Overview:
This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. The candidate will establish themselves in a Shift lead role, providing process development oversight while supporting Engineering runs and PPQs in the manufacturing vial or syringe suites.
In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization.
Responsibilities would include the following:
- Supports new product introductions to PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME on the floor for these product and project executions.
- Support activities to deliver success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
- Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.
- Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer
- The NPI Shift Engineer will support Process Development activities on the floor during executions. The NPI Shift Engineer will support the NPI projects on days when not executing runs. The NPI Shift Engineer will have a responsibility to lead Continuous Improvement projects to improve the NPI process.
The position will report to Process Development Engineering Manager. Moderate international travel might be required during the course of the project.
Key Responsibilities:
- Development of validation plans, process performance qualifications for vial and syringe filling.
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
- Act as the responsible point contact on site for the transfer project for drug product teams.
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
- Collate and report on relevant shipping and filter validation.
- Assist in deviation and exception resolution and root cause analysis.
- Contribute to product quality assessments and process flow documents.
- Lead Continuous Improvement initiatives for the NPI team
Basic Qualifications:
- Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
Preferred Qualifications:
- Masters in Science or Engineering.
- 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.
