Company Overview
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.
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).
Skills Required
- At least 5 years of experience in the pharmaceutical or biotechnology industry in a regulated bioanalytical environment
- At least 3 years of experience managing relationships with global bioanalytical vendors or CROs
- Familiarity with current global bioanalytical regulatory guidance
- Experience in regulated laboratories, including GLP, GCLP, and ICH M10
- Hands-on bench-level experience with method development, validation, and troubleshooting
- Experience with ligand-binding assays and/or LC-MS/MS
- Experience supporting clinical and regulatory development of bioanalytical requirements
- Working knowledge of GxP regulations and the global regulatory process
- Experience developing and executing bioanalytical plans for clinical development
- Experience authoring sections of global regulatory submissions and interacting with health authorities
- Experience with multiple modalities, including small molecules, large molecules, and ADCs
What We Do
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. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
