[Hiring] Associate Director, Formulation Development @IMMUNEERING CORPORATION

Role Description

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.

• 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
• 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

Qualifications

• 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
• 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
• 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

• 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
• Expertise in pediatric formulation development
• Thorough understanding of analytical techniques used for API form characterization and selection
• Experience in IND/IMPD and NDA/MAA submissions
• Experience in managing quality investigations
• Self-motivated, detail-oriented, with a continuous quality improvement mindset
• Excellent communication, problem-solving and organizational skills

Benefits

• Travel: 10 to 20%
• Location: Remote

Company Description

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.