Associate Director, Formulation Development

Job not on LinkedIn

🕒 September 22

🏄 California, New York, +1 more states – Remote

🏄 California – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote

💵 $170k - $210k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Immuneering Corporation

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🎖️ Defense

💰 $200M Post-IPO Equity - Immuneering on 2025-09

Healthcare • Consulting • Defense

Immuneering Corporation is a clinical-stage biotechnology company developing a novel class of oncology therapies called Deep Cyclic Inhibitors, which use rhythmic dosing to outpace cancer adaptation, improve tolerability, and extend patient survival and quality of life. The company advances a pipeline through clinical trials, collaborates with partners, and emphasizes scientific research and publications to transform cancer treatment while reducing side effects of traditional continuous-inhibition therapies.

📋 Description

• 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

• 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

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