Description
Design, develop, scale up, and validate pharmaceutical manufacturing processes and equipment for drug substances and drug products, applying chemical/biochemical engineering under cGMP to ensure quality, safety, and regulatory compliance.
- • Develop cGMP safety, containment, and aseptic procedures for handling APIs, solvents, and high-potency compounds.
- • Determine optimal sequence and conditions for unit operations such as synthesis/fermentation, crystallization, filtration, drying, granulation, blending, compression, coating, and sterilization.
- • Prepare cost, yield, and capacity estimates and production progress reports for management.
- • Direct and support commissioning, qualification (IQ/OQ/PQ), cleaning validation, and operation of equipment such as bioreactors, centrifuges, chromatography skids, granulators, tablet presses, and lyophilizers.
- • Perform laboratory and pilot-scale studies; use DoE/QbD to develop and scale processes.
- • Develop purification and formulation processes, including crystallization, membrane filtration, and chromatography.
- • Conduct research to improve drug substance and drug product manufacturing, develop continuous manufacturing, and support process validation.
- • Design and implement control strategies and PAT for monitoring CPPs and CQAs.
- • Plan cGMP facility and equipment layouts, cleanroom classifications, and material/personnel flows.
- • Troubleshoot process deviations; lead root cause analysis and implement CAPA.
- • Evaluate equipment and processes to optimize yield, robustness, and reliability while ensuring compliance with FDA/EMA and EHS regulations.
- • Perform in-process testing and monitor critical variables such as temperature, pH, dissolved oxygen, particle size, moisture, and pressure across production stages.
- • Monitor, analyze, and report process and experimental data using statistical tools to support tech transfer and validation.
Related specializations
Interview options
Interview options
Interviewee gender
Interviewee accent
Interview time
Related Pathways
Advanced Manufacturing
View
Source
Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
Learn more
Sources & Standards:
This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
