Senior Scientist Downstream Process Development
Cartwright James are exclusively partnered with a pioneering CDMO. They are now seeking a highly motivated expert in development of viral vaccines and viral vectors purification processes.
Most of the projects are related to viral vaccines and viral vectors development and the DSP team collaborates closely with the upstream processing and assay teams in a number of large process development projects which are executed according to aggressive timelines.
The ideal candidate will show entrepreneurial spirit, independence and ability to take strategic, calculated risks to guarantee efficient progression of the projects and build the team and the US operations.
- Guide technical strategies for purification process development to support pre-clinical and clinical programs at all development stages, including process development, optimization, technology transfer, and process characterization of cGMP viral vaccines and viral vectors processes;
- Take responsibility for the design and execution of purification process development studies;
- Independently design, execute and interpret purification experiments including clarification, tangential flow filtration, column packing, and chromatography;
- Demonstrate experience with viral process validation and scale down models for biopharmaceutical processes, including review and interpretation of results;
- Demonstrate expert knowledge of scale up principles with respect to virus purification;
- Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors;
- Author Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in pre-IND, IND, or equivalent regulatory submission;
- Must be familiar with BSL-II lab safety requirements;
- Lead technology transfer and technical oversight of processes to cGMP facility;
- Participate in multi-disciplinary projects with multi-cultural teams, and guide project and business strategies;
- Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance, and manufacturing teams;
- Exercise judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget;
- Manage, train, guide and coordinate activities of junior staff members;
- Update group members on background and status of projects by giving oral updates or internal presentations;
- Actively seek opportunities for continuous improvement;
- Assist other departments and performs all other duties as assigned.
EDUCATION AND EXPERIENCE:
- S. or M.S. in life sciences, chemical engineering, biochemistry or related fields
- 10+ years of experience working in a biopharmaceutical laboratory focusing on viral vaccines and viral vectors purification process development
- Demonstrated understanding of cGMP process development and production
- Experience operating in early stage clinical to commercial environments, as well as contract development and manufacturing
- Demonstrated history of strong hands-on ability, problem solving, and independent experimental design and execution
- Demonstrated technical proficiency and knowledge of scientific concepts
- Ability to adapt to change and effectively deliver under pressure and time constraints, while maintaining a high level of work quality
Job Reference: SC - CDMO73