
- Works with the partner organizations and internal QA as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any deviations, investigations, CAPAs… are initiated, addressed and closed within target timeframes.
- Participates in internal, partner and regulatory audits.
- Provides materials management support for capital projects, technology transfers and continuous improvement efforts.
- Builds and nurtures employee engagement by creating environment within which individuals and teams can grow and excel. Serve as coach/mentor as well as a key team player
- Prepares annual and multi-year financial budgets and forecasts. Manage headcount and expenses to meet approved spending plans while delivering on commitments.
- Stays current with current industry standards, new trends and all applicable regulations.
- Develops and maintains external relationships with subcontractors, and service providers.
- A minimum of 15 years in biopharmaceutical GMP supply chain management with a minimum of 10 years in leadership roles. Experience with pharmaceutical manufacturing a plus.
- Deep knowledge of raw materials, pharmaceutical production processes, quality control, and material costs.
- Degree in operations management or similar related field required.
- APICS certification preferred.
- IATA certified for shipping of dangerous goods.
- Proven experience in building materials management departments, processes and systems to support biopharmaceutical development.
- Working knowledge of the biopharmaceutical lifecycle from early clinical through commercialization preferred.
- Some travel may be required.