Senior Scientist, Analytical Development—LC/MS

Company Description

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.

Recognitions

 

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.

  

 

Qualifications

The Senior Scientist will be a part of a multidisciplinary team of scientists focused on the analytical procedure development, pre-formulation development, and characterization of ground-breaking gene therapy products. They will act as a primary liaison between R&D and Analytical Development for development and transfer of research LC/MS methods into the CMC space prior to and in support of the elevation of a drug candidate from R&D to CMC full development status. They will collaborate with R&D and may assist with non-clinical biomarker quantification and testing efforts to ensure an appropriate patient biomarker monitoring. Support all CMC characterization LC/MS related method development and product quality attribute characterization is authored into IND(a) and BLA submissions for Insmed Gene Therapy products. They will be involved in aligning with the MS Core lab based out of Bridgewater, New Jersey to evaluate, select, acquire and implement the appropriate MS solutions to meet the needs of Gene Therapy programs. They will be involved in developing and running LC/MS based methods for characterization. The Senior Scientist will also develop, improve, implement, transfer and co-validate LC based assays with a receiving laboratory (QC internal/external). They will be involved in supporting process development activities with LC assay development and testing (2D-LC method development likely) and participate in CMC team and governance team activities as an SME. 

• The Senior Scientist will specialize in LC/MS-based analytical development for large molecules, with a focus on groundbreaking gene therapy products such as AAV vectors and other complex biologics."

• Large molecule intact mass analysis, such as VP1, VP2, and VP3, familiarity with instruments Q-TOF, MS/MS or equivalent systems

• May serve as a liaison with R&D for non-clinical/clinical biomarker LC-MS related needs.

• Serve as a subject-matter-expert for all HPLC and LC/MS based method development and testing.

• Participates as an Analytical Lead on Product Development Teams and Global Asset Teams as needed.

• Be accountable for execution of program development from technical development, through manufacturing operations and culminating in the successful preparation of regulatory submissions.

• Protein identification, quantification and characterization from the therapeutic evaluation of our compounds in preclinical development studies.

• Summarize experimental data into technical reports and for external publications.

• Present scientific results to the larger Insmed research and technical operations groups, and external scientific community, as needed.

• Present scientific results to the R&D and Technical Development teams and periodically at scientific conferences in poster or podium format.

• Maintain proper documentation of experimental procedures and results via electronic laboratory notebook.

• Maintain specific laboratory equipmen