Manager, Analytical Process Development

AGC Biologics is seeking a Manager, Analytical Process Development to lead the development of analytical methods in support of client projects and technology transfers across sites. This role will also involve leading a team of associates and scientists, performing cell and gene therapy analytical assay development, evaluating external analytical technologies, and managing external collaboration projects. The Manager will work collaboratively within the PD organization, cross-functionally across the QC organization, and internationally with the European sister facility in Milan, Italy.

• Develop the tactical work plan for a team of Associates/Scientists to support PD and site activities including analytical transfer and method development.
• Coach, guide, and mentor staff members on technical aspects of analytical development as well as personal behaviors.
• Perform cell and gene therapy analytical assay development for potency, identity, chemical and physical characteristics, safety, and impurity (viral titer and infectivity, PCR and gene sequencing, clarity, pH, osmolality, residual host cell and plasmid proteins, Elisa, etc.); provide internal process analytical supports, and lead method transfer to process development and QC teams.
• Fully participating in the design and execution of experiments aimed at delivering on the departmental vision and in collaboration with AGC Biologics PD and QC personnel.
• Working collaboratively within the PD organization, cross-functionally across the QC organization, as well as internationally in collaboration with the European sister facility in Milan, Italy to share knowledge and expertise fluidly across the sites.
• Evaluate external analytical technologies and manage external collaboration projects.
• Lab management (e.g. coordinating instrument training and maintenance, consumable ordering) as required of the role.
• Day-to-day operations required to support the analytical development work in Longmont, Colorado.
• Interaction with clients as needed to explain complex methods and provide technical support to the Business Development.

• Excellent knowledge and experience in analytical method development for the characterization in biotech industry
• Ability to manage work tasks for self and others and motivate team to complete projects in accordance with timelines and deliverables
• Strong interpersonal and team skills, including the ability to work collaboratively in a fast-paced cross functional environment
• Strong data management skills and attention to detail in the execution and documentation of studies
• Good mechanical aptitude and confidence working with computers and analytical equipment
• Excellent written & oral communication skills and technical ability
• Proven technical ability to successfully problem solve and troubleshoot
• The ability to work with limited supervision and in a team setting
• Willingness to support limited evening and weekend work, as needed
• Able to lift 30 pounds and have good physical health.