Associate Scientist, Engineering II
BioSpace · North Chicago, IL · 1 mo ago
EngineeringFull-time
About the role
Independently generate reliable and reproducible data supporting development, characterization, and scale-up of oral solid dosage form manufacturing processes. Analyze and communicate technical results, support manufacturing campaigns and validation activities, and contribute to technical documentation supporting commercial readiness and regulatory submissions.
Responsibilities
- Perform routine laboratory and pilot-scale activities competently and independently, generating reliable and consistent results.
- Analyze and interpret results, identifying significant trends, observations, and deviations.
- Troubleshoot experiments, instrumentation, and process-related challenges.
- Learn and apply new scientific and engineering techniques as required.
- Execute process development, characterization, and scale-up studies for oral solid dosage forms.
- Demonstrate skill in multiple techniques and appropriately modify protocols to support development objectives.
- Execute designed experiments (DOE) and apply statistical tools to support process understanding.
- Support manufacturing campaigns, scale-up activities, and PPQ batches through on-site technical support.
- Author campaign memos, technical summaries, and development documentation.
- Understand and adhere to corporate standards regarding safety, data integrity, GMP/GxP compliance, and appropriate handling of materials.
Qualifications
- Bachelor's degree with typically 3+ years of relevant experience or Master's degree in Engineering, Pharmaceutical Sciences, or related scientific discipline.
- Theoretical and practical knowledge required to perform assigned job functions.
- Experience supporting development or manufacturing of oral solid dosage forms, including tablets and capsules.
- Knowledge of oral solid dosage form unit operations including blending, granulation, milling, compression, encapsulation, and coating.
- Experience executing laboratory studies in a regulated pharmaceutical environment.
- Working knowledge of process development, scale-up, and late-stage development activities.
- Familiarity with experimental design (DOE) and statistical data analysis.
- Experience analyzing, documenting, and communicating technical results.
- Proficiency with common data analysis and reporting tools.
- Knowledge of GMP/GxP requirements and pharmaceutical documentation practices.
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) for eligible employees
- Eligibility to participate in long-term incentive programs