Location: Thousand Oaks, CA
Job ID: amge-00024814
B.S. with 10-15 years in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or Life Sciences. Must have experience with parenteral drug product manufacturing processes of vaccines or protein/antibody, including process characterization, technology transfer, and/or manufacturing support/troubleshooting.
With guidance apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and/or engineering (fluid mechanics, heat/mass transfer, etc.) principles to resolve processing issues and product impacting non-conformances, as well as evaluating changes such as process improvements, equipment, scale, and raw materials
Have the ability to participate in global cross-functional team and work effectively in a highly matrixed team environment. Interact with representatives from Analytical Sciences, Pharmaceutics, Purification Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality to arrive at viable / practical solutions, as well as implement those recommendations.
Basic project management skills, to include the ability to prioritize critical vs. non-critical issues, clear and timely elevation of critical issues to line-management & team leaders, and management of project resource requirements (material, manpower, time, etc.).
M.S. with 5-10 years or Ph.D. with 0-5 years in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or Life Sciences. With a pharmaceutical, vaccine, or biotechnology background as mentioned above. Apply fundamental scientific and engineering principles to resolve processing issues such as product impacting non-conformances and process improvements. Have the ability to lead a global cross-functional team and work effectively in a highly matrixed team environment, interacting with multidisciplinary team members to arrive at viable / practical issues to resolution and implementation. Project management skills, with the ability to manage team resource requirements, elevate relevant issues, and present to line-management.
The candidate would be expected to act as a lead for a Pre-Commercial drug product program within process development to achieve the resolution of significant / high-impact technical issues.
The candidate would lead a team in troubleshooting of the following commercial drug product manufacturing operations: drug substance freezing/thawing, formulation (process), filling vials/syringes/devices, lyophilization (if necessary), inspection, and transportation, for protein parenteral (injectable/infusion) products.
The candidate would contribute to the resolution of product impacting non-conformances in commercial drug product manufacturing, as well as support commercial manufacturing changes such as process improvements, equipment, scale, and raw materials.
As necessary, the candidate would support the expansion of manufacturing operations to enhance production capacity. Act as a technical lead on a cross functional team executing the technology transfer of the commercial drug product manufacturing process, including participation in the commercial manufacturing site selection (world-wide), equipment selection, designing commercial process flow, contribute to the master validation strategy, authoring process transfer documentation, critically reviewing the necessary GMP documentation, etc.
As necessary, the candidate would support the development of new commercial drug product formulations and or presentations. Lead the process design, scale-up, characterization, and technology transfer, of these new formulations and/or presentations. Again, including site selection (world-wide), equipment selection, process design, validation strategy, and relevant GMP documentation.
The candidate would be expected to keep current on the latest industrial/scientific and regulatory trends (i.e. FDA process design-space philosophy) to deliver a robust commercial process back by concrete scientific findings, as well as authoring and reviewing all relevant sections of global regulatory filings.
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