Associate Director, Formulation Development

The Associate Director, Formulation Development will be responsible for overseeing all aspects of Immuneering's drug product development program, from candidate nomination through the clinical development stage of product lifecycle. This entails the conduct of pre-formulation studies, formulation development, tech transfer, scale-up and manufacturing. This position requires experience in solid oral dosage formulation development, including enabling formulations for poorly soluble (BCS Class II/IV) compounds, and API form characterization and selection. This position also requires a thorough understanding of the principles of quality by design (QbD), and extensive experience in scientific technical writing for drug development and regulatory submissions. Prior experience managing drug product process development and manufacture at CROs and CDMOs is also critical for this position. The successful candidate will be a highly motivated, proactive team player with a strong background in formulation science and process development, and a proven track record of accomplishments. This position will report to the Head of CMC. Job Functions and Responsibilities 022; Conduct pre-formulation studies, including API form characterization and selection, in collaboration with Process Chemistry 022; Design, execute, and interpret formulation screening and excipient selection studies 022; Define phase-appropriate formulation approaches that balance clinical needs, manufacturability, regulatory expectations, and commercial considerations 022; Develop innovative, robust, efficient, scalable and cost-effective drug product manufacturing processes 022; Act as the main point of contact directing drug product manufacturing process development, technology transfer and manufacturing campaigns at external CDMOs, including development, review and approval of process development protocols, master batch records and manufacturing campaign reports 022; Provide person-in-plant support for drug product manufacturing campaigns as required 022; Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records 022; Assist in establishing critical quality attributes and critical process parameters for drug products in development 022; Author or review development reports and risk assessments 022; Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies 022; Serve as drug product SME for cross-functional project teams 022; Collaborate within CMC and across the wider development team to deliver quality drug product for clinical trials within required timelines 022; Serve as a technical expert and keep current in the field of formulation and process development 022; Work in compliance with cGMP, safety and regulatory requirements 022; Champion a strong winning culture through the relentless pursuit of excellence, fostering a collaborative and collegial approach to teamwork, and a first-in-class quality organization Education, Skills and Qualifications Required: 022; PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 8+ years of industry experience; or MS or BS degree in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 12+ years of industry experience 022; A foundational understanding of pre-formulation studies, formulation design and development and drug product manufacturing process development 022; Experience in formulation development of poorly soluble (BCS Class II/IV) compounds (e.g., amorphous solid dispersions (spray-dried dispersions, hot-melt extrusions), lipid-based and self-emulsifying formulations (SEDDS, SMEDDS, lipid suspensions, LNPs, SLNs), micro-encapsulation, micro/nano formulations (nanocrystals, nanosuspensions), salt formulations, co-crystals, etc.) 022; Experience in drug product technology transfer and manufacture 022; Experience managing CDMOs for research, development and manufacturing campaigns 022; Solid understanding of relevant FDA, EMA, and ICH regulatory guidelines as applicable to drug product manufacturing, and current standards of practice in the industry 022; Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies 022; A critical and strategic thinker with exceptional decision-making skills and the ability to work independently in a fast-paced, high-pressure setting 022; Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions 022; Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture Preferred 022; Strong theoretical and practical background in relevant pharmaceutical technologies such as dry/wet granulation, extrusion, spray drying, tableting and coating 022; Fundamental understanding of physicochemical and biopharmaceutical properties as related to formulation design 022; Application of QbD principles to the drug development process, including experience in developing quality target product profiles (QTPPs), defining critical quality attributes (CQAs) and critical material attributes (CMAs), and determining critical process parameters (CPPs) using failure mode and effects analysis (FMEA) and other risk assessment tools 022; Expertise in pediatric formulation development 022; Thorough understanding of analytical techniques used for API form characterization and selection and pre-formulation studies including HPLC, LC-MS, XRPD, DSC, Dissolution, and KF 022; Experience in IND/IMPD and NDA/MAA submissions 022; Experience in managing quality investigations 022; Self-motivated, detail-oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills 022; Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment Additional Information 022; Travel: 10 to 20% 022; Location: Remote