Scientist II

Job Description

Job Summary:

• This Scientist II supports the development and optimization of drug delivery systems for combination products used in preclinical and clinical studies.
• Working as part of a multidisciplinary R&D team, this role conducts laboratory experiments, characterizes physicochemical properties of drug substances (including physical form, stability, solubility, and drug-excipient interactions), analyzes experimental data, and documents results.
• The scientist collaborates with senior team members to execute formulation development activities while building technical expertise in drug delivery, combination products, and pharmaceutical development.

Duties and Responsibilities:

• Apply established scientific methods and assist in evaluating technical approaches under the guidance of senior team members.
• Plan and execute laboratory experiments including analytical testing, including drug assay, degradants, and other physicochemical characterization using established methods; assist with method development, qualification, and validation activities as needed.
• Support release and stability testing activities by coordinating with internal and external laboratories and documenting results.
• Prepare technical documentation and data packages to support regulatory submissions, design history files, and other product development documentation.
• Participate on cross-functional product development teams, collaborating with formulation scientists, analytical scientists, manufacturing, quality, regulatory, and other functional groups to achieve project objectives.
• Identify opportunities for laboratory, experimental, or process improvements and contribute ideas that enhance efficiency, quality, and technical capability.
• Communicate technical findings clearly through written reports, presentations, and team discussions.
• Maintain laboratory activities and documentation in compliance with applicable quality system requirements, laboratory procedures, and safety practices.

Quality System Requirements:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required Qualifications:

• Bachelor’s degree or higher in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemistry, Materials Science, or related technical field.
• Minimum of 2 years of relevant experience with a Bachelor’s degree or 1 year of relevant experience with a Master’s degree in pharmaceutical, medical device, biotechnology, or a related product development environment.
• Understanding of pharmaceutics, physical chemistry, and drug delivery systems.
• Strong written and verbal communication skills, including the ability to prepare technical documentation and present scientific findings.

Preferred Qualifications:

• Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, or related technical field.
• Familiarity with analytical techniques such as HPLC, UPLC, GC, LC/MS, GC/MS, UV-Vis, DSC, TGA, or NMR.
• Understanding of analytical method development, qualification, or validation, especially for drug release, stability testing, or physicochemical characterization.
• Experience working within a regulated environment (FDA, ISO, GMP, or GLP) through academic or industry research.
• Knowledge of controlled drug delivery systems.
• Exposure to pharmacokinetic/pharmacodynamic (PK/PD) studies or preclinical model development is desirable.
• Strong organizational, analytical, and problem-solving skills with attention to detail.