Job Details

Job Type

Full-time

Description

SUMMARY

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.

JOB RESPONSIBILITIES

ESSENTIAL FUNCTIONS

• 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 perform a series of bench scale experiments such as sterile membrane filtration, depth filtration, tangential flow filtration, viral clearance filtration, as well as chromatography.
• Develop and recommend 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.
• Effective communicator of ideas, project goals and results across functions.
• Interacts with management on advanced technical matters.
• Authors and reviews regulatory filing documentation as well as process validation and characterization reports. Authors internal reports at appropriate milestones.

• 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.