Prinicipal Bioanalyst jobs in United States
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Immunome, Inc. · 8 hours ago

Prinicipal Bioanalyst

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The Principal Bioanalyst will be responsible for developing and implementing bioanalytical assays to support clinical stage bioanalysis for candidate drugs, ensuring scientific and regulatory compliance while collaborating with various departments and external vendors.

BiopharmaBiotechnologyMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Develop and implement bioanalytical assays for compounds in clinical development. This includes scientific and technical oversight of CROs performing the bioanalytical lab work as well as ensuring scientific and regulatory compliance
Act as the primary contact and maintain working relationships with external vendors to facilitate execution of bioanalytical strategies
Actively partner with other functions and departments to ensure that programs are progressed seamlessly through the development process; ensure bioanalytical subject matter expertise is represented in cross-functional project teams
Author relevant sections of clinical study protocols, analysis plans, reports and regulatory submissions (such as IBs, CTDs, INDs, BLAs)

Qualification

Bioanalytical assay developmentRegulatory complianceMethod validationLC-MS/MSVendor managementInterpersonal skillsProblem-solving skillsCommunication skillsCollaboration skills

Required

A minimum of 7+ years' experience in pharmaceutical/biotechnology industry in a regulated bioanalytical environment, preferably with multiple modalities, including small molecules, large molecules, and ADCs
A Bachelor's or Advanced Degree in Biology, Chemistry, Biochemistry, or a related field
Familiarity with current global bioanalytical regulatory guidance
History of hands-on bench-level experience with method development, validation, and troubleshooting is required. (Ligand-binding and/or LC-MS/MS)
Experience managing relationships with global bioanalytical vendors (CRO's) is required
Previous work with anti-cancer agents, ADCs, is required
Demonstrated experience supporting clinical and regulatory development of bioanalytical requirements, GxP regulations, with excellent working knowledge of the regulatory process
Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment
Demonstrated experience in the development and execution of bioanalytical plans to support clinical development
Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly
Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities
Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams

Company

Immunome, Inc.

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Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

H1B Sponsorship

Immunome, 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
2025 (1)

Funding

Current Stage
Public Company
Total Funding
$998.85M
Key Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M

Leadership Team

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Clay Siegall
President and CEO
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Purnanand D. Sarma
President & CEO
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Recent News

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