Senior Scientist, Drug Product Development jobs in United States
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Immunome, Inc. · 5 days ago

Senior Scientist, Drug Product Development

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The Senior Scientist, Drug Product Development will lead formulation and drug product development for the ADC pipeline, establishing lab capabilities and executing formulation studies in a fast-paced environment.

BiopharmaBiotechnologyMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Lead formulation development for antibody and ADC drug products, including stability-indicating formulation screening and optimization for early and late stage products
Design, develop (internally and/or externally), and tech-transfer drug product processes including lyophilization, for ADC drug products to ensure manufacturability, and scalability
Support building internal formulation lab capabilities, including equipment selection
Serve as the internal subject matter expert (SME) for DP formulation and lyophilization, guiding both internal scientists, as the team expands, and external CDMOs
Collaborate closely with ADC DS Development, Analytical Development, QC and QA teams to ensure end-to-end alignment across CMC
Author and review CMC documentation, including development reports, regulatory submissions (IND/IMPD/BLA), and technical transfer packages
Evaluate and implement emerging technologies for ADC formulation and lyophilization to drive innovation and efficiency
Mentor and develop junior scientists as the team expands

Qualification

ADC formulation developmentLyophilization cycle developmentFormulation screeningAnalytical data interpretationCMC principles understandingRegulatory requirements knowledgeCommunication skillsCollaboration skillsLeadership skillsProject management

Required

A minimum of a of industry experience in biologics or ADC formulation and lyophilized drug product development
Proven expertise in lyophilization cycle development, characterization, and scale-up for biologics
Strong hands-on experience in formulation screening, stability studies, and analytical data interpretation
Demonstrated experience establishing or operating in an internal lab environment
Excellent understanding of CMC principles and regulatory expectations for biologic and ADC drug products associated to the products' phase
Deep understanding of formulation principles for biologics and ADCs, including critical quality attributes (CQAs), thermal stability and compatibility considerations
Proficiency in fill/finish and lyophilization process development, scale-up, optimization, tech-transfer and troubleshooting
Strong analytical skills for interpreting data from formulation and stability studies
Working knowledge of regulatory requirements for clinical and commercialization of sterile drug products, including application of Quality by Design principles
Excellent communication and collaboration skills to work cross-functionally and with external partners
Ability to innovate and implement emerging technologies in drug product development
Ability to manage multiple projects with tight deadlines and priorities
Leadership skills to mentor junior scientists and/or manage projects effectively

Preferred

Experience with ADCs and establishing internal lab is preferred

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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