Position Overview

Immunome is seeking a highly experienced and collaborative Senior Manager, Analytical Development and QC, Small Molecule to lead analytical method development, validation, and quality control activities supporting our small molecule programs from early development through regulatory submissions and commercialization.

The successful candidate will bring deep technical expertise in small molecule analytical chemistry, understanding of cGMP and ICH expectations, and proven experience operating in an outsourced development model with CDMOs and contract testing laboratories. Reporting to the Director, Analytical Development & QC, this individual will shape Immunome’s small molecule analytical development and QC strategy and advance our oncology pipeline.

Responsibilities

Strategic Leadership

• Develop and execute phase-appropriate analytical development and QC strategies for ADC linker payload components, small molecule intermediates, and drug substance, including specifications and control strategies.
• Provide technical leadership for analytical method development, qualification, validation, and lifecycle management.
• Establish and maintain analytical development plans, stability strategies, and comparability/bridging approaches to support process changes, scale-up, and technology transfers.

Program Oversight and Execution

• Manage execution of analytical testing to support in-process controls, release, stability, and characterization.
• Partner with cross-functional leaders across CMC, Process Chemistry, Manufacturing, QA, and Regulatory to ensure seamless integration of analytical deliverables within development timelines.
• Critically review and interpret analytical data to troubleshoot methods, manufacturing issues, investigate OOS/OOT results, and drive root-cause analysis and CAPA activities.
• Support review of batch records from an analytical perspective.

Vendor and Partner Management

• Manage and provide technical oversight of CDMOs, and contract testing labs to ensure high-quality, timely, and compliant method development, validation, and routine QC testing.
• Lead scope definition, issue resolution, deviations, change controls, and inspection readiness activities.

Regulatory and Documentation Support

• Author and review analytical sections of CMC documents and regulatory submissions (e.g., IND/CTA, NDA/MAA, CTD), including method descriptions, validation summaries, specifications, and stability data.
• Support responses to analytical and quality-related questions from global health authorities and internal stakeholders.
• Ensure all analytical activities comply with cGMP and relevant regulatory/compendial guidance (e.g., ICH Q2, Q3, Q6A, Q7; USP/EP/JP).

Leadership and Collaboration

• Communicate complex analytical concepts, results, and recommendations clearly and effectively to diverse audiences.
• Contribute to building Immunome’s internal analytical capabilities and best practices, including evaluation of new technologies and analytical approaches where appropriate.

Qualifications

• A minimum of a Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field with 5+ years of industry experience; or an M.S. with 10+ years; or a B.S. with 12+ years. Experience must be in small molecule analytical development and QC within the biopharmaceutical industry.
• Demonstrated experience developing, validating, and transferring analytical methods, small molecule intermediates and drug substance in cGMP environment.
• Hands-on expertise with chromatography and related techniques (HPLC/UPLC, GC, LC-MS, Karl Fischer, spectroscopy) and impurity profiling.
• Experience managing external partners (CDMOs/contract testing laboratories) and stability programs.
• Prior oncology drug development experience preferred.
• ADC linker payload experience preferred.
• Up to 25% travel.

Knowledge and Skills

• Highly skilled in method development using chromatographic and supporting techniques (LC, GC, IC)
• Solid understanding of phase-appropriate control strategies for small molecules (specifications, impurities, stability, and comparability).
• Working knowledge of cGMP expectations and analytical-related ICH/compendial guidance (e.g., ICH Q2, Q3, Q6A, Q7; USP/EP/JP).
• Excellent communication skills — capable of clearly conveying complex data, technical concepts, and recommendations to diverse audiences.
• Exceptional organizational, analytical, and problem-solving skills.
• Ability to work effectively in a fast-paced, dynamic biotech environment and balance multiple priorities.

Position Overview 

The Senior Manager / Associate Director, External Manufacturing Operations is responsible for meeting Immunome’s supply requirements by enabling and overseeing operations performed at Contract Development and Manufacturing Organizations (CDMOs). This role focuses on biologics manufacturing but will support additional modalities as needed. 

Responsibilities 

• Serve as the Supplier Relationship Manager (SRM) for specified CDMOs and primary liaison between the CDMO and Immunome.   

