Full-Time

Associate Director / Director

Supplier Quality and Audits

Immunome

Immunome

201-500 employees

Antibody-based therapeutic discovery and development

Compensation Overview

$175.1k - $240k/yr

Bothell, WA, USA

In Person

Travel domestically and internationally up to 20%, with occasional evening or weekend commitments for audits and inspections.

Bachelor's

Category
Biology & Biotech (1)
Required Skills
ISO 9001
FDA Regulations
Quality Assurance (QA)

Get referred to Immunome

See people who can refer or advise you

Requirements
  • A bachelor’s degree in a scientific, technical, or related field is required.
  • At least 8 years of biopharmaceutical industry experience is required, including direct oversight of third parties performing GxP activities, cGMP manufacturing, testing, or clinical operations, or equivalent experience.
  • Demonstrated experience performing and managing supplier qualification and supplier audit programs is required.
  • Strong knowledge of Supplier Quality Management, GxP auditing, Quality Systems, and regulatory compliance within the biotechnology or pharmaceutical industry is required.
  • Experience managing supplier qualification, governance, quality agreements, risk assessments, and oversight of CDMOs, CROs, laboratories, and other GxP service providers is required.
  • Demonstrated experience conducting supplier audits, managing audit programs, supporting regulatory inspections, CAPA management, and inspection readiness activities is required.
  • Proven Lead Auditor experience and strong knowledge of FDA, EU, ICH, and applicable GxP regulations are required.
  • Strong understanding of cGMP manufacturing, quality assurance and control, validation, and outsourced pharmaceutical operations is required.
  • Experience developing audit schedules, audit plans, audit reports, and auditor training programs is required.
  • Ability to travel domestically and internationally up to 20%, with occasional evening or weekend commitments to support audits and inspections, is required.
Responsibilities
  • Support development and continuous improvement of Immunome’s GxP Supplier Quality and Vendor Management Program.
  • Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors and service providers.
  • Maintain supplier quality records, risk evaluations, audit reports, and performance metrics.
  • Support quality oversight of CDMOs, CROs, laboratories, consultants, and other outsourced service providers.
  • Partner with stakeholders to define and maintain vendor responsibilities and compliance expectations.
  • Lead negotiation and lifecycle management of quality agreements.
  • Plan and conduct supplier audits and follow up on responses, CAPAs, and effectiveness checks.
  • Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.
  • Monitor supplier quality performance, including deviations, CAPAs, complaints, audit findings, and service-level trends.
  • Identify, escalate, and support remediation of supplier quality and compliance risks.
  • Support cross-functional vendor governance meetings and document decisions, actions, and follow-up commitments.
  • Develop and maintain supplier quality procedures, Quality Agreement templates, and related trackers and tools aligned with Immunome’s Quality Management System and regulatory expectations.
  • Support continuous improvement of supplier quality, oversight, audit effectiveness, and inspection readiness.
Desired Qualifications
  • An advanced degree is preferred.
  • Experience supporting virtual, outsourced, or external manufacturing and service provider models is preferred.
  • Professional certifications such as ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, or RAC, or equivalent quality, auditing, or regulatory certifications, are highly desirable.

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, Washington

Founded

2008

Get referred to Immunome

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • FDA set varegacestat's PDUFA date for April 28, 2027 after strong Phase 3 data.
  • Cash and marketable securities totaled $520.0 million on June 30, 2026, funding into 2028.
  • IM-1617's first patient dosing on June 11, 2026 expands multiple shots on goal.

What critics are saying

  • IM-1617 faces AbbVie's ABBV-400 and Daiichi's crowded TOP1 ADC category by 2027.
  • Immunome burned $120.3 million cash in first-half 2026, despite $520.0 million remaining.
  • A varegacestat rejection would leave Immunome dependent on early-stage programs and recurring dilution.

