Process Control Specialist

6 days ago


Watertown, Massachusetts, United States Lyra Therapeutics Full time

About Us

Lyra Therapeutics is a dynamic biotechnology company that is committed to making a difference in the lives of patients suffering from chronic diseases.

Job Description

We are seeking an experienced Manufacturing Supervisor to join our team and contribute to the development of innovative solutions for the treatment of chronic diseases.

Key Responsibilities

  • Manage the production process to ensure compliance with regulatory requirements and implement quality control measures.
  • Work closely with the manufacturing team to identify areas for improvement and implement process changes to increase efficiency and productivity.
  • Develop and implement 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 MSAT, Regulatory, Quality Control, and Quality Assurance groups to ensure compliance with GMP regulations and data integrity.

Requirements

  • Bachelor's Degree in an Engineering, Science, Statistics, Math, IT (Software Dev, Engineer), Data Scientist or related fields is preferred.
  • Minimum of 3 years of experience in pharmaceutical or medical device manufacturing or 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.
  • Be a champion of a highly collaborative, transparent, data-driven, and a 'make it happen' culture.

Salary and Benefits

We offer a competitive salary range of $80,000 - $120,000 per annum, depending on experience, plus benefits and opportunities for growth and development.



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