Director / Senior Director - External Manufacturing Operations
About the job
- A bachelor's degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or a related field is required; an advanced degree is preferred.
- At least 15 years of progressive biotechnology or pharmaceutical industry experience, including significant responsibility for cGMP manufacturing operations and oversight of external manufacturing partners.
- Demonstrated experience leading external manufacturing activities supporting clinical and commercial products.
- Ability to build and manage strategic relationships with CDMOs, including engagement with senior business leaders, site heads, and executive management.
- Experience contributing to manufacturing network strategy, supply planning, technology transfer, commercial readiness, and risk management.
- Strong leadership and people-management skills, including coaching, developing, and retaining high-performing professionals.
- Success managing complex external manufacturing organizations and supplier relationships across development and commercial stages.
- Strategic thinking and business judgment to balance technical, operational, financial, quality, regulatory, and supply considerations; ability to identify and manage manufacturing and supply risks, resolve complex issues, and drive cross-functional decision-making.
- Broad technical understanding of biotechnology and pharmaceutical manufacturing and process development.
- Strong understanding of cGMP requirements and pharmaceutical Quality Systems, including deviations, investigations, change controls, CAPAs, and batch disposition activities.
- Strong executive communication, influencing, and negotiation skills, including the ability to engage internal and external senior leadership effectively.
- Expert knowledge of supply agreements, service agreements, statements of work, and other commercial terms relevant to external manufacturing.
- Ability to work effectively in a fast-paced and evolving environment, manage ambiguity, and adjust priorities while maintaining focus on critical business objectives.
- Ability to travel domestically and internationally up to approximately 25%, with occasional evening and/or weekend commitments based on manufacturing activities and business needs.
- Provide overall leadership for the External Manufacturing Operations function, with responsibility for the performance, development, and effectiveness of the team overseeing CDMOs and other external service providers.
- Lead, coach, and develop a team of external manufacturing professionals; establish clear priorities, expectations, and accountabilities; support staff development and the growth of organizational capabilities as the portfolio and manufacturing network expand.
- Ensure Virtual Management Teams (VMTs) are empowered and operate effectively, collaboratively, and consistently across programs; lead resolution of significant risks, delays, and competing priorities that could affect supply or key program milestones.
- Establish and maintain effective governance across the external manufacturing network; ensure business reviews, steering committees, and executive-level meetings occur at appropriate frequencies and with appropriate engagement; serve as a senior escalation point for significant operational, contractual, supply, and relationship matters.
- Build cross-functional relationships and partner with Technical Operations leadership, Legal, Finance, Regulatory, and other stakeholders to align activities and meet business objectives.
- Provide senior leadership with timely updates on manufacturing performance, supply risks, network capacity, financial considerations, and other matters requiring management attention or decision-making.
- Contribute to the development and execution of the external manufacturing and supply network strategy and business continuity planning.
- Support regulatory submission activities and regulatory inspections as required.
- Contribute to continuous improvement of Technical Operations processes, governance frameworks, and ways of working to support growth of the product portfolio and external manufacturing network.
- Hands-on experience in process development and/or cGMP manufacturing is strongly preferred.
- Experience with highly potent products is desirable.
About the company
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
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Simplify's Take
What believers are saying
- $520 million cash on June 30, 2026 funds operations into 2028.
- Phase 3 RINGSIDE cut desmoid progression risk 84%, strengthening varegacestat launch odds.
- First-patient dosing in IM-1617 June 2026 and IM-3050 July 2026 widens shots on goal.
What critics are saying
- The $156 million shelf and repeated offerings signal ongoing dilution pressure into 2027.
- IM-1617 and IM-3050 remain early, so a single failure weakens the platform narrative.
- If varegacestat misses April 28, 2027 approval, Immunome loses its near-term commercial anchor.
What makes Immunome unique
- Varegacestat NDA accepted July 2026; April 28, 2027 PDUFA validates Immunome’s clinical execution.
- IM-1617, IM-1021, and IM-3050 reuse HC74, building platform learning across modalities.
- Undisclosed RTK and FAP targets protect differentiation while competitors chase known antigens.
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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
6 month growth
25%1 year growth
25%2 year growth
25%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.
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/
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.
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.
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.