Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

Insmed is seeking a Laboratory Systems administrator/engineer with experience in computerized systems typically used within a lab setting at both a local and global implementation scale. This individual may be responsible for establishing procedures/protocols for management of laboratory software in Insmed laboratories and will coordinate activities across multiple sites. This role may assist in equipment software qualification/validation by serving as the software and data integrity SME. Additional duties will include collaborating with contractors and consultants to support design, configuration, customization and implementation of laboratory software systems including, but not limited to: Microtiter plate analysis software, CDS [chromatography data system], LIMS [laboratory information management system]. Assignments include analytical lab support required throughout the product lifecycle for all Insmed Programs.

Representative responsibilities will include management of laboratory scientific software for analytical labs. Computer systems validation (CSV) experience is required. Experience authoring and executing CSV software validation scripts required. Experience authoring SOPs for (1) Software System Use and (2) Software system administration required. Experience with running and integrating the following software with other enterprise levels systems is required.Responsibilities:

• Administer, configure, and maintain the Lab system to meet the laboratory’s needs, including system updates, user management, and ensuring data integrity and security.
• Develop and maintain integrations between the Lab system and other laboratory instruments, systems, and databases to facilitate secure data exchange and workflow automation.
• Provide technical support to lab staff, resolving issues related to LIMS and associated systems promptly. Train users on new features and standard processes.
• Standalone Equipment software: QX Manager, Compass for Simple Western [BioTechne Jess], 32 Karat [Sciex PA800+], Softmax Pro [Molecular Devices plate readers], PLA for bioassays [Steggman System]
• CDS (chromatography database systems) such as Chromeleon and/or Empower.
• LIMS SME and Administrator: Labware LIMS with LIMS Basic coding experience a plus
• Statistical Program validation and administration—experience with JMP a plus
• Experience setting up procedural and physical controls for software that may not meet certain compliance standards.
• Experience authoring CSV related documents such as Gap Analyses, URS, risk assessments, etc.
• You may author and maintain a compliance checklist to guide the assessment process by cross-checking the company's performance against legal standards and identifying organizational gaps, weak points, and risks where adherence to rules should be tightened. May be involved in regular software audits to ensure compliance is maintained.
• Excel spreadsheet creation, use, administration and validation in a GMP setting experience is a plus.
• Maintain laboratory computerized system compliance status throughout the system lifecycle and assist in software deviation investigations.
• Manage external software consulting partners, coordinate training activities,

Position requires candidate to be on-site in San Diego, CA.Requirements:

• Minimum of 3-8 years of prior experience in lab software ownership and administration in a regulated pharmaceutical industry
• Good communication/inter-personal skills in working with business owners and contractors/consultants
• Labware LIMS administration or management required. “LIMS Basic” coding a plus, but must be willing to learn.
• Have full understanding in FDA regulations in equipment and computerized systems, especially 21CFR Part 11. Maintain robust IT security measures to protect critical data.
• Ambitious spirit, with strong willingness to tackle new challenges required to bring novel medicines to the clinic.
• Strict adherence to environmental, health, and safety guidelines

#L1-JT1

$111,000 - $156,133 a year

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more informaion on U.S. benefits click here.

 

 

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.