Senior Scientist, Analytical Development - Large Molecule
About The Position
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.
Requirements
- 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.
- 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
- Knowledge of laboratory safety and quality control practices
Nice To Haves
- Experience with Waters/Empower
- Experience with SEC-MALS and MS
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
