4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a global leader in gene therapy product research and development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4DMT, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus (AAV) variants platform to treat serious unmet medical conditions.
We seek a business savvy professional who will focus on supporting Supply Chain processes and serve as liaison between Manufacturing, Facility, Quality, Technical Operations, R&D and Regulatory. In addition, you will coordinate and support material stores, logistics and materials management activities. This role will manage warehouse for GMP manufacturing and assist in manufacturing, quality, compliance and safety programs in line within defined timelines for the manufacturing/ development of products and daily operations. In addition, you will support the implementation of product & process improvements, corrective / preventative actions and change controls within procurement, sampling, testing, and release activities.
Summary Of Key Responsibilities
- Reporting to the VP of Manufacturing/Supply Chain, work with department heads to coordinate Supply Chain activities to robustly support both inhouse and CMO Clinical Manufacturing as well as R&D activities
- Manage and support the introduction of new materials and products into GMP supply chain processes and system
- Manage warehouse and coordinate the raw material transport and inventory control for off-site storage facilities including raw materials, drug substance and drug product
- Support plans for facility modifications or expansions, equipment purchases and changes in space allocation or structural design
- Provide materials management support for manufacturing, capital projects, technology transfers, and continuous improvement efforts
- Partner with material users to aid in the material replenishment processes ensuring uninterrupted material supply. Review available inventories and monitor future requirements to ensure adequate supply and facilitate material release processes with Project Management, Operations, R&D and QA.
- Represent Materials Management’s best interests on cross-functional projects and teams
- Coordinate with internal teams to predict material demands and requirements
- Support validation activities and third-party audit preparation
- Actively own and manage projects as assigned including, Continuous Improvement projects, CAPAs, Change Controls and Quality Systems as they relate to Materials Management-owned operations and processes
- Participate in regulatory and internal audits which may include direct interaction with inspectors for raw material receipt and release, scribe duties, facilitation of audit requests, and/or development of responses
- Bachelor’s degree or equivalent experience in Supply Chain Operations, Materials Management, or Business Administration and 5+ years of relevant experience in clinical/commercial biotechnology or pharmaceutical materials management, or manufacturing with experience in managing projects and manufacturing support is required
- Deep understanding of Biologic Manufacturing, Quality, Planning and Regulatory, requirements and processes in a GMP setting
- cGMP manufacturing experience preferred. Knowledge of cGMPs and applicability to manufacturing operations in a biologics or API environment is preferred.
- Experience in advanced Excel, scalable inventory software, and warehouse is needed
- Excellent interpersonal, communication, and presentation skills
- Strong leadership with excellent collaboration and relationship-building skills are critical
- Adaptable, quick learner and flexibility with work schedules required
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods in a GMP environment.
- Knowledge of principles and methods for moving goods by air or road, including the relative costs and benefits.
- Demonstrated ability of successful time management of self and others
- Knowledge of relevant equipment, policies, procedures, and strategies to promote effective operations for the protection of people, data, and property.
- Some travel may be required
Qualified candidates may submit a resume and cover letter to email@example.com