Associate Director, Formulation Development

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🏄 California, New York, +1 états de plus – Distant

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

💵 $170 000 - $210 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 4%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Immuneering Corporation

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2008

🏥 Santé

💼 Conseil

🎖️ Défense

🔥 Financement dans la dernière année

💰 €200 000 005 Post-IPO Equity - Immuneering en 2025-09

Healthcare • Consulting • Defense

Immuneering Corporation est une entreprise de biotechnologie au stade clinique, développant une nouvelle classe de thérapies en oncologie appelée Inhibiteurs Cycliques Profonds, qui utilisent un dosage rythmique pour dépasser l'adaptation du cancer, améliorer la tolérabilité et prolonger la survie et la qualité de vie des patients. La société fait progresser un pipeline à travers des essais cliniques, collabore avec des partenaires et met l'accent sur la recherche scientifique et les publications pour transformer le traitement du cancer tout en réduisant les effets secondaires des thérapies d'inhibition continue traditionnelles.

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

🎯 Exigences

• 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

🏖️ Avantages

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

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