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 Scientist, Analytical Development (Large Molecule) on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Manager, Large Molecule Analytical Development , you'll be responsible for managing the internal analytical laboratory and overseeing analytical activities conducted at CROs/CDMOs. This includes method development, qualification/validation, method transfer, and characterization of drug substances, drug products, support release and stability testing.

What You'll Do:

In this role, you'll have the opportunity to serve as the analytical subject matter expert (SME) for internal product development, employing a range of analytical techniques such as chromatography (HPLC, UPLC, SEC), Electrophoresis, ELISA based methods and other standard methodologies to support preclinical stage large molecule projects. You'll also:

• Lead method development, analytical testing and method qualification initiatives, encompassing protocol preparation, SOP review, technical report generation, and memo composition.
• Develop and implement methodologies and strategies for the quantitation, characterization, and stability testing of drug substances and drug products.
• Hands on experience and deep understanding of techniques like Peptide mapping, HPLC/UPLC (IEX, SE, RP), SEC-MALS, DLS, DSC, CD & CE-SDS along with impurity assays for HCP, residual Protein A, residual host cell DNA, Bioburden and Endotoxin detection.
• Responsible to develop bio-analytical methods for testing and characterization of protein therapeutics such as ELISA, SPR, BLI and various cell-based assays.
• Overviewing and generating reliable and interpreting data, using analytical instruments that include plate-readers, UV/Vis spectrophotometers, cell-counters, RT-PCR and microscope.
• Design and execute experiments to characterize biochemical and biophysical properties of protein therapeutics.
• Collaborate efforts in protein engineering to optimize stability, solubility, and other critical properties
• Able to evaluate, design and perform method development and qualification employing phase-appropriate approaches at different stages of development
• Working knowledge of half-life extension methods such as PASylation and PEGylation
• Maintain accurate, detailed, and timely notebook records of method development and analytical data
• Able to manage authoring of analytical sections of INDs, CTAs, BLAs, health authority responses and participations in regulatory interactions
• Interact with internal partners, CROs and contract laboratories during the development of analytical methods, stability testing, and preparation or overview of technical transfer documents
• Cross-functional liaison working closely with internal stakeholders, including communication of potential issues/obstacles
• Present scientific results to the cross-functional teams
• Serves as the analytical development SME of large molecule for internal and external cross-functional projects. This position will build strong relationships with external vendors to learn and evaluate new and upcoming technologies, including scheduling lunch-and-learns.

Who You Are:

You have a B.S in Chemistry or Biochemistry with 8 years, M.S with 6 years or PhD with 3 years of experience in the biopharmaceutical industry.

You are or you also have:

• Ability to define problems, collect data, and draw valid conclusions.
• 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.
• Good understanding of GxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements.
• Excellent presentation skills both verbal and written.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Must successfully exhibit Insmed's five (5) core values of Collaboration, Accountability, Passion, Respect, and Integrity along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Knowledge of laboratory safety and quality control practices

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

Pay Range:
$127,000.00-165,500.00 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.

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 TotalRewards@insmed.com 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 TotalRewards@insmed.com; and/or
• An alternative selection process by emailing Privacy@insmed.com.
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.