- Follow and recommend improvements to all relevant internal procedures, processes and systems necessary to reliably complete GMP material related operational activities
- Complete the material related GMP activities needed to manufacture and distribute products in an efficient manner to support business and operational objectives
- Inventory Management: Maintain accurate records of materials, including receipt, storage, and issuance; monitor inventory levels to ensure sufficient stock for production needs
- Order Processing: Process purchase orders, and coordinate to ensure timely and accurate delivery of raw materials and supplies; verify the quality and quantity of material received against the purchase orders
- Material Handling: Safely handle and transport materials within the facility; adhere to proper storage conditions and ensure compliance with regulatory requirements
- Quality Control: Collaborate with the quality control team to inspect incoming materials; report any deviations and participate in investigations
- Documentation: Maintain detailed and accurate documentation related to material transactions, including batch records, certificates of analysis, and other relevant documents
- Cross-Functional Collaboration: Work closely with cross-functional teams, including production, logistics, and quality assurance, to ensure seamless coordination of materials for production schedules
- Supplier Management: Build and maintain positive relationships with material suppliers including order processing, delivery and customer service representatives; communicate effectively to address any concerns related to quality or delivery
- Safety Compliance: Adhere to safety protocols and guidelines in all material handling activities; participate in safety training programs and contribute to a culture of safety at Lyra
- Continuous Improvement: Identify opportunities for process improvement and implement best practices to enhance efficiency and reduce waste
- High school diploma or equivalent; additional education or certification in materials management or a related field is a plus
- Experience in materials management in a GMP pharmaceutical or medical device manufacturing or other regulated industry is strongly preferred
- Knowledge of Good Manufacturing Practices (GMP) and other relevant regulations
- Strong organizational and time management skills
- Attention to detail and accuracy in record-keeping
- Ability to operate material handling equipment (forklifts, pallet jacks, etc.) safely
- Effective communication and interpersonal skills
- Ability to work primarily on site in our existing facility in Watertown and our new facility in Waltham
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Materials Associate - Waltham, United States - Lyra Therapeutics
Description
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit and follow us on LinkedIn and Twitter .
Our team is growing, and we are currently recruiting for a Materials Associate to ensure uninterrupted supply of product to customers and trial sites, and to drive continuous improvement of supply chain processes and achievement of objectives. Reporting to the Materials Supervisor, areas of focus for the Materials Associate include Inventory Control, Supplier Collaboration, and Logistics and Distribution.
The role will also be responsible to maintain and quality and regulatory compliance within the cGMP environment and will interact with Quality staff to comply with Quality System Regulations and with the Finance staff to meet financial regulations.
Responsibilities
