Senior Scientist, Analytical Development (Large Molecule)

Insmed Incorporated • Research Development Lab - New Jersey, NJ

1d • Onsite

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, 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.

Requirements

• 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.
• 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.
• 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.

Nice To Haves

• 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.
• Working knowledge of half-life extension methods such as PASylation and PEGylation.
• Experience with SEC-MALS and MS being advantageous.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior