Lead Scientist, Downstream

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

The Downstream Lead Scientist will be responsible for designing and implementing robust, scalable, and efficient manufacturing processes. Key responsibilities include technology transfer and process validation in clinical and commercial manufacturing projects. The individual will provide technical expertise and leadership with close collaboration throughout the organization.

General Responsibilities

• Lead technology transfer for cGMP manufacturing of pDNA, Viral Vectors, and Recombinant Protein in MO Expression System.
• Collaborate with other sites or clients to ensure success of process transfer and scale up.
• Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.
• Author detailed process definition and facility fit assessment exercises.
• MST process lead for Downstream process, ensuring the materials, strategy and documentation are in place.
• Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials and process intermediates.
• Execute process establishment runs and small-scale experiments, ensuring the materials, strategy and documentation are in place.
• Execute scale down model of manufacturing processes.
• Author and maintain process control strategy documents throughout the lifecycle of a program.
• Author and maintain process risk assessment documents.
• Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities.
• Support engineering teams on equipment selection, qualification, and start up activities.
• Develop sampling plans with clients and incorporate them into cGMP batch documentation.
• Monitor and trend process performance, including input and output parameters.
• Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
• Identify opportunities to improve systems and practices.
• Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.

Requirements

• MS in Biochemical Engineering, Chemical Engineering, Molecular Biology or related scientific discipline.
• +5 years of experience in a downstream scientist role, or equivalent, with the ability to lead a team of scientist.
• Proven project management experience is required.
• Technical expertise in downstream biotech manufacturing and/or process development.
• Experience with a variety of at-scale filtration chromatography and column purification methods including TFF, depth filtration, affinity, ion exchange and size exclusion chromatography as well as other applicable analytical methods for process characterization.
• Experience in late stage/commercial technology transfer, process characterization and process validation.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
• Knowledge of recombinant protein production highly desirable.
• Knowledge of pDNA production highly desirable.
• Knowledge of viral vector production highly desirable.
• Ability to work both independently and as part of a team.
• Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects.
• Laboratory skills and the ability to be hands-on.
• Excellent troubleshooting skills and ability to solve complex technical issues.
• Ability to compile, analyze and interpret data.
• Ability to write routine reports and correspondence.
• Strong interpersonal and communication skills, verbal and written.
• Ability to speak effectively before groups of customers and to communicate in a dynamic environment.