MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Manager, Materials Management is responsible for the strategy and oversight of MacroGenics’ GMP materials management operations. These responsibilities include the operations and performance of GMP warehouses at both Rockville manufacturing facilities, working with Production Planning to meet anticipated manufacturing material requirements in support of product pipeline objectives, developing procedures for and overseeing MacroGenics delivery vehicle program, and developing guidelines/procedures for R&D/G&A support activities, such as general shipping/receiving.
Responsibilities and Job Duties
- Drive best practices for materials management operations including inventory management, cold chain management and performance metrics.
- Organize and prioritize staff and workload to meet or exceed productivity metrics for inbound receiving, inspection, sampling, inventory management, weigh/dispense/kitting, distribution, drug substance freeze-down/ put away, storage, and outbound shipping operations.
- Ensure execution of material flow and work practices in accordance with SOPs, cGXP, FDA, OSHA, IATA, DOT, TSA and other applicable regulations. Ensure compliance with all company and regulatory agency policies and procedures and keep department in audit-ready condition at all times.
- Coordinate with Production Planning, Manufacturing, Quality to ensure on-time availability of materials for cGMP manufacturing use. Collaborate with Production Planning, Purchasing, Supply Chain, suppliers and CMOs to ensure proper inventory management and seamless supply of materials to support internal and external production activities.
- Ensure inventory control of controlled materials by maintaining accurate inventory logs for all on-site and off-site storage locations. Author and maintain department procedures for inventory management and logistics of GMP materials.
- Initiate, investigate and close materials management quality events and implement corrective and preventative action plans to address deficient areas identified and to ensure adherence to compliance.
- Ensure operation of warehouse equipment including forklifts and pallet jacks in a safe manner compliant with OSHA standards.
- Recommend plans and strategies for continuous improvement in operating methods and procedures to meet both short and long-term needs and to resolve problems prior to or when they arise. Develop and implement protocols and practices to ensure effectiveness and efficiency of strategic initiatives an inventory/warehouse management Drive continuous improvement of the supplies movement, warehouse level optimization, kitting, and Kanban processes
- Prepare metric statistics, charts and otherreports to summarize materials management performance.
- Ensure project/department milestones/goals are met and adhere to approved budgets.
- Manage, motivate, and mentor the staff to continuously improve skills and team performance. Maintain cross-training program to assure highly-qualified backups for every function. Encourage teamwork within the materials management staff to ensure productivity goals are met or exceeded.
- Additional responsibilities to support supply chain and/or corporate activities may be necessary as designated by management.
Education & Other Credentials
- BA/BS degree or equivalent
- Valid driver’s license
- At least 5 years of progressive experience in materials management, supply chain or warehouse management within the biotech/pharmaceutical industry
- At least 2 years of prior supervisory experience (warehouse and/or material logistics)
Knowledge, Skills and Abilities
- Experience with ERP system; capable of performing, monitoring, and resolving all ERP transactions supporting the materials management function
- Strong understanding of inventory management principles and cold chain practices within GMP pharma warehouse environment
- Strong written and verbal communication skills; ability to effectively communicate to all levels of the organization
- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team based environment; ability to develop working relationships with a wide range of people
- Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
- Demonstrated skill in goal setting and driving continuous improvement through setting and monitoring of key metrics
- Knowledgeable of the current CFR, GMP, GDP and relevant ICH and FDA guidelines
- Excellent documentation and math skills
- Strong computer skills in Microsoft Office Suite
- Ability to prioritize and multi-task concurrent project demands
- Exceptional attention to detail, as well as organizational skills
- Be available on call
- Forklift certification
- IATA Dangerous Goods training and certification
- Experience with SAP ERP system
Staff of 2+ Materials Handlers at varying levels