Associate Director, Formulation Development

Immuneering Corporation

. Oversee all aspects of the drug product development program from candidate nomination through clinical development .

Posted 9/22/2026full-timeRemote • United StatesSenior💰 $170,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drug product development, including formulation design, process development, and regulatory submissions. Proficient in managing CDMOs and ensuring compliance with FDA, EMA, and ICH guidelines.

Highest-signal resume keywords

PhD In Pharmaceutics Or Related DisciplineDrug Product Technology TransferFormulation Development For BCS Class II/IV CompoundsRegulatory Submissions And ResponsesExperience Managing CDMOs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pre-Formulation StudiesFormulation Design And DevelopmentDrug Product Manufacturing Process DevelopmentQuality InvestigationsRisk AssessmentQbDQTPPCQACMACPP

Soft Skills

Exceptional Decision-Making SkillsValues-Based LeadershipCommitment To Integrity And Ethics

Tools & Technologies

HPLCLC-MSXRPDDSCDissolutionKF

Industry Keywords

CGMPFDA GuidelinesEMA GuidelinesICH GuidelinesPediatric Formulation Development

About the role

Key responsibilities & impact

Oversee all aspects of the drug product development program from candidate nomination through clinical development
Conduct pre-formulation studies, including API form characterization and selection, 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 and cost-effective drug product manufacturing processes
Direct drug product process development, technology transfer and manufacturing campaigns at external CDMOs
Review and approve process development protocols, master batch records, manufacturing campaign reports, executed batch records, quality investigations and batch disposition records
Provide person-in-plant support for manufacturing campaigns as required
Assist in establishing critical quality attributes and critical process parameters
Author or review development reports and risk assessments
Author assigned CMC sections for IND, IMPD, NDA and MAA filings and respond to regulatory agencies
Serve as drug product subject matter expert for cross-functional teams
Collaborate across CMC and the wider development team to deliver quality drug product for clinical trials
Maintain technical expertise in formulation and process development
Work in compliance with cGMP, safety and regulatory requirements
Report to the Head of CMC

Requirements

What you’ll need

PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 8+ years of industry experience; or MS or BS degree in a related discipline with 12+ years of industry experience
Foundational understanding of pre-formulation studies, formulation design and development, and drug product manufacturing process development
Experience developing formulations for 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 FDA, EMA, and ICH regulatory guidelines
Ability to apply regulatory guidance to practical solutions and development strategies
Exceptional decision-making skills and ability to work independently in a fast-paced, high-pressure setting
Excellent technical writing skills, including regulatory submissions and responses to regulatory questions
Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture
Preferred: background in dry/wet granulation, extrusion, spray drying, tableting and coating
Preferred: understanding of physicochemical and biopharmaceutical properties related to formulation design
Preferred: QbD, QTPP, CQA, CMA, CPP, FMEA and risk assessment experience
Preferred: pediatric formulation development
Preferred: HPLC, LC-MS, XRPD, DSC, dissolution and KF
Preferred: IND/IMPD and NDA/MAA submissions
Preferred: managing quality investigations

Benefits

Comp & perks

Remote work
Travel: 10 to 20%
Inclusive and collaborative, mission-driven culture
Equal opportunity employment