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Production Supervisor
2 months ago
Job Summary:
We are seeking a highly skilled Manufacturing Supervisor to join our team at Lyra Therapeutics, Inc. As a key member of our manufacturing operations, you will be responsible for ensuring the effective use of materials, equipment, and personnel to produce high-quality products while meeting build schedules and customer demands.
Key Responsibilities:
- Author and revise Standard Operating Procedures (SOPs), batch records, deviations, investigations, and training materials to support continuous improvement of manufacturing processes.
- Collaborate with manufacturing personnel to identify opportunities for operational process improvements using Lean Principles.
- Work closely with cross-functional teams, including MSAT, Regulatory, Quality Control, and Quality Assurance, to ensure compliance with Good Manufacturing Practices (GMP) regulations and data integrity.
- Facilitate cross-functional meetings and discussions to gain alignment and resolve issues.
- Train Manufacturing Supervisors and Manufacturing Technicians/Operators on document revisions.
- Support MSAT/Engineering on the writing and execution of validation plans.
- Review completed batch records as needed to support production supervisors.
- Ensure operations and practices comply with established procedures and cGMP regulations.
- Acquire technical expertise on regulatory requirements as it relates to manufacturing.
Requirements:
- Bachelor's Degree in an Engineering, Science, Statistics, Math, IT (Software Development, Engineering), Data Scientist, or related field.
- Minimum of 3 years of experience in pharmaceutical or medical device manufacturing or a similar regulated industry with prior exposure to FDA 21 CFR 210/211, FDA 21 CFR 820, or ISO 13485 requirements.
- Preferred experience with bioresorbable polymers, device manufacturing, validations, and scale-up.
- Strong technical writing and computer skills.
- Strong project management and communication skills, including experience presenting in front of multidisciplinary stakeholders.
- Ability to work effectively in a collaborative team environment.
- Proven ability to execute and follow-through to completion.
About Lyra Therapeutics:
We are 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. Our team is growing, and we are seeking a Manufacturing Supervisor to join our fast-paced, high-performing team.
