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

Named Science’s 2021 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 were named the No. 1 company to work for in the biopharma industry in Science’s 2021 Top Employers Survey.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In June 2022, we were listed as one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in New York, New Jersey, and Connecticut.

Overview

The Sr. Scientist of Analytical Development will have expert skills in pharmaceutical analytical chemistry and method development. The ideal candidate is expected to lead the analytical development of large molecule candidates from discovery through NDA for both drug substances and drug products. They must possess a deep understanding of the pharmaceutical development process from pre-clinical development through life-cycle management. The selected candidate will engage with cross-functional teams seeking to develop methods in support of new chemical entities to support Insmed’s platform.

• This position reports directly to the Associate Director, Analytical development
• This is a not a supervisory position
• This role oversees vendors and/or contractors.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• Acts as an analytical SME for internal product development using traditional and advanced analytical techniques including but not limited to HPLC, UPLC, GC, Dissolution, IVRT, LC-MS, GC-MS, XRPD, Raman, FTIR, Microscopy, PSD, Viscosity, etc.
• Interprets complex data and solves scientifically challenging problems by providing direction to the AR&D Laboratory.
• Interacts with internal partners, CMOs and contract laboratories during the technology transfers of analytical methods, clinical batch testing, stability testing and CMC compilation of assigned projects.
• Able to evaluate, design and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3).
• Collect, analyze, and document results and prepare study reports.
• Communicate results of experiments with the potential to present findings to the project team.
• Able to work in a fast-paced, team-oriented environment to accelerate early drug development.
• Demonstrate familiarity with QBD approach to provide analytical support to drug substance and drug product manufacture.
• Closely coordinate with QA and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing.
• Manages contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve if needed.
• Communicating potential issues/obstacles and escalating, as necessary.
• Able to determine priority of urgent items and appropriate action plan to effectuate priority.
• Cross-functional liaison working closely with internal stakeholder.

Qualifications

About You:

• MS in Chemistry, Biochemistry, or related discipline with 15 years of experience or PhD with 10 years of experience in the pharmaceutical industry, specifically CMC.
• Hands on experience using traditional and advanced analytical techniques is required.
• Good understanding of cGxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements.
• Ability to define problems, collect data, establish facts, and draw valid conclusions is required.
• Ability to establish and maintain cooperative working relationships with internal and external partners is required.
• Ability to take initiative and work independently while effectively managing timelines is required.
• Excellent presentation skills both verbal and written.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Must successfully exhibit Insmed’s five (5) core values of Collaboration, Accountability, Passion, Respect and Integrity along with any other position specific competencies.

Travel Requirements

Up to 10% travel, both domestic and/or international.

Additional Information

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.

If you need a reasonable accommodation for any part of the employment 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.

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.