Sr. Scientist, MSAT
The MSAT Sr. Scientist's primary responsibilities are to provide scientifically sound innovative strategies and validation approach to existing and new processes through its lifecycle. This requires strong scientific knowledge (both theoretical and practical) in recombinant protein development and manufacturing to understand how changes or variants may impact product quality. The MSAT Sr Scientist provides analysis of data from both internally and externally generated sources to provide recommended strategies.
Technical Duties/Responsibilities & Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Communicate with clients on proposed strategies and process assessments
- Evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.
- Prepare analysis and reports of proposed changes that are based on sound scientific and engineering principles.
- Perform statistical analysis of data to form conclusions and recommendations.
- Author Technical Reports and Process Validation Protocols
- Provide scientific justification for risk assessments and product impact statements. Provide technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
- Perform proper scale-up assessments to translate executed PD-scale process into Manufacturing scale.
- Recommend and drive improvements in equipment, processes, and systems to increase efficiency and reduce risk.
- Monitor Process Health through process monitoring.
- Assist in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions.
Position Type/Expected Hours of Work:
This role is a full-time exempt Monday - Friday position. Must be available to work holidays, weekends or extended hours if necessary to support production schedule. Will consider remote candidates who can work periodically onsite.
Education and/or Experience:
- PhD or M.S. in scientific or engineering (chemical, mechanical or biomedical) discipline. Minimum 5-10 years of biologic manufacturing process development.
- Demonstrated track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.
- Strong knowledge of cGMPs or equivalent standards.
- Ability to make sound decisions to resolve or escalate deviations and/or issues on the production floor.