• Collaborate closely with Legal to support the development and negotiation of service agreements, supply contracts, and statements of work across development and commercial phases.   

• Lead one or more Virtual Management Teams (VMTs) comprising Quality, Product Supply, Technical Development, and other cross-functional stakeholders as necessary. Ensure Immunome’s project deliverables stay on track. Align priorities and key communications with the CDMO.    

• Conduct well-organized and documented project team meetings with CDMOs. Ensure CDMO progress is tracking to plan (e.g., campaign preparation, manufacturing operations, release activities, logistics, etc.). Proactively address delays to avoid impact on supply or regulatory milestones.     

• Develop a thorough understanding of Immunome’s drug product manufacturing processes. Support technical reviews of master and executed batch records, specifications, investigations, and change requests, as required.  

• Monitor CDMO performance through Key Performance Indicators (KPIs) and drive improvements aligned with Immunome’s expectations. Lead or participate in periodic Business Review Meetings.   

• Work closely with department management and finance team to provide timely progress updates. Ensure that unexpected cost variances are communicated quickly.     

• Maintain comprehensive knowledge of the CDMO’s systems, capabilities, capacities, requirements, and business practices.   

• Monitor spending against budget. Ensure CDMO invoicing is accurate and aligned with contractual terms.   

Other Responsibilities and Projects

• Assist with technology transfers as needed, change implementation, and regulatory submission reviews.   

• Support Technical Operations sourcing efforts and the qualification of new CDMOs.    

• Support risk assessment development, and implementation of manufacturing network strategies.  

• This is an individual contributor role. Depending on the business needs and organizational considerations, this role may include staff supervisory responsibly as the product portfolio and manufacturing network expand.    

Qualifications 

• Bachelor’s or advanced degree in biotechnology, biology, chemistry, chemical engineering, or related field.  

• Minimum of 10 years of biopharmaceutical industry experience, and direct responsibility overseeing third parties performing cGMP manufacturing.     

• Ability to travel (domestic and international) up to 25%, with occasional evening and/or weekend commitment.   

Knowledge and Skills 

• Strong organizational, communication, and collaboration skills.  

• Strong technical background in biotechnology/pharmaceutical manufacturing or process development.    

• Hands-on expertise in drug product process development or cGMP drug product manufacturing. Experience with highly potent products is desired.   

• Prior success in overseeing external manufacturing operations is required, either as an SRM or Subject Matter Expert (SME). Experience with both clinical and commercial manufacturing is desired.  

• Well-versed in Quality systems and experienced with deviation investigations, change controls, and corrective actions.  

• Possess strong negotiation skills and be versed in general contractual terms.   

• Comfortable with ambiguity and uncertainty; adapt swiftly with focus on delivering to the business needs as priorities change.   

Position Overview

The Director, Supply Operations will lead and develop Immunome’s Supply Operations function.  This role is accountable for ensuring efficient, compliant, and uninterrupted supply of clinical and commercial packaged products.  This is a highly visible role that will help shape Product Supply infrastructure, external partner networks, operational and business processes critical to Immunome’s growing pipeline and commercial success. 

Responsibilities

• Develop and oversee a high-performing team of supply operations professionals. Maintain a positive and inclusive environment where staff are motivated, empowered, and challenged.        

• Accountable for the successful planning and execution of clinical and commercial labeling and packaging operations.   

• Own business relationship with relevant external suppliers. Develop and implement metrics and KPIs to measure performance. Ensure supplier performance is routinely reviewed via formal business review meetings and periodic executive steering committee meetings.   

• Actively engage with Planning, Commercial, Clinical Development, and Regulatory to understand evolving commercial supply and clinical study plans.   

• Monitor drug inventory levels across distribution depots and trial sites, working closely with the Planning team to ensure supply plans are appropriately adjusted as needed.   

• Advise cross-functional teams on optimal supply strategy, associated timelines, and risks.  Ensure plans are communicated and integrated into program timelines.  

• Design, develop, and implement business processes and cGMP procedures encompassing but not limited to labeling and packaging operations, comparator and co-medication sourcing, returns and reconciliation.  