What makes Immunome unique

  • Varegacestat reached FDA acceptance in July 2026, anchoring Immunome's first near-term asset.
  • IM-1617 targets an undisclosed RTK plus immune exclusion, a rare dual-mechanism ADC.
  • IM-1021 and IM-3050 broaden the platform across ADC and radioligand modalities.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Unlimited Paid Time Off

Hybrid Work Options

Flexible Work Hours

Remote Work Options

Paid Vacation

Paid Holidays

Wellness Program

Mental Health Support

Conference Attendance Budget

Professional Development Budget

Stock Options

Company Equity

Phone/Internet Stipend

Home Office Stipend

Growth & Insights and Company News

Headcount

6 month growth

21%

1 year growth

21%

2 year growth

9%
Associated Press
Aug 11th, 2026
Immunome's varegacestat NDA accepted by FDA with April 2027 target date, $520M cash reserves

Immunome reported Q2 2026 financial results, revealing a net loss of $73.1 million. The biotechnology company held $520.0 million in cash, cash equivalents and marketable securities as of 30 June, expected to fund operations into 2028. The FDA accepted Immunome's application for varegacestat, a desmoid tumour treatment, setting an approval decision date of 28 April 2027. Phase 3 trial data showed an 84% reduction in disease progression risk versus placebo. Research and development expenses totalled $59.9 million for the quarter, whilst general and administrative costs reached $18.3 million. Immunome is advancing three additional clinical-stage programmes, with first patients dosed in trials for IM-1617 and IM-3050. The company plans to submit investigational new drug applications for IM-1340 and IM-1335 by late 2026.

AllSci
Jun 12th, 2026
Immunome debuts first-in-class ADC targeting mystery immune-excluding receptor tyrosine kinase.

Immunome debuts first-in-class ADC targeting mystery immune-excluding receptor tyrosine kinase. June 12, 2026 Bothell, Washington-based Immunome, Inc. (Nasdaq: IMNM) has dosed the first patient in a Phase I first-in-human study of IM-1617, an antibody-drug conjugate directed at an undisclosed receptor tyrosine kinase (RTK) and armed with HC74, the company's proprietary topoisomerase I inhibitor payload. The trial's significance lies partly in its target biology: the RTK in question is described as promoting tumor cell survival while simultaneously mediating immune cell exclusion - a dual role that, if confirmed clinically, could position IM-1617 as relevant in immunologically cold tumors where checkpoint inhibitors have largely failed. The open-label, multicenter dose escalation and expansion study will enroll patients with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer. Primary objectives cover safety, tolerability, and pharmacokinetics, with preliminary anti-tumor activity as an exploratory endpoint. Immunome has not disclosed enrollment targets or an anticipated completion date. Two additional ADC candidates - IM-1340 and IM-1335 - are expected to reach IND submission by mid- and late 2026, respectively, signaling broader platform ambitions beyond this single asset. The rationale for IM-1617 rests on a well-documented but therapeutically underexploited observation: certain receptor tyrosine kinases do not merely sustain tumor cell proliferation but actively remodel the tumor microenvironment to prevent T-cell infiltration. The TAM family RTKs - TYRO3, AXL, and MERTK - are the best-characterized examples, functioning as innate immune checkpoints that suppress dendritic cell and macrophage activity while driving tumor cell survival through PI3K/AKT and RAS/MAPK signaling. AXL in particular has been directly implicated in T-cell exclusion in breast cancer models, where high AXL expression correlated with complete absence of immune infiltration even following radiotherapy. This biology is directly relevant to the three indications Immunome has identified. Approximately 85% of colorectal cancers are microsatellite-stable and immunologically cold, explaining why PD-1/PD-L1 inhibitors have shown no benefit in this population. A comparable subset of non-small cell lung cancers and triple-negative breast cancers similarly fail to respond to immunotherapy, not because of absent antigenicity but because immune cells are physically excluded from the tumor parenchyma. An ADC targeting the RTK responsible for that exclusion could, in principle, simultaneously kill antigen-expressing tumor cells and relieve the suppressive barrier - potentially rendering surviving tumor tissue more susceptible to endogenous or therapeutically induced immune responses. Competitive positioning. The TOP1 inhibitor ADC space is crowded at the payload level but less so at the target level, where differentiation ultimately resides. Daiichi Sankyo and AstraZeneca's DXd platform dominates across HER2, HER3, and TROP2, with multiple Phase II and Phase III assets in NSCLC and breast cancer. AbbVie is advancing ABBV-400, a c-MET-targeted ADC with a proprietary TOP1 inhibitor payload, in NSCLC and colorectal cancer - indications that directly overlap with IM-1617's target population. Because IM-1617's RTK target remains undisclosed, precise competitive mapping is not possible, but the functional description - an RTK driving both survival signaling and immune exclusion - most closely resembles AXL or MERTK biology, neither of which currently has a clinical-stage ADC program of note. Immunome's broader pipeline context is relevant here. Varegacestat, the company's gamma secretase inhibitor for desmoid tumors, has an NDA filed with the US FDA following Phase III data showing 84% reduction in progression risk and a 56% objective response rate - substantially outperforming the current standard. That near-term commercial asset provides a degree of financial and strategic runway for the ADC platform to mature. IM-1021, the ROR1 ADC sharing the HC74 payload with IM-1617, will generate the first human pharmacokinetic and safety data for HC74, which will inform dose selection and linker optimization for subsequent programs including IM-1617. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/

