Staff Scientist, Pharmaceutical Development

Responsibilities

• Develop early formulation strategies and serve as an SME to deliver fit-for-purpose formulations supporting PK, PD, efficacy, and safety preclinical studies through discovery to candidate selection across research programs.
• Design, manage, and execute early formulation screening studies to enable high-quality in vivo data, including solubility assessments, excipient compatibility, enabling approaches, and stability.
• Implement early formulation development and preparation workflows, tools, templates, and best practices internally and in partnership with CDMOs/CROs to support preclinical studies.
• Represent early formulation on cross-functional research teams, presenting data and recommendations to ensure aligned and timely support.
• Author and review technical documents to support early formulation activities and preclinical studies, including development reports and study protocols.
• Manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of formulations to support preclinical studies across programs.

Qualifications

• A PhD, MS, or BS in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field with a minimum of 6 years, 10 years, or 12 years, respectively, of relevant industry experience in small molecule formulation development.
• Demonstrated success delivering formulation strategies to support preclinical research studies using data-driven, risk-based strategies.
• Experience in small molecule formulation development across multiple routes of administration, including powders, solid dosage forms, solutions, suspensions, nanoparticles, and lipid-based systems.
• Hands-on experience with analytical techniques to support small molecule formulation development, including UPLC/HPLC and solid-state characterization techniques (e.g., particle size analysis, DSC, DVS, PLM, and XRPD).
• Working knowledge and practical application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
• Ability to manage and collaborate with external partners, including consultants and CDMOs/CROs.
• Excellent interpersonal and communication skills (written and oral) with the ability to effectively prepare high-quality technical documentation and concisely present data to peers, management, and external groups.
• Exhibited strong organizational and critical thinking skills with an attention to detail and data integrity enabling sound, technically driven decision making.
• Able to travel domestically and internationally as needed, up to 20% of the time.