In this role, you will drive the development of Container Closure Systems (CCS) for new parenteral products supporting some of AbbVie’s most important pipeline assets, including monoclonal antibodies, antibody-drug conjugates and therapeutic toxins. You are an expert in the characterization of CCS (vials, prefilled syringes, prefilled cartridges) with a strong focus on Container Closure Integrity (CCI). Your work includes development and validation of CCI methods, technical support for CCS qualification in pharmaceutical manufacturing, and the evaluation and implementation of innovative CCI technologies. 

Your responsibilities are:

• Plan, prepare, execute and evaluate experiments for the development of container closure systems for new parenteral drug products, focusing on liquid biotechnological drug products in vials, prefilled syringes and cartridges, including scale-up activities

• Act as a subject matter expert for the technical evaluation, development and continuous improvement of CCI methods based on a holistic CCI strategy and current regulatory as well as economic considerations

• Initiate and supervise collaborations with internal and external partners (for CCI method development, technique implementation and characterization based on various CCI technologies and data)

• Ensure compliant documentation of all experimental work and contribute to the preparation and review of internal procedures

• Prepare and review technical documents, such as method development reports and risk assessments, that may serve as source documents for regulatory filings, method transfers and related activities