The candidate for this position will perform process development for viral and cell based products such as cell therapy, gene therapy and vaccines within the API-Large Molecule group in Spring House, PA.
The candidate’s primary responsibilities will include participating in design of experiments, executing the planned experiments, optimizing purification process steps, and data analysis for early and late stage products.
The candidate will contribute to design and execution of the development studies to identify and determine process parameter ranges for process steps.
Additional responsibilities include:
- Provide technical assessment to others and enable decision making to set drive the project
- Take lead role to transfer process from development to GMP clinical and commercial manufacturing as process SME
- Record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and also write technical documents
- Work in a team environment as well as contributing individually to meet project timeline and objectives
- Bachelors in Chemical Engineering or Biological Sciences or Biochemistry with 7 years of relevant experience OR MS in Chemical Engineering or Biological Sciences or Biochemistry and with at least 5 years of relevant experience is required
- Broad knowledge in purification process development is preferred
- Hands-on experience in one or more of the purification process development steps – cell recovery, chromatography operations, and UF/DF is preferred
- Previous experience in scale-up and transfer of a purification process to clinical and commercial GMP manufacturing is preferred
- Familiarity with upstream or downstream process development of viral based products is required
- Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of viral based products is preferred
- Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required
- Experience with team-based collaborations is required
- Occasional weekend work and up to 10% travel is required
Requisition ID: 9524180112