• Support department leadership and Finance team to develop budgets and performance targets, ensure spending is accurately tracked and variances are communicated proactively.  

• Support the development and implementation of supply management tools for use in day-to-day operations. Support the design and implementation of systems including ERP, Serialization, IRT, etc.  

• With a continuous-improvement mindset, seek opportunities to evolve processes and systems to increase compliance and efficiency.    

• Partner with Quality to ensure efficient documentation reviews pre- and post-production and support QP release requirements where required.   

• Manage Quality systems work, including training, change controls, investigations, corrective and preventive actions.   

Qualifications

• Bachelor’s or advanced degree in Supply Chain Management, Biotechnology, or related field.  

• APICS or ISM certification is preferred.    

• Minimum of 12 years of biopharmaceutical industry experience in supply chain roles, supporting both clinical and commercial product supply.  

• Minimum of 8 years of supervisory experience.  

• Position will require domestic and international travel (up to 20%) and occasional evening and/or weekend commitment.  

Knowledge and Skills

• Excellent cross-functional collaboration, communication, and influencing skills.  

• Strong business acumen, including budgeting, forecasting, and contract negotiation.  

• Demonstrated ability to lead through ambiguity and scale operations in a dynamic environment.  

• Experience with both sterile injectables and oral dosage forms is desired.  

• Strong understanding of clinical and commercial supply and distribution models and frameworks.    

• Demonstrated experience supporting commercial product launches.  

• Thorough understanding of regulations applying to supply chain activities, including cGMP, GCP, GDP, and computer systems/Part11 compliance.     

• Thorough understanding of clinical and commercial labeling and packaging requirements, planning, and execution.   

Position Overview

We are seeking an experienced and motivated Principal Purification Process Development  Scientist to support our growing ADC pipeline. This role will be responsible for the optimization of purification processes for antibody intermediates (mAbs). The preferred candidate will coordinate and/or execute purification strategies including scale-up to tox/GMP, while demonstrating expertise in practical, robust purification strategies applicable to clinical and commercial-stage manufacturing of mAbs. The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities. A strong working knowledge of different purification technologies is essential, as is experience with standard analytical and characterization approaches used for biologics.

Responsibilities

• Oversee Purification Process Development strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical process parameters.
• Fulfill the role of a purification subject matter expert (SME) on cross-functional CMC teams to ensure alignment on program goals, deliverables, and objectives.
• Collaborate with external CDMO partners to support the Immunome pipeline from pre-clinical, through clinical and commercial stages. Occasional travel to advise and oversee development and GMP manufacturing processes will be expected.
• Prepare essential documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.
• Stay current with emerging trends, innovations, and regulatory requirements for mAb purification processes, integrating necessary or potentially beneficial features into our internal company strategies and workflows.

Qualifications

• A Bachelor’s, Master’s, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
• A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 with Masters or 10 with Bachelors with a primary focus on purification process development.
• Prior experience with tech transfer, external CDMO engagement, and internal coordination with relevant functions.
• Prior knowledge of/experience working with GMP manufacturers and processes, including familiarity with regulatory submissions.
• Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc).
• Familiar with laboratory operations and needs for establishing a highly functioning development lab.
• Demonstrated success in developing and optimizing purification processes for monoclonal antibodies and recombinant proteins.
• Experience in regulatory submissions, responding to information requests, and interfacing with health authorities.

Knowledge and Skills

• A strong understanding of the common purification, analytical, and characterization approaches used for mAbs, with a solid foundation in overcoming some of the challenges encountered in these workflows.
• Must be a purification subject matter expert including chromatography separations and filtration operations (depth, dead-end, virus and ultrafiltration/diafiltration).
• Expert user of AKTA chromatographic instruments (such as AKTA Avant, AKTA Ready or similar).
• Design, plan, schedule, organize, prioritize, execute, document and present complex experiments using Design of Experiment (DOE) when needed.
• The ability to manage multiple projects simultaneously while being able to prioritize and balance hands-on tasks with strategic responsibilities.
• Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners.
• High-throughput liquid handling systems (Tecan) experience is a plus.