- Work with interdisciplinary team members to design,develop and optimize manufacturing processes for therapeutics within the IO space such as cancer vaccines.
- Analyze, interpret, and present experimental data to communicate results and continuously improve process performance and understanding.
- Responsible for high quality of documentation, laboratory notebooks, protocols, development reports, tech transfer reports, engineering studies, etc.
- Stay current with industry standards and trends. Evaluates new technologies, procedures, and technical developments.
- Perform process/tech-transfer for assigned projects and supervise projects over time while interfacing with GMP team to support change control efforts for implementation.
- Responsible for performing the process evaluation and facility fit including materials, and identifying required equipment for new processes to be implemented in the GMP-manufacturing facility.
- Perform scale-up with required adaptations and process improvements
- Plan process-transfer activities according to timeline and quality
- Work with facilities to ensure optimal process design for maximal facility output to support competitiveness
- Discuss and present results to internal or external customers to successfully transfer processes
- Plan back-up strategy for transfer campaigns
- Perform technical assessments
- Support filing documents, write and review sections within CMC dossiers
- Process Monitoring/Trending
- Monitor, analyze and evaluate process data and trends
- Closely collaborate with Process Science on internal improvement projects
- Create campaign/summary reports
- Conduct complex trouble shootings related to production (e.g., technical, equipment, and process performance issues, including planning of small-scale testing in collaboration with PS)
- Ensure that investigations are consistent with manufacturing practices (process and methods), policies and complying with external regulatory requirements.
- PhD with a focus in Biopharmaceuticals and/ Bioengineering or relevant technical field and 6-10 years of professional experience or equivalent.
- Basic knowledge and understanding of upstream cell culture processes, experience in E. coli manufacturing a plus
- Enthusiastic, team player with passion for growth and innovation. Excellent oral and written communication skills.
- Demonstrated technical proficiency and creativity, with proven ability to independently design and execute experiments.
- Excellent organizational and time management skills.
- Project Management experience is highly desirable.
- Solid oral and written communication skills, including technical report writing and presentation abilities.
- Must be able to effectively work well in a cross functional team environment.
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