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.

 

The Research Associate, under the direct supervision of the Laboratory manager, will assist in activities to support and grow the analytical development within the organization. These activities include, but may not be limited to instrument qualification, computer system validation, technical writing, and support of laboratory operations and quality systems. The candidate must demonstrate knowledge of Commissioning, Qualification, and Validation (CQV) regulatory requirements and documentation deliverables. The candidate will possess strong oral and written communication skills and actively contribute to training, report generation and GMP documentation. This position will interface regularly and build relationships with each team member and other functions to drive success of the activities and projects while maintaining the highest quality and integrity standards.

Responsibilities (Essential Role Responsibilities):

• Support/Lead Commissioning, Qualification, and Validation (CQV) projects within the Analytical Development Department.
• Author/Review CQV deliverables including User Requirement Specifications (URS), Validation Plans, Change Controls, Qualification Protocols, Functional Risk Assessments, Configuration Specifications and Validation Summary Reports.
• Perform Installation, Operation, and Performance Qualification (IOPQ) activities as needed.
• Serve an active role in CSV activities including, but not limited to, author and review of relevant CSV documents.
• Perform data integrity risk assessments for laboratory instruments and software.
• Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
• Author SOPs, study protocols, investigation reports, and study reports.
• Demonstrate strong oral and written communication skills.
• Performs sample testing and data analysis following established methodologies
• Collaborate across multiple cross- functional teams to perform experiments and summarize work in presentations and technical reports.
• Able to work in a fast-paced, team-oriented environment with accelerated timelines.

Position Requirements (Required and/or Preferred Skills, Experience and Education)

• Bachelor’s degree in Chemistry or a related field from an accredited college
• 2+ Relevant industry experience may be considered in lieu of the above requirement
• Must have strong communication skills.
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Good understanding of GxP, CMC, ICH, ISPE and compendial (USP/EP/JP) regulatory requirements.
• Experience with cleaning validation, utility systems validation, laboratory systems and equipment, temperature mapping, etc.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Proficiency with additional software like Veeva EDMS, Microsoft Projects, Minitab, and Workday is a plus.
• Must successfully exhibit Insmed’s five (5) core values of Collaboration, Accountability, Passion, Respect, and Integrity along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

$88,000 - $122,467 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.