Immunome

Antibody-based therapeutic discovery and development

Bioanalyst

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBothell, WA, USA$120.2k - $142kIn-person

About the Job

Requirements

A minimum of 5 years of experience in the pharmaceutical or biotechnology industry in a regulated bioanalytical environment, preferably across multiple modalities including small molecules, large molecules, and antibody-drug conjugates.
A minimum of 3 years of experience managing relationships with global bioanalytical vendors, including contract research organizations.
Familiarity with current global bioanalytical regulatory guidance.
Regulated laboratory experience with Good Laboratory Practice, Good Clinical Laboratory Practice, and ICH M10.
Hands-on bench-level experience with method development, validation, and troubleshooting, including ligand-binding assays and/or liquid chromatography-tandem mass spectrometry.
Demonstrated experience supporting clinical and regulatory development of bioanalytical requirements and GxP regulations, with working knowledge of the regulatory process.
Experience developing and executing bioanalytical plans to support clinical development.
Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities.
Ability to oversee multiple projects simultaneously in a fast-paced environment.
Ability to communicate complex information succinctly in writing and orally.
Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams.

Responsibilities

Develop and implement bioanalytical assays for compounds in clinical development, including providing scientific and technical oversight of contract research organizations performing bioanalytical laboratory work and ensuring scientific and regulatory compliance.
Act as the primary contact for external vendors and maintain working relationships with them to facilitate execution of bioanalytical strategies.
Partner with other functions and departments to ensure programs progress seamlessly through development and ensure bioanalytical subject-matter expertise is represented on cross-functional project teams.
Author relevant sections of clinical study protocols, analysis plans, reports, and regulatory submissions, including Investigator's Brochures, Common Technical Documents, Investigational New Drug applications, and Biologics License Applications.

Desired Qualifications

Experience in a regulated bioanalytical environment preferably includes work across multiple modalities, including small molecules, large molecules, and antibody-drug conjugates.

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

Join Our Experienced, Passionate Team

Working at Immunome gives you the opportunity to make a difference in the lives of cancer patients, contribute to developing best-in-class targeted cancer therapies, and work with some of the brightest and most experienced minds in antibody-drug conjugate (ADC) development.

Immunome’s office is charged with the collective excitement and passion of people working together to develop life-changing cancer medicines. Our team thrives in an innovative, collaborative environment where employees are empowered to do their best work.

Immunome also offers a comprehensive benefit program for you and your family, including:

Medical, dental, and vision insurance coverage for employees and their dependents, including 100% company-paid medical premiums for employees
A 401(k) with employer match
Employer-paid life insurance, short- and long-term disability insurance, and AD&D
Paid time off, company holidays, and a week-long winter break between Christmas and New Years.
Paid parental leave

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).

Washington State Pay Range 120200 - 141960 USD

About the Company

Immunome

Antibody-based therapeutic discovery and development

Immunome identifies antibodies and their targets by studying the immune systems of patients who recover from diseases, to develop first-in-class therapeutics. Its platform analyzes immune responses to discover novel antibodies and their targets, which are then advanced through research and development in partnership with healthcare and medical research clients. The company’s products work by using antibodies discovered from patients’ immune systems to target diseases, potentially enabling new treatments across oncology and other areas. Immunome differentiates itself through a proprietary discovery platform that extracts clinically relevant antibodies from real patient immune responses, enabling collaborations and licensing deals rather than solely pursuing standalone drug sales. The goal is to bring new antibody therapies to patients by forming partnerships, licensing innovations, and eventually delivering approved therapies.

Company size: 201-500
Company stage: IPO
Headquarters: Bothell, WA
Founded: 2008

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