We are seeking a highly motivated Senior Process Engineer I with outstanding knowledge and hands-on experience in downstream process development and process scale-up. This individual will be responsible for providing technical and scientific expertise to downstream process transfer, scale-up, and GMP manufacturing for Homology's novel and proprietary adeno-associated virus (AAV) viral vectors. Critical to this role, is the ability to effectively communicate scientific findings and innovative solutions with other functions including Process Development, Manufacturing, Engineering, Quality and CMC teams.
- Play a lead role in providing routine person-in-plant support to downstream GMP manufacturing activities
- Support downstream GMP manufacturing batch record review, change controls, deviations, etc.
- Provide technical expertise in trouble-shooting, root cause analysis, and data trending toward continued downstream process improvement
- Act as subject matter expert for technology transfer, scale-up, and process characterization
- Collaborate with internal and external groups to ensure alignment and completion of project objectives and activities
- Author technology transfer and GMP manufacturing campaign reports
- Maintain and update downstream database containing information related to all GMP manufacturing activities; ensure data integrity and traceability
- Support regulatory filings and responses to regulatory questions
- A Ph.D., M.S. or B.S. in Chemistry, Chemical Engineering or related fields with a minimum of 2 (Ph.D.), 5 (M.S.) or 8 (B.S.) years of relevant industry experience
- Previous experience in downstream process development
- Ability to operate cross-functionally with strong communication and interpersonal skills
- Attitude to proactively learn and apply new technologies
- Ability to assist in analyzing complex technical problems, and proposing new solutions
- Willingness to travel both domestically and internationally (up to 15%)