Senior MSAT Bioprocess Engineer - GMP & Tech Transfer

Theradaptive; Frederick (MD); On-site; USD 108,000 - 139,000; Full time

Job summary

Theradaptive is seeking a skilled MSAT Process Engineer III/IV to join our Manufacturing Science and Technology team in Frederick, MD. This role provides hands-on manufacturing support for GMP operations, leads deviation investigations and CAPA, and collaborates cross-functionally to advance our combination product pipeline.

The successful candidate will apply data-driven problem solving, execute PPQ/CPV activities, and drive process improvements while supporting technology transfer to

Qualifications

• Bachelor’s or Master’s in engineering or related science.
• 4–8 years MSAT/bioprocess/GMP experience in biologics or medical devices.
• Lead deviation investigations, CAPA development, and change control.
• PV/PPQ/CPV experience.
• Tech transfer with CMOs/CDMOs preferred.
• Knowledge of biologics unit operations (cell culture, purification, fill-finish).
• Experience with data analysis and process trending.
• Familiar with FDA/ICH/ISO regulatory frameworks.

Responsibilities

• GMP Manufacturing Support: direct day-to-day manufacturing operations.
• Deviation Management: lead investigations, develop CAPA, ensure closure.
• Process Validation & CPV: own PPQ protocols/reports; apply DOE.
• Technology Transfer: support internal and external transfers; author plans/reports.
• GMP Documentation: write and review deviations, protocols, reports, SOPs.
• Cross-Functional Collaboration: align with QA, QC, Supply Chain, Regulatory.

Skills

Data-driven problem solver

Clear technical communicator

Cross-functional collaborator

Statistical data analysis

Process trending tools

Education

Bachelor’s or Master’s degree in engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or related field

Tools

TrackWise

MasterControl

SPC charting

Job description

Theradaptive is seeking a skilled MSAT Process Engineer III/IV to join our Manufacturing Science and Technology team in Frederick, MD. This role provides hands-on manufacturing support for GMP operations, leads deviation investigations and CAPA, and collaborates cross-functionally to advance our combination product pipeline.

The successful candidate will apply data-driven problem solving, execute PPQ/CPV activities, and drive process improvements while supporting technology transfer to