MSAT Engineering Manager

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.

Our team is growing, and we are currently recruiting MSAT Engineering Manager to join our dynamic team. This role represents a unique opportunity to leverage past experience and skills to launch our LYR-210 product from Waltham, our cutting-edge commercial GMP manufacturing facility, and support continued clinical production of LYR-220.

The MSAT Engineering Manager will lead a team responsible for drug products from new product launch through commercial and clinical production at Waltham and/or Watertown, MA sites. Responsibilities of this role shall include both hands-on tactical support of ongoing plant operations and strategic implementation engineering projects to meet the changing needs of the business. This involves the startup of a new commercial manufacturing site, technology transfer, and process validation. The Process Engineering Manager will report to the Director of Manufacturing Science and Technology (MSAT).

Responsibilities

• Work with cross-functional teams to drive execution of key launch/tech transfer deliverables and produce required documentation (VMP, PPQ protocol, PPQ report, etc.)
• Lead collaborations with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product (new material qualifications, new equipment qualifications, etc.)
• Be an owner of commercial and clinical product(s) and be accountable for engineering-related Change Controls, Deviations, CAPAs, and Continuous Improvements
• Resolve complex commercial manufacturing issues and provide technical support of critical process-related deviations in terms of leading root cause investigations and implementation of corrective or preventative actions
• Oversee process trending of CPPs and develop/implement CPV solutions for manufacturing. Monitor CQAs and develop/implement SPC solutions for manufacturing
• Supporting continuous validation / verification of the site Master Validation Plan and inventory of site validations
• Support site validation related activities for the design, commissioning, qualification, and continued validation maintenance of all equipment, facilities, and utilities, including identification of opportunities for improvement
• Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial readiness
• Build and lead a team of process engineering experts who will work closely together and within a highly matrixed, cross-functional team to successfully deliver business objectives
• Provide input and act as key stakeholder for design review, equipment specifications, performance criteria, success factors, budget management, and construction & installation oversight for specified capital projects

Requirements

• Bachelor’s Degree (Engineering Preferred) with 10+ years of experience. Master’s Degree (Engineering Preferred) with 8+ years of experience
• Prior experience in developing and/or managing engineers
• Experience with equipment design, commissioning, troubleshooting, etc for cGMP environment
• Understanding of engineering principles for manufacturing combination device/drug product, and/or pharma batch processes, and/or medical device Class III, spray coating mechanics, oven drying, and packaging
• Fundamental understanding and application of technology transfer and validation processes
• Prior experience in authoring & executing process validation studies for commercial GMP manufacturing processes including process qualification (IOQ, PPQ, RQ) and managing validation teams
• Strong communication (written and verbal)