Manager, Quality Control Position Available In Somerset, New Jersey

Job Description:

Company Description Insmed is a global biopharmaceutical companyon a mission to transform the lives of patients living with seriousand rare diseases. Our most valuable resource is our employees, andeverything we do is motivated by a patients-first mentality. We arededicated to growing our team with talented individuals from aroundthe world who are willing to challenge the status quo, solveproblems, and work collaboratively with a sense of urgency andcompassion. Guided by our core values of collaboration,accountability, passion, respect, and integrity, we aim to fosteran inclusive, diverse, and flexible work environment, where ouremployees are recognized for leaning in and rolling up theirsleeves. If you share our vision and want to work with the mostdedicated people in the biopharma industry, come to Insmed toaccelerate your career. Recognitions Consistently Ranked Science ‘sTop Employer Insmed is dedicated to creating a collaborativeenvironment where our team can thrive. Every day, our employeesturn their passion for science and research into innovativesolutions for patients. That’s why we’ve been named the No. 1company to work for in the biopharma industry in Science ‘s TopEmployers survey for four years in a row. A Certified Great Placeto Work® We believe our company is truly special, and our employeesagree. In July 2024, we became Great Place to Work-certified in theU.S. for the fourth year in a row. We are also honored to have beenlisted on the Best Workplaces in Biopharma™, Best Workplaces in NewYork™, PEOPLE® Companies That Care, Best Workplaces for Women™,Best Workplaces for Millennials™, and Best Medium Workplaces™lists. Overview The Manager of Quality Control will serve as astrategic and tactical quality professional in ensuring oversightand execution of all aspects of commercial GMP related analyticaltesting, as well as late stage GMP development testing. Responsiblefor ensuring oversight of contract laboratories and testingperformed by manufacturers of all commercial and late stagedevelopment products, including starting materials, in-process,release, and stability testing throughout the product lifecycle.

Accountable for assemble, review and trending the release, IPC, andstability data. This role supports Insmed quality culture throughcollaborating externally and internally to ensure method transfers,method validation, and QC data integrity is established andmaintained for the late phase development and commercial programs.

Responsibilities Responsibilities Handles contract laboratoryvendors, supervises laboratory performance, assesses capability,and ensures actions are taken to improve if needed. Point personfor weekly communications with external labs for status updates andtesting activities. Measure performance against established KeyPerformance Indicators (critical metrics), thereby consistentlyensuring timely and accurate testing, reporting, and release. Thisrole will review, assemble and trend release, IPC, and stabilitydata, generating reports as necessary. Lead and assist inidentifying changes to the processes and impact on the productquality and established procedures. Ensures all Out ofSpecification / Out of Trend results are thoroughly investigatedwith root cause identified and appropriate corrective actionsimplemented. Handle method transfer, method development andvalidation activities at external lab site Notifies laboratorymanagement when unusual results, trends, or data deviations occur.

Presenting potential issues/obstacles and advancing as vital Assistin the development of new processes and process improvements.

Cross-functional liaison working closely with internalcollaborators. Statistical programming and data management supportis a plus. Develop statistical analysis plans if needed, includingthe definition of derived data sets and the design of templates forstatistical tables, figures, data listings and/or graphs forclinical summary reports. Perform statistical analyses andinterpret results of these analyses. Supply to internal developmentprojects as the need arises. Provide mentorship, support andtraining to internal / external staff as the need arises.

Requirements:

The position requires a BS or BA degree or equivalentin a science or health care field with a preferred focus onchemistry, biochemistry, microbiology, physics, science program 5years in the pharmaceutical industry with a GMP testing focus,ideally covering the analytical method and testing lifecycle fromdevelopment through commercial drug product testing. Knowledge ofQC processes and procedures and GMP regulations and mentorship withshown efficiency in maintaining QC processes for compliance withregulations. Expertise in method verification and validationprocedures. Knowledge of Statistical programming. Excellentpresentation skills both verbal and written. Ability to defineproblems, collect data, establish facts, and draw valid conclusionsrequired. Ability to establish and maintain collaborative workingrelationships with internal and external partners required. Abilityto take initiative and work independently while optimally handlingtimelines required. LI-TB1 Salary Range $111,000 – $156,133 a yearCompensation & Benefits At Insmed, we’re committed to investing inevery team member’s total well-being, now and in the future. Ourbenefit programs vary by country but we offer the following to allInsmed team members, regardless of geographic location: Flexibleapproach to how we work Health benefits and time-off plansCompetitive compensation package, including bonus Equity Awards(Long-Term Incentives) Employee Stock Purchase Plan (ESPP) For moreinformation on U.S. benefits click here . Additional InformationInsmed Incorporated is an Equal Opportunity employer. We do notdiscriminate in hiring on the basis of physical or mentaldisability, protected veteran status, or any other characteristicprotected by federal, state, or local law. All qualified applicantswill receive consideration for employment without regard to sex,gender identity, sexual orientation, race, color, religion,national origin, disability, protected Veteran status, age, or anyother characteristic protected by law. Unsolicited resumes fromagencies should not be forwarded to Insmed. Insmed will not beresponsible for any fees arising from the use of resumes throughthis source. Insmed will only pay a fee to agencies if a formalagreement between Insmed and the agency has been established. TheHuman Resources department is responsible for all recruitmentactivities; please contact us directly to be considered for aformal agreement. Insmed is committed to providing access, equalopportunity, and reasonable accommodation for individuals withdisabilities in employment, its services, programs, and activities.

To request reasonable accommodation to participate in the jobapplication or interview process, please contact us by email atTotalRewards@insmed.com and let us know the nature of your requestand your contact information. Requests for accommodation will beconsidered on a case-by-case basis. Please note that only inquiriesconcerning a request for reasonable accommodation will be respondedto from this email address. Applications are accepted for 5calendar days from the date posted or until the position isfilled.