Scientist II, Formulation Development

Job Description Summary

The Scientist II, Formulation Development actively contributes to drug discovery and drug product development by designing, manufacturing, and characterizing phase‑appropriate formulations and processes, ensuring a timely supply of formulations or drug product for discovery, preclinical, and clinical studies. The role involves laboratory activities, data analysis, study planning, and communication of results to cross‑functional team members, line management, and stakeholders.

• Designs and develops robust formulations and manufacturing processes for small molecule compounds from drug discovery and/or development programs for preclinical and clinical studies.
• Prepares experimental designs, evaluates data, coordinates and executes pre‑formulation, formulation, and process development studies, identifies pharmaceutical development challenges, and recommends potential solutions.
• Conducts pre‑formulation and formulation studies using techniques such as TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, and pH measurement.
• Works with internal and external partners as necessary to meet formulation needs.
• Develops safe, viable, and robust formulations using pharmaceutically acceptable inactive ingredients that enable the delivery of water‑insoluble compounds by multiple routes of administration.
• Conducts formulation and process technology transfers to external partner sites and monitors activities at CDMOs to meet project timelines.
• Designs studies and conducts phase‑appropriate risk assessments as per target product profiles to build in quality‑by‑design (QbD) during formulation and process development.
• Conducts formulation and process scale‑up and optimization studies using QbD tools including design of experiments (DoE) and other modeling and scale‑up tools.
• Provides pre‑formulation, formulation, and manufacturing support for drug product formulation development; and for the transfer of formulation development to contract manufacturing organizations, as necessary.
• Independently oversees the maintenance and calibration of laboratory instrumentation within the group (TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH).
• Maintains safe laboratory working conditions and a steady uninterrupted supply of raw materials, reagents, supplies, and any required tools.
• Summarizes experimental work in reports and presents study plans and results to broader teams in a timely manner.
• Authors the drug product sections of regulatory submissions such as INDs, CTAs, NDAs, and MAAs as necessary.
• Maintains appropriate experimental records in laboratory notebooks.
• Mentors and coaches junior team members.
• Performs other tasks and assignments as needed and specified by management.

Minimum level of education and years of relevant work experience:

• PhD degree in pharmaceutical science, material science, chemistry or related discipline with a minimum of 2 years of relevant experience;
• Master’s degree in the same disciplines with a minimum of 4 years of relevant experience;
• Bachelor’s degree in the same disciplines with a minimum of 6 years of relevant experience in discovery formulation, pre‑formulation or formulation development in a pharmaceutical, biotechnology, or related environment.

Special knowledge or skills needed and/or licenses or certificates required:

• Hands‑on experience and demonstrated proficiency with basic laboratory skills, design, development, and characterization of liquid and solid dosage forms using formulation equipment such as blenders, granulators, roller compactors, tablet presses, coaters, and fluid‑bed dryers.
• Proven understanding of physical pharmacy and engineering concepts in formulation and process development and related scale‑up principles.
• Proficiency in working with and overseeing CMOs for formulation development and manufacture for PTC.