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.

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.
• 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 equipment.
• Responsible for defining and authoring defensible LC-MS based characterization strategies for regulatory interactions (briefing books, etc.) and filings (INDs/BLAs).  May act as an SME during interactions with health authorities.
• Define and implement state-of-the art technology to support non-clinical and clinical bio-marker and product quality characterization needs.
• Write and review protocols, SOPs, reports and other product development documents
• Conceptualize, construct, validate, and implement screening platforms to enable biomarker discovery and screening in tissue samples.
• Perform data review to ensure accuracy, completeness, and validity.
• Participate in cross-disciplinary mentoring and training of entry-level and junior scientists.
• Assist with coordination and day-to-day management of site operations.

Requirements:

• PhD in biochemistry, analytical chemistry, bioengineering, or related field with 6+ years of postdoctoral experience including AAV biomarker and AAV product quality method development.
• Deep technical understanding of and hands-on experience with LC-MS and other protein biochemistry with routine protein characterization methods including but not limited to spectroscopy, capillary electrophoresis, SDS-PAGE, western blot, and ELISA techniques.
• Expertise with triple quad (Sciex 7500 a plus) as well as QTOF or Orbitrap mass spectrometry (Q-exactive a plus).
• Large molecule intact mass analysis, such as VP1, VP2, and VP3, familiarity with instruments Q-TOF, MS/MS or equivalent systems.
• Proven track record in methods development, including experimental design, execution, and evaluation.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Strong analytical and problem-solving skills.
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Integrity, Collaboration, Accountability, Passion, and Respect; along with any other position specific competencies.
• The successful candidate will thrive in a dynamic work environment and show a commitment to diversity in individuals and ideas.
• May require Domestic and/or International travel up to 20%.

• May require Domestic and/or International travel up to 20%

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 information 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.