Scientist II, Analytical Development jobs in United States
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Xeris Pharmaceuticals, Inc. · 18 hours ago

Scientist II, Analytical Development

Xeris Pharmaceuticals, Inc. is focused on developing innovative pharmaceutical solutions, and they are seeking a Scientist II for their Analytical Development team. This role involves developing analytical tests and characterization methods for pharmaceutical formulations, supporting Quality Control, and ensuring compliance with product specifications and stability programs.

BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Develop specific and selective chromatographic methods (HPLC, UHPLC, LCMS) for characterizing prototype pharmaceutical formulations. Methods, where applicable, should be compatible with mass selective/mass spectroscopic detection
Develop or source other methods (e.g., NMR, particle analysis, etc.) required for supporting formulation development, stability, product quality and characterization
Direct the design requirements/capabilities of new technologies required to support new product testing
Collaborate with QC to transfer methods for late-stage clinical support and registration batches
Keep current with relevant literature and industry standards as applicable to research areas
Oversee the implementation of compendial monographs and procedures (USP, EP, etc.)
Perform the duties as required for Reference Standard programs, instrument maintenance/ calibration and Stability Programs (internal and external)
Configure and operate laboratory instruments, including HPLC, LCMS, Karl Fischer Titrator, etc
Read and record instrument data, tabulate data, and keep detailed laboratory records
Draft Standard Operating Procedures (SOP’s) for advanced laboratory equipment (HPLC/UHPLC-MS) operation and maintenance
Manage external contract laboratories for methods development/characterization
Assume a lead SME role in analytical chemistry-related team roles and responsibilities (internal and external projects)
Write development reports for internal reference, relevant sections of IND, NDA, BLA and other regulatory documentation

Qualification

Analytical ChemistryChromatographic MethodsMass SpectrometryRegulatory SubmissionsMicrosoft Productivity SoftwareStatistical SoftwareWrittenTeamwork & CollaborationAttention to DetailProblem SolvingVerbal Communications

Required

A graduate degree in analytical chemistry (M.S. or Ph.D.) with a minimum of 3-5 years of relevant industrial pharmaceutical experience. A Ph.D. with relevant academic research experience may substitute for some industrial experience. Alternatively, a B.S. in Chemistry with 5-10 years of method development experience in an industrial pharmaceutical laboratory
Demonstrate understanding of modern chromatographic methods and theory, especially the chromatographic methods and theory for Proteins and Biologics
Hands-on experience and expertise with Mass Spectroscopic detectors coupled with HPLC or UHPLC
Ability to work independently as well as in a team
Prior experience with successful regulatory submissions (IND/NDA/BLA) and commercial method support
Ability to draft routine reports and maintain accurate and detailed records of work performed
Working knowledge of Microsoft Productivity software (Excel, Word, etc), Agilent ChemStation, and common statistical software like JMP and Minitab
Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications
May require periodic evening and weekend work, as necessary to meet company deadlines
Position may include periodic travel (domestic and international)
Must be able to stand for extended periods of time
Must be able to lift 25 lbs. or more
Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays, etc., and perform visual inspection for defects
Position works with potentially hazardous chemicals and active pharmaceutical ingredients
This position is based in Xeris' Chicago office and requires at least five days per week on-site

Benefits

Multiple paid time off benefits
Various health insurance options
Retirement benefits

Company

Xeris Pharmaceuticals, Inc.

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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 Company
Total Funding
$548.5M
Key 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

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John Shannon
CEO and Director
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Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
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Company data provided by crunchbase