Business Wire
May 12th, 2026
Immunome submits NDA for varegacestat after 84% disease progression reduction in Phase 3 trial

Immunome, a biotechnology company developing targeted cancer therapies, reported first quarter 2026 financial results. The company had cash and cash equivalents of $582.7 million as of 31 March, expected to fund operations into 2028. The company submitted a New Drug Application to the US FDA in April 2026 for varegacestat, a treatment for adults with desmoid tumours. Immunome plans to submit a Marketing Authorisation Application to the European Medicines Agency by year-end 2026. Research and development expenses for the quarter were $46.4 million, whilst general and administrative expenses totalled $13.0 million. Immunome reported a net loss of $53.8 million for the quarter. The company is advancing multiple programmes, including Phase 1 trials for IM-1021 and IM-3050, and recently received IND clearance for IM-1617.

Yahoo Finance
Apr 4th, 2026
Immunome CSO sells $204K in shares ahead of Q2 2026 NDA submission

Immunome's Chief Scientific Officer Jack Higgins sold 9,438 shares on 2 April for $204,238, reducing his direct holdings by 30% to 22,000 shares. The sale was executed under a pre-arranged Rule 10b5-1 trading plan established in December 2025 for financial diversification. The transaction comes as the clinical-stage biotechnology company approaches a significant milestone: its lead candidate varegacestat met the primary endpoint in a Phase 3 trial in December 2025, with an FDA submission planned for the second quarter of 2026. Immunome expects three additional investigational new drug applications and early data from IM-1021 across 2026. The company's stock has risen 250% over the past year, bringing its market capitalisation to $2.40 billion.

Yahoo Finance
Mar 6th, 2026
Immunome cuts 2025 net loss to $212M, files $156M shelf registration ahead of varegacestat NDA

Immunome has reported a reduced full-year net loss of $212.39 million for 2025 and filed a $156.03 million common stock shelf registration linked to an employee stock option plan offering. The biotechnology company also updated investors on progress in its oncology pipeline. The company plans to file a New Drug Application for varegacestat following positive Phase 3 data, with multiple solid tumour investigational new drug applications also in development. However, Immunome remains deeply unprofitable despite the narrower losses. The shelf registration raises concerns about potential equity dilution and ownership overhang. Fair value estimates from analysts vary widely, ranging from approximately $29 to over $215 per share, reflecting significant uncertainty around the company's prospects as it advances its high-risk oncology platform.