Associate Director, Formulation Development

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Cambridge, MA, US

12 days ago Requisition

$ To $ Annually

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.

• 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

• 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

• Strong theoretical and practical background in relevant pharmaceutical technologies such as dry/wet…