Description

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 a Senior Director, Large Molecule, Analytical Development & QC on the Technical Operations team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Analytical Development & QC, you'll be responsible for shaping and executing the analytical framework for large molecules. As well you will provide strategic and operational leadership for analytical activities for developing, validating and implementing analytical strategies (method development, validation, characterization, stability) for large molecule program at Insmed from early development to Commercialization ensuring regulatory compliance (ICH, FDA, EMA) while managing internal/external labs and cross-functional collaborations.

What You'll Do:

In this role, you'll have the opportunity to use your deep technical expertise in biopharmaceutical analysis, strong leadership, and a focus on quality systems and regulatory submissions.

You'll also:

• Build and lead multidisciplinary Analytical Development and QC teams.
• Oversee analytical activities conducted at contract laboratories.
• Establish a comprehensive analytical approach for large-molecule programs, integrating characterization, method development, method validation, release and stability testing for drug substance and drug product.
• Ensure analytical approaches align with CMC development stage and evolving regulatory standards. Provide technical leadership in collaboration with internal and external stakeholders.
• Partner closely with Process Development, Manufacturing, Quality Assurance, and Regulatory functions to align analytical plans with overall program objectives.
• Support regulatory inspections by ensuring analytical systems, documentation and practices are ready for inspection.
• Oversee the out-of -specification and non-conformance investigations. Provide analytical input to deviation, root cause analyses, and CAPA development.
• Serve as a key member of the CMC/Technical Operations team, contributing to organizational process and quality culture.
• Lead the build out of new analytical laboratory, from concept to operational readiness including installation, Qualification and life cycle management of laboratory systems.

Who You Are:

You have a B.S or M.S. in Chemistry, Biochemistry or related discipline with 15+ years of experience or PhD with 5+ years of experience in the Biopharmaceutical industry.

You are or you also have:

• 5+ years of experience leadership experience including prior experience with training and mentoring other technical staff.
• Hands on experience using and interpreting data from various analytical techniques including but not limited to chromatography (HPLC, UPLC, SEC, GC, etc.), mass spectroscopy (LC-MS, GC-MS, etc.); experience with Waters/Empower is preferred. Experience with SEC-MALS and MS being advantageous.
• Strong statistical skills with a good understanding of basic and intermediate statistical tests.
• Proven track record navigating regulatory expectation for biologics (FDA, EMA, ICH).
• Excellent presentation skills both verbal and written.
• Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and quality system tool (Veeva , Trackwise).
• Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills.

Where You'll Work

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

Travel Requirements

This position involves frequent travel (up to 30%) for vendor relationships.

#LI-MC1

#LI-ONSITE

Pay Range:
$214,000.00-292,000.00 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.

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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing [email protected]; and/or
• An alternative selection process by emailing [email protected].
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at [email protected].