Senior Scientist, Analytical Development - Large Molecule

Compensation

$127,000.00 - $127,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Job 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 on the Large Molecule Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Large Molecule Analytical Development & QC 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. You'll work closely with a multidisciplinary team of scientists dedicated in developing innovative protein drug candidates.

What You'll Do:

In this role, you'll have the opportunity to lead activities related to the development, optimization, and qualification of analytical methods supporting biologics R&D projects. You'll also:

Serve as the analytical subject matter expert (SME) for internal product development, employing a range of analytical techniques such as chromatography, electrophoresis, mass spectrometry, and other standard methodologies to support preclinical stage large molecule projects

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, release/stability and in-process testing of drug substances and drug products using techniques like Peptide mapping, HPLC/UPLC (IEX, SEC, RP), SEC-MALS, DLS, DSC, CD & CE-SDS, icIEF, LC-MS, MS/MS, MALDI

Design and execute experiments to characterize biochemical and biophysical properties of protein therapeutics

Collaborate efforts in R&D 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, including in-process testing

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 participation in regulatory interactions

Interact with internal partners, CDMO and contract laboratories (CRO) 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 and present scientific results to the cross-functional team

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 PhD and 2 years of experience in biopharmaceutical industry OR Master's and 4 years of experience in biopharmaceutical industry OR Bachelor's and 6 years of experience in biopharmaceutical industry.

You are or you also have:

Advanced expertise in bioanalytical chemistry and method development

Hands on experience using and interpreting data from various analytical techniques including but not limited to chromatography (HPLC, UPLC, GC, etc.), mass spectroscopy (LC-MS, MS/MS, etc.)

Comprehensive understanding of the pharmaceutical development process from pre-clinical stages through life-cycle management

Ability to define problems, collect data, and draw valid conclusions

Strong statistical skills with a good understanding of basic and intermediate statistical tests

Good understanding of GxP, ICH and compendial (USP/EP/JP) regulatory requirements

Nice to have (but not required):

Degree in bioinformatics, computational biology, genomics, molecular biology or a similar area

Experience developing and releasing software for use by others

Experience working with structured data and SQL databases

Familiarity with popular machine learning algorithms

Experience with single-cell and/or spatial sequencing analysis (e.g., Seurat, Scanpy)

Knowledge of regulatory requirements for bioinformatics in drug development (FDA, EMA guidelines)

Familiarity with FAIR data principles and bioinformatics data standards

Familiarity with GAMP5 framework and risk-based software validation approaches

Experience with Waters/Empower, SEC-MALS and MS

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

This role requires occasional domestic/international travel (approximately 5%-15%).

#LI-POST

#LI-MC1

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. 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.

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjc3NjExLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t

Place of Work

On-site

Requisition ID

R3722-3486