Associate Director, Supply Chain Management Lead

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

The Associate Director, Supply Chain Management Lead will oversee the warehouse team and will be a member of the NGB Operations Leadership team, reporting to the Head of Operations. They will be responsible for managing and coordinating the warehouse and facility supplies in alignment with the Process operations teams needs and ongoing GMP facility activities. Beyond warehouse workflows, this individual will be a key leader in the pilot plant supply chain network and integrated into the Rahway site warehousing operations.

Job Responsibilities:

• Oversee all NGB warehouse operations, ensuring compliance with GMP storage requirements and handling considerations.

• Manage the logistics team responsible for material movement, inventory control, outbound logistics,  local cell banks and ensure compliance with EHS and quality standards.

• Interact with various on-site and off-site centralized warehouse partners to ensure shipping and reciept of NGB materials is scheduled and delivered.

• Integrated into the Process Operations leadership team in order to better understand clinical campaign needs and voice of the customer.

• Oversee warehouse operations including storage and handling of cryogenic, frozen, and ambient materials, and includes all SAP/COMET system transactions.

• Working as a lead for the materials planning and management function to build ERP (i.e., SAP) for the new facility.

• Drive continuous improvement in warehouse processes and collaborate with operations, engineering, safety, and quality teams.

• Deliver on quality adherence and performance metrics.

• Conduct audits and inspections, approve SOPs, and monitor adherence to GMP standards.

• Develop strategies to optimize warehouse operations and improve efficiency.

• Establish priorities for raw material (RM) and single-use process consumables procurement in collaboration with operations teams.

• Track and manage inventory of RMs and GMP Supplies (including but not limited to single-use technology and product contact components).

• Manage and provide guidance to junior staff on all aspects of materials management.

Required Education, Experience and Skills:

Education:

• Minimum of bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years pharmaceutical materials management experience.

Experience & Skills:

• Demonstrated experience in a GMP-regulated manufacturing environment, ideally pertaining to biologics drug substance materials using single-use systems. 

• Prior experience of implementing or working within SAP for GMP operations or proficiency of SAP usage in biopharma environment.