MSAT Bioprocess Engineer III / IV

About the role

Theradaptive is seeking a skilled and driven MSAT Process Engineer III/IV to join our Manufacturing Science and Technology team. This role will provide hands-on technical leadership and manufacturing support for GMP operations, lead deviation investigations and CAPA activities, support process validation and continued process verification (CPV), and partner cross-functionally to advance Theradaptive's combination product pipeline. The successful candidate will bring strong technical judgment, a data-driven approach to problem solving, and the ability to translate process knowledge into robust, compliant, and scalable manufacturing solutions.

Travel requirement: Up to 10%, primarily to support CMO/CDMO technology transfer activities.

Responsibilities

• Serve as the primary technical point of contact for day-to-day GMP manufacturing operations.
• Monitor real-time manufacturing activities, troubleshoot process issues, and drive timely resolution of technical challenges.
• Ensure manufacturing processes remain continuously aligned with cGMP requirements and applicable regulatory expectations.
• Lead and independently author deviation investigations, applying structured root cause analysis (RCA) methodologies (e.g., 5-Why, Fishbone, FTA).
• Develop and track robust CAPA plans; assess effectiveness and drive closure in a compliant and timely manner.
• Manage change control activities, evaluating technical impact and ensuring thorough documentation.
• Own and execute process validation activities including Process Performance Qualification (PPQ) protocols and reports.
• Apply Design of Experiments (DOE) principles to support process characterization, parameter optimization, validation strategy, and establishment of robust process control ranges.
• Analyze CPV metrics and process datasets to proactively identify trends, risks, and opportunities for improvement.
• Support product lifecycle management and post-approval change activities.
• Lead or support technology transfer activities between process development, internal GMP manufacturing, and external contract manufacturing organizations (CMOs/CDMOs).
• Author and review technology transfer plans, batch records, and technical reports to ensure manufacturing readiness.
• Drive process scale-up and process improvement activities by translating development-scale processes into robust, scalable, and GMP-ready manufacturing operations.
• Author, review, and approve GMP documentation including deviations, technical reports, validation protocols/reports, change controls, and SOPs.
• Maintain high documentation standards consistent with regulatory expectations and internal quality systems.
• Partner cross-functionally with Manufacturing, QC, QA, Supply Chain, and Regulatory teams to drive compliant, efficient operations.
• Champion continuous improvement initiatives and apply process excellence principles to manufacturing performance.
• Participate in audit and inspection readiness activities, including preparation of technical summaries and subject-matter expert support.

Qualifications

• Bachelor's or master's degree in engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• Minimum 4–8 years of progressive experience in MSAT, Bioprocess engineering, or process development, GMP manufacturing support in biologics or medical devices.
• Demonstrated ability to independently lead deviation investigations, CAPA development, and change control activities.
• Hands-on experience with process validation (PV), Process Performance Qualification (PPQ) and CPV programs.
• Prior involvement in technology transfer activities, including transfers to or from CMO/CDMO partners, preferred.
• Working knowledge of biologics unit operations, including one or more of the following:
  • Cell culture (mammalian, microbial, or primary cell systems)
  • Downstream purification (chromatography, filtration, centrifugation)
  • Formulation and fill-finish operations
• Experience with statistical data analysis, SPC charting, and process trending tools.
• Familiarity with regulatory frameworks including FDA 21 CFR Part 211/600, ICH Q8/Q9/Q10, and ISO standards.
• Proficiency with GMP documentation systems (electronic or paper-based) and quality management systems (e.g., TrackWise, Master Control).
• Data-driven problem solver with strong scientific judgment.
• Clear technical communicator and cross-functional collaborator.
• Detail-oriented, accountable, adaptable, and improvement-minded.

Physical demands

• Ability to work in classified cleanroom environments and meet all applicable gowning and PPE requirements.
• Capacity to stand for extended periods and perform repetitive technical tasks in a GMP setting.
• Ability to lift and handle laboratory equipment and supplies as required.

Compensation

$108,000–$139,000 annually, based on qualifications and level.

Location

On-site at Theradaptive's corporate headquarters in Frederick, MD.