IMMUNEERING CORPORATION

Role Description The Associate Director, Process Chemistry will be responsible for overseeing all aspects of Immuneering’s small molecule drug substance manufacturing process development program, from candidate nomination through the clinical development stage of the product lifecycle. This position requires: - Experience in inventing novel, robust, efficient, and scalable synthetic routes that comply with all relevant regulatory requirements. - Implementation of these routes at scale for early to late-stage development. - A thorough understanding of the principles of quality by design (QbD). - Extensive experience in scientific technical writing for drug development and regulatory submissions. - Prior experience managing small molecule drug substance process development and manufacture at CROs and CDMOs. The successful candidate will be a highly motivated, proactive team player with a strong background in organic chemistry and a proven track record of accomplishments. This position will report to the Head of CMC and can be remote based in the US, with travel to Immuneering work locations for company meetings and other work partner sites as needed (up to approximately 20%). Qualifications - PhD in chemistry, chemical engineering or related sciences with 8+ years of industry experience; or MS or BS degree in chemistry, chemical engineering or related sciences with 12+ years of industry experience. - A foundational understanding of organic chemistry, solid form sciences, and process chemistry. - Strong understanding of synthetic organic chemistry reactions, techniques, and processes. - Experience in small molecule drug substance process development, technology transfer, and manufacture. - Application of QbD principles to the drug development process. - Experience managing CDMOs for research, development, and manufacturing campaigns. - Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to drug substance manufacturing. - Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies. - A critical and strategic thinker with exceptional decision-making skills. - Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions. - Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture. Requirements - Experience in IND/IMPD and NDA/MAA submissions is highly preferred. - Experience with drug substance process validation is highly preferred. - Experience in developing patent applications. - Experience in managing quality investigations. - Experience with modern analytical techniques and process analytical technologies (PAT). - Experience with modeling and simulation tools, and predictive analytics. - Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.). - Self-motivated, detail-oriented, with a continuous quality improvement mindset. - Excellent communication and problem-solving skills; thrives in a cross-functional team environment. Benefits - Travel: 10 to 20%. - Location: Remote. Company Description Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.

Role Description Be an integral part of Immuneering by spearheading, growing and developing robust quality processes and procedures. Join a diverse and collaborative group and make a deep impact of moving science forward in a fun, hybrid work environment which celebrates innovative thinking and where your input will be respected and sought out as an expert in your field. This role can be remotely based with the ability to travel to our offices and meetings as needed. The Director of Quality Systems & Compliance will be responsible for developing, implementing, and maintaining robust GxP-compliant quality systems to support Immuneering’s major initiatives related to our drug discovery, clinical trials, filings, and ultimately to commercialization. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player who embraces our mission, vision, and values. Specific Duties may include but not be limited to the following: - Serve as business owner for document and learning management systems which are maintained in an electronic quality management system (eQMS) for GxP activities. - Contribute to the development, implementation, and lifecycle management of GxP documents and training programs to ensure processes, systems, and content meet phase appropriate quality standards and business goals (e.g., Phase 3 requirements). - Author and maintain site policies, standard operating procedures (SOPs) for document control, training, quality events, Corrective and Preventive action (CAPA), change control, and risk management to support GxP compliance activities. - Ensure appropriate training requirements are defined in GxP job-specific roles and curriculum for company-wide matrix. Manage requirement updates, as applicable. - Administer learning management system via eQMS, curriculum creation, scheduling, reporting, and facilitate technical support guidance. - Ensure data integrity and compliance within all GxP electronic systems. - Partner with IT to ensure system upgrades, management, and business changes to eQMS are conducted in accordance with internal SOPs and external requirements. - Ensure compliance with legal and regulatory standards for document archival/retention. - Monitor and continuously improve system performance and inspection readiness, using metrics and analytics to proactively address risks, strengthen compliance, and enhance user experience. - Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness. - Participate in internal and external audits as needed. - Provide QA support for deviations, CAPAs, effectiveness checks, change controls, investigations (OOS/OOT), and risk assessments. - Lead investigation/CAPA triage meetings and collaborate with cross-functional groups to ensure timely resolution and metric compliance. - Support Quality Management Review Program by tracking and trending data for system performance and improvements. - Generate reports and dashboards to monitor GxP activity performance, compliance, and training effectiveness. - Act as