Senior Scientist, Analytical Development - Small Molecule at Insmed Incorporated in Research Development Lab - New Jersey

Job description

• We’re looking for a Senior Scientist, Analytical Development on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Analytical Development, you’ll lead analytical development efforts for small-molecule drug substances and drug products. This role will support early- to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline toward clinical and commercial success.

Responsibilities

• In this role, you’ll have the opportunity to lead the development and optimization of analytical methods for starting materials, intermediates, drug substances, and drug products. You’ll also:
• Utilize a wide range of analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications.
• Design and lead method validation activities to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines.
• Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.
• Prepare, review, and approve technical documents, including standard operating procedures (SOPs), analytical methods, protocols, reports, and product specifications.
• Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.
• Collaborate with process chemistry, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.
• Lead or contribute to cross-functional project teams, manage analytical development timelines, and communicate progress to stakeholders.
• Serve as the Analytical Lead for CMC programs, overseeing analytical deliverables, including method development, validation, and GMP testing for both internal teams and external partners.
• Manage and oversee external service providers supporting analytical development activities, ensuring timely deliverables and continuous process improvements.
• Provide technical troubleshooting, data interpretation, and review of analytical data, including method validation documents, Certificates of Analysis (CoAs), and stability reports.
• Lead the design and development of phase-appropriate quality control strategies, specifications, and stability programs for drug substances and drug products.
• Contribute to CMC operations, including execution, process improvements, and development of operational capabilities.
• Collaborate with cross-functional teams across the organization to establish and enhance technical and business practices.
• Perform additional responsibilities as assigned to support evolving departmental needs.

Requirements

• You have a bachelor’s degree in chemistry, Biochemistry, or related discipline with 6+ years of experience, or master’s degree with 4+ 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.

Skills

Required

• Collaboration
• Accountability
• Passion
• Respect
• Integrity
• HPLC
• GC
• LC-MS
• NMR
• UV
• FTIR
• ICH

Benefits

• At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
• Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
• $127,000.00-165,500.00 Annual