Associate Director, Formulation Development

Job Description

Job Description

ABOUT IMMUNEERING

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.

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 

• Conduct pre-formulation studies, including API form characterization and selection, in collaboration with Process Chemistry 

• Design, execute, and interpret formulation screening and excipient selection studies 

• Define phase-appropriate formulation approaches that balance clinical needs, manufacturability, regulatory expectations, and commercial considerations 

• Develop innovative, robust, efficient, scalable and cost-effective drug product manufacturing processes 

• 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 

• Provide person-in-plant support for drug product manufacturing campaigns as required 

• Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records 

• Assist in establishing critical quality attributes and critical process parameters for drug products in development 

• Author or review development reports and risk assessments 

• Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies 

• Serve as drug product SME for cross-functional project teams 

• Collaborate within CMC and across the wider development team to deliver quality drug product for clinical trials within required timelines • Serve as a technical expert and keep current in the field of formulation and process development 

• Work in compliance with cGMP, safety and regulatory requirements 

• 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: 

• 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 

• A foundational understanding of pre-formulation studies, formulation design and development and drug product manufacturing process development 

• 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.) 

• Experience in drug product technology transfer and manufacture 

• Experience managing CDMOs for research, development and manufacturing campaigns 

• Solid understanding of relevant FDA, EMA, and ICH regulatory guidelines as applicable to drug product manufacturing, and current standards of practice in the industry 

• Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies 

• A critical and strategic thinker with exceptional decision-making skills and the ability to work independently in a fast-paced, high-pressure setting 

• 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 

Preferred 

• Strong theoretical and practical background in relevant pharmaceutical technologies such as dry/wet granulation, extrusion, spray drying, tableting and coating 

• Fundamental understanding of physicochemical and biopharmaceutical properties as related to formulation design 

• 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 • Expertise in pediatric formulation development 

• 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 

• Experience in IND/IMPD and NDA/MAA submissions 

• Experience in managing quality investigations 

• Self-motivated, detail-oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills 

• Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment 

Additional Information 

• Travel: 10 to 20% 

• Location: Remote 

EQUAL OPPORTUNITY EMPLOYER

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.