Manufacturing Supervisor
12 hours ago
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our team is growing, and we are seeking a skilled Manufacturing Supervisor to oversee the effective use of resources, equipment, and personnel in producing high-quality products, meeting production schedules, and providing guidance and support to the work group to achieve assigned objectives.
Key Responsibilities:- Develop and maintain Standard Operating Procedures (SOPs), batch records, deviations, investigations, and training materials to support continuous improvement of manufacturing processes for combination pharmaceutical and medical device products.
- Collaborate with manufacturing personnel to identify opportunities for operational process improvements using Lean Principles and 5S methodologies.
- 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 related to manufacturing.
- Establish and foster strong collaborative relationships with internal and external partners and service providers.
- Bachelor's Degree in an Engineering, Science, Statistics, Math, IT (Software Development, Engineering), Data Science, or related field is preferred.
- 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 to multidisciplinary stakeholders.
- Ability to work effectively in a collaborative team environment.
- Proven ability to execute and follow through to completion.
- Be a champion of a highly collaborative, transparent, data-driven, and 'make it happen' culture.
At Lyra Therapeutics, we value creativity, leadership, and collaboration. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high-performing team. If you are a driven, innovative, and adaptable individual, please submit your cover letter and CV for consideration.
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