Senior Scientist

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Job description

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.

Overview

We are seeking a motivated and experienced Senior Scientist to join our Analytical Development team. The ideal candidate will have a strong background in pharmaceutical analytical chemistry and method development, with the ability to contribute to drug development from discovery through NDA submission for both drug substances and drug products. This role will primarily focus on analytical method development for small molecule candidates and involve working in our internal laboratory, as well as overseeing activities at external contract labs. Experience with inhalation products is a plus. The position requires a deep understanding of the pharmaceutical development process and the ability to collaborate cross-functionally in support of various dosage forms. This is not a supervisory position.

Responsibilities

• Take the analytical lead for small molecule products (inhalation combination products, tablet formulations, and oral solutions) from early-stage development through to Phase III and commercialization.
• Develop and validate analytical methods using advanced techniques (e.g., HPLC, UPLC, LC-MS, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.
• Apply phase-appropriate strategies for method development and validation, tailored to the requirements of early-stage clinical trials through to late-stage and commercial phases.
• Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.
• Oversee the technology transfer of analytical methods to CMOs and external contract laboratories. Ensure robust method transfer for clinical batch testing and stability studies.
• Ability to conduct risk assessments and develop analytical methods for the detection and control of nitrosamine impurities, ensuring compliance with regulatory guidelines.
• Lead pre-formulation and stability studies for small molecule drug products to assess their shelf life and ensure product quality during development and commercialization.
• Analyze complex data, identify potential issues in analytical methods or product quality, and propose scientifically sound solutions to overcome technical challenges.
• Prepare technical documents such as protocols, development reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.
• Contribute to regulatory filings (IND, NDA, ANDA), including providing the necessary analytical data and documentation required for submissions to global health authorities.
• Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.
• Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.
• Contribute to a fast-paced, team-oriented environment focused on accelerating early-stage drug development.

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

• Bachelor's degree in Chemistry, Biochemistry, or related discipline with 10+ years of experience, or MS with 6+ years of experience.
• Hands-on expertise in analytical method development for solid oral and liquid dosage forms. Experience with inhalation and combination products is preferred.
• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
• Strong commitment to laboratory work with meticulous attention to detail.
• Advanced proficiency in Microsoft Office tools.
• Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel: Minimal Travel

Salary Range

$111,000 - $156,133 a year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.

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 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.

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

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