a trusted advisor to internal teams, providing compliance guidance and facilitating timely resolution of quality issues. - Develop and maintain effective working relationships with stakeholder functions to achieve GxP compliance goals. - Exceptional attention to detail required. - Must be flexible and agile with the ability to pivot, to prioritize business needs. Qualifications - Minimum of a Bachelor’s degree in preferably life science (technology, biological science, pharmacy, nursing, or other health related discipline preferred) or equivalent qualification. - 8+ years’ experience in Quality and has supported pharmaceutical development from early phase transitioning into a commercial stage environment. - The ability to establish congenial and productive working relationships. - Exceptional communication skills, both written and verbal, QA writing skills are paramount. - Capability to manage multiple workflows within a single day. - Ability to effectively work within cross-disciplinary teams. - Must be a self-starter, proactive, motivated, ambitious, scientifically curious, and collaborative with a humble demeanor. Physical Demands/ Working Conditions - Requires prolonged sitting, some bending, stooping, and stretching. - Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. - Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. - No significant lifting is associated with the role. - While extensive travel is not anticipated with this role, it is possible to perhaps up to 10% at times. Company Description Immuneering (Nasdaq: IMRX) is a clinical-stage oncology company developing medicines for broad populations of cancer patients. Our initial aim is to develop a universal-RAS therapy, an approach designed to include patients with solid tumors driven by any mutation in KRAS, NRAS, or HRAS. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge, MA. Immuneering has grown to approximately 55+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Director of Project Management will oversee and drive the execution of global clinical trials in oncology. This leadership role is responsible for ensuring the successful planning, implementation, and completion of complex clinical programs, collaborating with cross-functional teams and external partners worldwide. - Lead the strategic planning and operational execution of global oncology clinical trials, ensuring projects are delivered on time, within scope, and budget. - Work with cross-functional project teams, including Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Data Management, and external vendors. - Develop and maintain detailed project plans, timelines, and risk management strategies for all assigned studies. - Monitor trial progress, proactively identify issues, and implement solutions to ensure quality and regulatory compliance. - Contribute to process improvement initiatives and best practices in global project management. - Work closely with other professional project managers who work in our early stage development programs. Qualifications - Bachelor’s degree in life sciences, healthcare, or related field; advanced degree (MS, PhD, MBA) preferred. - Minimum of 8 years’ experience managing global clinical trials in oncology, with demonstrated leadership in complex, multi-center studies and global regulatory submissions. - Proven track record in project management within the biopharmaceutical industry. - Strong understanding of regulatory requirements (FDA, EMA, ICH-GCP) for global clinical development. - Ability to travel domestically and internationally as required. Requirements - Exceptional communication, organizational, and leadership skills. - Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable). Physical Demands/ Working Conditions - Requires prolonged sitting, some bending, stooping, and stretching. - Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. - Requires the ability to perform essential job functions with or without reasonable accommodation. - No significant lifting is associated with the role. - While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. - Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Company Description Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description - Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis. - Author and review clinical protocols, ICFs, CSRs and regulatory documents. - Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies. - Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders. - Support investigator meetings, advisory boards and data monitoring committee meetings. - Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area. - Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs. - Work closely with CRO’s and have a can do, proactive biotech mindset. Qualifications - PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine). - Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry. - Direct Phase 3 oncology clinical trial experience required. - Demonstrate experience authoring and reviewing clinical documents. - Demonstrated strong experience in clinical trial execution and data interpretation. - Strong analytical, organizational, and communication skills. - Deep understanding of oncology clinical development, endpoints and regulatory expectations. Requirements - Excellent cross-functional communication and stakeholder management. - Ability to work collaboratively in a fast-paced, team-oriented environment. - Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable). Physical Demands/ Working Conditions - Requires prolonged sitting, some bending, stooping, and stretching. - Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. - Requires the ability to perform essential job functions with or without reasonable accommodation. - No significant lifting is associated with the role. - While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. - Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Company Description Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.