Associate Director, Formulation Development — Oncology

Immuneering Corporation; Cambridge (MA); On-site; USD 170,000 - 210,000; Full time

Job summary

Immuneering Corporation in Cambridge, MA is seeking an Associate Director of Formulation Development to lead pre-formulation studies and develop scalable drug product manufacturing processes for oncology therapies. You will oversee technology transfer with CDMOs and ensure regulatory readiness for IND/IMPD/NDA submissions.

The role requires a PhD with 8+ years (or MS/BS with 12+ years) in pharmaceutics or related fields, deep knowledge of poorly soluble formulations, and strong regulatory

Qualifications

• PhD in pharmaceutics or related field with 8+ years of industry experience; or MS/BS with 12+ years of industry experience.
• Foundational understanding of pre-formulation, formulation design and development and drug product manufacturing process development.
• Experience in formulation development of poorly soluble (BCS II/IV) compounds including amorphous solid dispersions, lipid-based and self-emulsifying formulations, salt formations, co-crystals, etc.

Responsibilities

• Lead pre-formulation studies including API form characterization in collaboration with Process Chemistry.
• Design, execute, and interpret formulation screening and excipient selection studies.
• Define phase-appropriate formulation approaches balancing clinical needs, manufacturability, regulatory expectations, and commercial considerations.
• Develop robust, scalable, cost-effective drug product manufacturing processes.
• Direct drug product manufacturing process development and technology transfer at external CDMOs.

Skills

PhD in pharmaceutics

Drug formulation

Pre-formulation knowledge

CDMO management

Regulatory writing

Regulatory knowledge

Analytical skills

Education

PhD in pharmaceutics

MS/BS in pharmaceutics

Job description

Immuneering Corporation in Cambridge, MA is seeking an Associate Director of Formulation Development to lead pre-formulation studies and develop scalable drug product manufacturing processes for oncology therapies. You will oversee technology transfer with CDMOs and ensure regulatory readiness for IND/IMPD/NDA submissions.

The role requires a PhD with 8+ years (or MS/BS with 12+ years) in pharmaceutics or related fields, deep knowledge of poorly soluble formulations, and strong regulatory