Associate Director, Small Molecule - Analytical Development

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

About the Role:

We’re looking for an Associate Director, Analytical Development, Small Molecule on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Analytical Development, you’ll be responsible for leading and overseeing analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including but not limited to oral solid, oral liquid, inhalation, and other specialized formulations. This role will provide strategic and technical leadership for analytical method development, qualification, validation, troubleshooting, and transfer activities to support product development from early-stage research through commercialization.

What You'll Do:

In this role, you’ll have the opportunity to lead analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including oral solid, oral liquid, inhalation, and other emerging technologies. You’ll also:

• Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization.
• Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations.
• Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing.
• Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages.
• Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support.
• Serve as the analytical subject matter expert for characterization of drug substances, intermediates, excipients, and drug products, including impurity profiling, degradation pathways, extractables and leachables assessments, and stability-indicating methodologies.
• Support formulation and process development activities through analytical troubleshooting, root cause investigations, and data-driven recommendations.
• Lead analytical method transfer activities between development, manufacturing, and external testing laboratories to ensure successful execution and regulatory compliance.
• Establish scientifically justified specifications and acceptance criteria for raw materials, drug substances, intermediates, and finished products throughout the product lifecycle.
• Author, review, and provide analytical content for regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and other global filings. Support responses to regulatory agency questions and inspections.
• Collaborate closely with Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing, and Project Management teams to achieve program objectives and development timelines.
• Ensure analytical activities are conducted in compliance with cGxP, ICH guidelines, USP/EP/JP requirements, and applicable regulatory standards.
• Evaluate emerging analytical technologies and industry best practices to drive continuous improvement, operational efficiency, and scientific innovation.
• Manage multiple analytical development programs simultaneously, identify technical and timeline risks, and develop effective mitigation strategies.
• Interpret complex analytical data, provide scientific leadership for problem-solving efforts, and contribute to overall CMC strategy and product development decisions.

Who You Are:

You have a Bachelor’s degree along with 10 years of experience in specifically analytical development with at least 5 years roles involving oversight of external testing laboratories. You are or you also have:

• Bachelor's degree in Chemistry, Biochemistry, or related discipline with 8+ years of experience in the pharmaceutical industry, specifically analytical development with at least 5 years roles involving oversight of external testing laboratories.
• Hands-on expertise in analytical lab testing for inhalation dosage forms and other small molecule dosage forms. Experience with inhalation and combination products is preferred.
• Strong knowledge and experience in nitrosamine risk assessment, including identification, evaluation, and control of nitrosamine impurities.
• Experience with mutagenic impurity assessment, including evaluation of potential genotoxic impurities and application of relevant regulatory guidance.
• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
• Excellent analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management.
• Effective communication skills, both verbal and written, including experience drafting regulatory responses and QC sections of submissions.
• Strong organizational and project management skills, with a focus on timeliness, quality, and compliance.
• 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.

Where You’ll Work

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

Minimal travel expected

#LI-BA

#LI-ONSITE

Pay Range:

$155,000.00-201,500.00 Annual

Life at Insmed
 

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.

Highlights of our U.S. offerings include:

• 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. 

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [email protected]  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.