Associate Director, Supply Chain Management Lead

Merck • Rahway, NJ

8d

About The Position

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.

Requirements

• 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.
• 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.
• Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), and safe operating practices for operations.
• Prior experience in people management, team performance management for shop floor activities, coordination of cross-functional warehouse teams and regulatory compliance.
• Strong focus on delivery metrics and quality adherence.
• Demonstrated proficiency in logistics, inventory management, and quality systems.

Nice To Haves

• Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team.
• Track record of working effectively with team-members of diverse skill sets and backgrounds.
• Strong verbal and written communication skills.
• Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to materials handling.
• Experience with operationalization of GMP Materials Management and warehouse operations as well as ability to work in a fast-paced environment.
• Proven self-motivation, ability to drive improvements, and inspire others.
• Strong problem-solving skills and excellent attention to detail, highly independent with initiative.
• Ability to challenge the status quo with a continuous improvement mindset.
• Ability to lift 25 lbs, if required.

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.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees