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).
