Scientist, Analytical Development

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. Thats why weve 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 Scientist to join our Analytical Development team. The ideal candidate will have a strong background in pharmaceutical analytical chemistry, with a primary focus on routine testing and GMP compliance. This role will involve performing routine analytical testing for both drug substances and drug products in our internal laboratory, ensuring adherence to GMP guidelines and industry standards. The candidate will also support analytical method development and contribute to the testing of small molecule candidates. While experience with inhalation products is a plus, the core responsibilities will include maintaining compliance with regulatory requirements, ensuring data integrity, and collaborating with cross-functional teams to meet project goals. A deep understanding of GMP, quality control processes, and the pharmaceutical development lifecycle is essential for this position. Responsibilities

• Take the responsibility for small molecule products analytical routine testing (inhalation combination products, tablet formulations, and oral solutions) from early-stage development through to Phase III and commercialization.
• Ensuring all testing is performed in compliance with GMP regulations and internal standard operating procedures (SOPs).
• Accurately recording and reporting test results, maintaining detailed and compliant documentation in accordance with GMP.
• Validate analytical methods using advanced techniques (e.g., HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.
• Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.
• 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), 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 5+ years of experience, or MS with 3+ years of experience.
• Hands-on expertise in analytical lab testing for inhalation dosage forms, 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.

Salary Range $104,000 - $137,800 a year Compensation & Benefits

At Insmed, were committed to investing in every team members 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.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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 ... 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.