Formulation Development Lead — Associate Director (Remote)

Socket.dev; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Remote work

Travel 10–20%

Job summary

Immuneering Corporation is seeking an Associate Director of Formulation Development to lead pre-formulation and formulation strategies for solid oral dosage forms. You will oversee technology transfer, scale-up, and manufacturing campaigns, working with external CDMOs to ensure quality and regulatory compliance.

The role requires a PhD with 8+ years or a MS/BS with 12+ years in pharmaceutics or related fields, with strong technical writing, QbD, and regulatory submission experience.

Qualifications

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline 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 and related technologies.
• Experience in drug product tech transfer and manufacturing.
• Experience managing CDMOs for RD/validation/manufacturing campaigns.
• Knowledge of FDA/EMA/ICH guidelines applicable to drug product manufacturing.

Responsibilities

• Conduct pre-formulation studies including API form characterization and selection.
• Design, execute, and interpret formulation screening and excipient selection studies.
• Define phase-appropriate formulation approaches balancing clinical needs and regulatory expectations.
• Develop scalable, robust drug product manufacturing processes.
• Lead external CDMO collaborations and review PD protocols, master batch records, and campaign reports.
• Provide on-site support for drug product campaigns as needed.
• Review batch records and support quality investigations and dispositions.
• Contribute to CMC sections for IND/IMPD/NDA/MAA submissions.

Skills

Regulatory writing

Technical writing

Pre-formulation

CDMO collaboration

QbD knowledge

Education

PhD in pharmaceutics/related field

MS/BS in pharmaceutics/related field with 12+ years experience

Tools

HPLC

LC-MS

XRPD

DSC

Dissolution

KF

Job description

Immuneering Corporation is seeking an Associate Director of Formulation Development to lead pre-formulation and formulation strategies for solid oral dosage forms. You will oversee technology transfer, scale-up, and manufacturing campaigns, working with external CDMOs to ensure quality and regulatory compliance.

The role requires a PhD with 8+ years or a MS/BS with 12+ years in pharmaceutics or related fields, with strong technical writing, QbD, and regulatory submission experience.