Senior Formulation Development Lead, Drug Product

Immuneering Corporation; Cambridge (MA); Hybrid; 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, formulation screening, and scalable manufacturing process development for drug products. You will collaborate with Process Chemistry, manage CDMOs, and contribute to regulatory filings.

The role requires a PhD or equivalent with 8+ years (or MS/BS with 12+ years) in pharmaceutics or related field, strong technical writing, and a track record in cross-functional leadership

Qualifications

• PhD with 8+ years of industry experience or MS/BS with 12+ years.
• Foundational understanding of pre-formulation and product development.
• Experience with poorly soluble compounds and advanced formulation strategies.
• Experience managing CDMOs and technology transfer.
• Familiarity with FDA/EMA/ICH guidelines and regulatory submissions.
• Strong written communication and independent problem-solving.

Responsibilities

• Lead pre-formulation studies and formulation screening in collaboration with Process Chemistry.
• Define phase-appropriate formulation approaches balancing clinical needs and regulatory expectations.
• Develop scalable, cost-effective drug product manufacturing processes.
• Coordinate external CDMOs for development and manufacturing campaigns.
• Author development reports, risk assessments, and regulatory submission sections.
• Ensure compliance with cGMP, safety and quality standards.
• Provide expert guidance to cross-functional project teams.

Skills

Regulatory strategy

Technical writing

Independent work

Decision making

Cross-functional collaboration

Problem solving

Leadership

Education

PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline

MS or BS degree in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline

Tools

HPLC

LC-MS

XRPD

DSC

Dissolution

KF

Job description

Immuneering Corporation in Cambridge, MA is seeking an Associate Director of Formulation Development to lead pre-formulation, formulation screening, and scalable manufacturing process development for drug products. You will collaborate with Process Chemistry, manage CDMOs, and contribute to regulatory filings.

The role requires a PhD or equivalent with 8+ years (or MS/BS with 12+ years) in pharmaceutics or related field, strong technical writing, and a track record in cross-functional leadership