Xeris Pharmaceuticals, Inc. · 1 day ago
Scientist I, Analytical Development
Xeris Pharmaceuticals, Inc. is seeking a Scientist I in Analytical Development to develop and implement analytical characterization methods for pharmaceutical dosage forms. The role includes collaboration with product development scientists and support for Quality Control and CMC functions in establishing product specifications and stability programs.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Develop and perform specific and selective chromatographic methods (i.e. HPLC, UHPLC, LCMS) for use in characterizing prototype pharmaceutical formulations. Where applicable, methods should be compatible with mass selective/mass spectroscopic detection
Collaborate with formulation and analytical scientists in the Product Development group to design appropriate stability programs for drug products
Proficiently configure, operate, and maintain analytical instruments including liquid chromatography systems (HPLC), Karl Fischer titrators, and particle size analyzer
Keep current with relevant literature and industry standards as applicable to research areas
Implement analytical procedures according to compendial monographs and standards (USP, EP)
Perform the duties as required for reference standard programs, instrument maintenance and calibration, and drug product stability programs
Collect, analyze, and interpret analytical instrument data while maintaining detailed laboratory records
Draft Standard Operating Procedures (SOPs) for laboratory equipment operation and maintenance
Manage external contract laboratories for method development, transfer, and QC testing
Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal and external projects)
Prepare development reports and contribute to regulatory submissions, including IND and NDA documentation
Adhere to departmental budgets and spending guidelines
Qualification
Required
A Bachelor of Science degree with 3+ years of method development experience in an industrial pharmaceutical laboratory OR MS / PhD in analytical chemistry with 1+ years of relevant industrial pharmaceutical experience
An appropriate understanding of method development, method validation, and method transfer principles
Hands-on experience and expertise with HPLC or UHPLC is a must
Demonstrated understanding of modern chromatographic theory, particularly chromatographic methods focused on Peptides, Proteins and Biologics
Ability to work effectively both independently and collaboratively within a team environment
Developing study protocols and reports with meticulous attention to record accuracy and completeness
Working knowledge of Microsoft Productivity software (Excel, Word, PowerPoint, etc.) and Agilent OpenLab
Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Strong Written and Verbal Communication skills
Preferred
Familiarity with GMP/GLP environments and understanding of FDA and ICH guidelines is a plus
Prior experience with successful regulatory submissions (IND/NDA/BLA) and commercial method support is a plus
Statistical analysis software such as GraphPad Prism, MiniTab, and JMP is a plus
Benefits
Eligibility for commission and equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
H1B Sponsorship
Xeris Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
Recent News
2026-01-09
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2026-01-03
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