Bioanalyst

immunomeinc; Bothell (WA); On-site; USD 120,000 - 142,000; Full time

Job summary

Immunome, Inc. in Washington state invites a Bioanalyst to develop and implement bioanalytical assays supporting clinical-stage programs. You will oversee CRO work, ensure regulatory compliance, and partner with cross-functional teams to drive programs forward.

The role requires hands-on bench experience with method development/validation and regulatory submissions, with strong communication skills for global collaborations.

Qualifications

• A minimum of 5 years' experience in pharmaceutical/biotechnology industry in a regulated bioanalytical environment.
• A minimum of 3 years of experience managing relationships with global bioanalytical vendors (CROs).
• Familiarity with current global bioanalytical regulatory guidance.
• Regulated lab experience (GLP, GCLP, ICH M10).
• Hands-on bench-level experience with method development, validation, and troubleshooting (Ligand-binding and/or LC-MS/MS).

Responsibilities

• Develop and implement bioanalytical assays for compounds in clinical development, overseeing CRO work and ensuring regulatory compliance.
• Act as primary contact and manage relationships with external bioanalytical vendors to facilitate strategy execution.
• Collaborate with cross-functional teams to ensure bioanalytical SME representation in development programs.
• Author sections of clinical study protocols, analysis plans, reports, and regulatory submissions.

Skills

Bioanalytical experience

Vendor management

Regulatory knowledge

Multimodal analytics

LC-MS/MS

Tools

LC-MS/MS

Job description

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Bioanalyst will be responsible for developing and implementing bioanalytical assays to support clinical stage bioanalysis for candidate drugs. In this role, they will participate in the design, development, and implementation of the bioanalytical strategy for multiple oncology programs. This role reports to the Associate Director, Bioanalytical.

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).

Qualifications

• A minimum of 5 years' experience in pharmaceutical/biotechnology industry in a regulated bioanalytical environment, preferably with multiple modalities, including small molecules, large molecules, and ADCs.
• A minimum of 3 years of experience managing relationships with global bioanalytical vendors (CRO's) is required.
• Familiarity with current global bioanalytical regulatory guidance.
• Regulated lab experience (GLP, GCLP, ICH M10).
• History of hands-on bench-level experience with method development, validation, and troubleshooting is required. (Ligand-binding and/or LC-MS/MS).

Knowledge and Skills

• 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.

Washington State Pay Range

$120,200 - $141,960 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish) .