Job Description
Job Summary:
The Downstream Process Development, MSAT department supports several projects including:
- Seasonal strain changes for Flublok/Covid Vaccine.
- Process improvement and optimization projects.
- Yield improvement strategies and implementation.
- Process monitoring and control.
- Manufacturing support for production operations.
Duties and Responsibilities:
- Primary responsibilities are the execution of development studies such as resin reuse, process improvements, optimization, scale-up, column load, and evaluation of yield improvement strategies as outlined by the Deputy Director DSP/MSAT in collaboration with others on projects.
- Executes purification experiments including automated or high-throughput chromatography (AKTA platform), filtration, clarification/ depth filtration, column packing, and tangential flow filtration independently based on expert knowledge of protein purification and analysis with an in-depth understanding of all modes of chromatography.
- Makes detailed observations, analyzes data, and interprets results.
- Exercise technical discretion in the design, execution, and interpretation of experiments that contribute to projects.
- Prepares technical reports, summaries, protocols, and quantitative analyses.
- Responsible for training on, understanding, and following documented procedures that apply to their departments.
- Responsible for general lab maintenance.
- Proactively anticipates and effectively communicates successes, constraints, solutions, and actions for resolution.
- Fosters relationships with partners, experts from other functions, and customers to achieve technical objectives.
- Perform troubleshooting as required, and supports staff.
- Demonstrate and promote company values and competencies through daily actions and decisions.
- Contribute to strategic planning for downstream process development initiatives.
Education and Experience:
- Bachelor’s or Master’s in Biology, Biomedical, Biotechnology, Biochemistry, or similar discipline.
- 2 – 6 Years of Experience.
Core Competencies:
- Fluent in English (written and verbal communication).
- Good communication and interpersonal skills.
- Excellent team member spirit.
- Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint).
Preferred Qualifications:
- Operating, maintaining, and troubleshooting chromatography workstations and process skids.
- Analyzing Data with Assay (SDS PAGE and Western Blot, SRID, BCA, Purity, Dialysis for rBV, ELISA, etc.)
- Knowledge and experience working with automated high throughput process development equipment.
- Demonstrates working knowledge of scientific principles and concerns.
- Participates in quality control tracking systems including change controls, deviations, CAPA, root cause analysis, etc.
- Maintains project timelines.
- Good documentation practices (GDP). Experience in writing standard operating procedures (SOP), batch records, and reports.
- Hands-on experience with molecular modeling software is desirable but not required.