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    Director, Manufacturing Management - Waltham, MA, United States - Lyra Therapeutics, Inc.

    Lyra Therapeutics, Inc.
    Lyra Therapeutics, Inc. Waltham, MA, United States

    2 weeks ago

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    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.

    Director, IT to serve as a functional partner to Quality and Manufacturing at Lyra Therapeutics, selecting and implementing systems from the ground up in a brand new facility.

    The position is part of a solution-centric technology team that is accountable for enabling scale across the organization by bringing both strategic expertise and operational execution to the Manufacturing and Quality functions.

    Director will focus on businesstechnology strategy development as well as program and project execution across the functions.

    This includes solution discovery, service management, risk management and relationship management ensuring strong alignment between requirements of the business and the effective planning and delivery of IT services/solutions.

    The role will collaborate closely with the aligned functional leaders to understand business strategy, demand, and priorities and help the business propose programs/projects which will drive those strategic goals.

    This position is ideal for the candidate looking for a challenging environment where leader-doers are valued and their voice is essential in setting strategy, making decisions and operationalizing both Manufacturing and Quality.

    Keep pace with the rapid growth in Manufacturing; partner with Manufacturing team to present new digital programs and represent technology solutions
    Partner closely with the Quality organization from Quality Systems to validation including Data integrity and management
    Guide Quality Control and Analytical Development through the selection, planning and implementation of a LIMs system
    Stay abreast of leading-edge digital business solutions and demonstrate the intellectual curiosity to assess and review how those technologies could and should be employed to support Lyra strategic goals
    Ensure robust business cases are developed in partnership with the senior leadership team and IT, including clear business outcomes, benefit realization, alignment to IT guiding principles and clarity on investments required
    Be accountable for, and lead a variety of, programs and projects as necessary for solution delivery
    Manage contractors, vendor partnerships and service provider relationships
    Bachelor's Degree and 15 or more years' IT experience required, including a minimum of 7 years' managing IT system implementation
    Proven track record of successfully delivering an IT strategy aligned to deliver business in an agile and exponentially growing life sciences organization (preferably, gene/cell therapy or biopharmaceutical)
    Must have a proven track-record of working in large and/or complex IT programs, with experience leading strategy development and oversight of digital transformation initiatives
    Ability to effectively facilitate interactive discussions and elicit complex business requirements in both small and large settings across audiences including business and IT professionals
    Demonstrated ability to influence the scope and direction of initiatives across multiple levels of management and organizational boundaries
    Excellent teamwork and interpersonal skills, with ability to communicate and collaborate with employees and management at all levels

    The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.

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