About the position
Responsible for all aspects of purification process development from process definition to process characterization for support of pipeline projects. Designs a series of experiments that contribute to project objectives. Develops new processes and technologies to achieve improved product quality and reduce production cost. Interacts with management on advanced technical matters.
Responsibilities
- Applies engineering and scientific principles in the process definition, process optimization, scale-up, technology transfer, process characterization, and process validation activities associated with the purification of biopharmaceuticals.
- Designs, implements, and conducts a series of scientific experiments which contribute to project objectives.
- Leads troubleshooting processes, instrumentation, and equipment.
- Serves as a technical resource in technology transfer from process development to clinical cGMP manufacturing including definition of bill of materials, batch record drafting/review, and discrepancy resolution.
- Serves as a process development representative during purification operations.
- Provides technical troubleshooting and recommends process equipment improvements.
- Designs and performs a series of bench scale experiments such as sterile membrane filtration, depth filtration, tangential flow filtration, viral clearance filtration, as well as chromatography.
- Develops and recommends new processes and technologies to achieve cost effectiveness and improved product quality.
- Proactively identifies purification issues and suggests solutions.
- Consistently demonstrates scientific leadership in the laboratory.
- Collaborates with cell culture, formulation, analytical, MSAT, Quality, and Validation for achievement of project objectives.
- May manage external collaborators.
- Effectively communicates ideas, project goals and results across functions.
- Authors and reviews regulatory filing documentation as well as process validation and characterization reports.
- Authors internal reports at appropriate milestones.
Requirements
- BS with 9 years’ experience, MS with 6 years’ experience, or PhD with 0 years’ experience in purification within a pharmaceutical process development group with a degree in chemical/biochemical engineering, biochemistry, or related scientific discipline.
- Proficient in programming, operating, and troubleshooting the following chromatography systems: AKTA pure, AKTA ready, and AKTA pilot.
- Proficient in designing and conducting chromatography development studies.
- Proficient in designing and conducting filtration studies using Scilog FilterTec and labscale TFF systems.
- Understands purification process design limits for implementation in a clinical manufacturing environment.
- Initiates, designs, and executes experiments independently.
- Capable of independent data interpretation.
- May apply advanced modeling or statistical analysis tools where appropriate.
- Highly skilled communicator of ideas, project goals, and results.
- Capable of working effectively in teams.
- Knowledge of cGMP and familiarity with large scale manufacturing support.
