Associate Director, Biologics Formulation Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the formulation development strategy for a new bispecific fusion protein from the preclinical stage through to clinical development.

• Design and implement studies to evaluate protein stability, aggregation, degradation pathways, viscosity, and developability under relevant formulation conditions.

• Create liquid formulations and, when appropriate, lyophilized formulations to support both IV and SC presentations.

• Oversee excipient screening, buffer optimization, pH adjustment, surfactant selection, and stress stability studies to identify robust drug product formulations.

• Spearhead high-concentration formulation development for subcutaneous delivery, including assessments for syringeability, injectability, and device compatibility.

• Collaborate closely with Analytical Development to establish suitable characterization methods for formulation screening, stability assessments, and comparability studies.

• Work in partnership with Drug Substance, Process Development, Quality, Regulatory, Clinical Supply, and external CDMOs to ensure coherence between formulation strategy, manufacturability, and clinical requirements.

• Provide technical leadership in drug product process development, fill-finish considerations, container closure selection, and technology transfer activities.

• Act as the formulation subject matter expert during regulatory interactions and contribute to CMC sections of regulatory filings, including IND, IMPD, and BLA submissions.

• Identify formulation-related risks early on and create mitigation strategies to support program timelines and ensure long-term product quality.

• Assess and implement new technologies and platform approaches to enhance formulation development capabilities for complex biologics.

⛳️ Requirements

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related field with 8+ years of relevant industry experience; or M.S. with 10+ years of relevant experience.

• Extensive expertise in formulation development for biologics, including monoclonal antibodies, bispecific antibodies, fusion proteins, or other large-molecule therapeutics.

• Strong hands-on experience in protein stability assessment, excipient selection, buffer optimization, and formulation screening for both early- and late-stage development.

• Proven experience in developing formulations for high-concentration biologics, as well as supporting subcutaneous and intravenous presentations.

• Knowledge of key challenges associated with complex protein therapeutics, including aggregation, fragmentation, oxidation, deamidation, viscosity, and interfacial instability.

• Experience collaborating with external CDMOs and managing outsourced formulation and drug product development activities.

• Solid understanding of drug product manufacturing, fill-finish operations, container closure systems, and clinical supply requirements.

• Familiarity with regulatory expectations for formulation and drug product development within biologics programs.

• Excellent leadership, communication, and project management skills, with the ability to work effectively across multidisciplinary teams.

• Prior experience supporting regulatory submissions and health authority interactions is preferred.

🏝️ Benefits

• Flexible working arrangements

• Professional development opportunities