We are seeking a Formulation Research Scientist to support the advancement of drug candidates from early development through commercial line extension. This role operates within a Quality by Design (QbD) framework, leveraging both laboratory and computational tools to design dosage forms and optimize manufacturing processes.
The ideal candidate will have a strong foundation in pharmaceutical sciences, chemistry, or engineering, with hands-on experience in formulation development, process scale-up, and regulatory documentation. This position offers the opportunity to contribute to high-impact programs across clinical and commercial stages.
Key Responsibilities
- Design and develop dosage forms for clinical and commercial use
- Formulate stable and bioavailable drug products across various formats (e.g., solutions, suspensions, amorphous systems, solid oral dosage forms, parenterals)
- Plan, execute, and analyze experiments; present findings to cross-functional teams
- Generate data for regulatory filings and support optimization and scale-up studies
- Maintain detailed laboratory notebooks documenting protocols, results, and observations
- Interpret experimental data and troubleshoot formulation challenges
- Perform basic statistical analysis to support formulation decisions
- Document experimental outcomes in presentations and technical reports
- Transfer technical knowledge to CROs for clinical preparations
- Oversee outsourcing activities including scale-up and tech transfer to CMOs
- Collaborate with internal teams (Analytical Development, Materials Characterization, Supply Chain, QA) to ensure timely production of clinical trial materials
- Contribute to regulatory documentation and filing preparation
- Adhere to all relevant safety and GMP procedures
Requirements
Qualifications
- PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field with 0–3 years of experience or
- Master’s degree with 3+ years of experience or
- Bachelor’s degree with 6+ years of experience
- Strong conceptual knowledge of pharmaceutical and engineering principles for solid dosage form development
- Hands-on experience with formulation techniques, processing equipment, and unit operations at lab and clinical scales
- Proficiency in material/energy balances and applied statistical analysis
- Strong technical writing and data interpretation skills
- Excellent verbal and written communication abilities
- Solid background in physical chemistry and material properties
- Familiarity with QbD principles and regulatory filing processes is a plus
- Experience with small molecule NCEs and early-phase formulation development
- Exposure to a range of dosage forms including liquids, solids, and oral formulations
- Proven ability to manage scale-up and manufacturing of solid oral dosage forms
- Ability to apply scientific principles to formulation development using a rational, data-driven approach
- Comfortable working in multidisciplinary teams under defined timelines
- Strong organizational and teamwork skills
- Experience with GLP, GMP, and GxP environments
Benefits
- Contract position with possible extension