Overview
Role based out of Dublin as part of the global Process Development organization. The candidate will support manufacturing at various aseptic drug product contract manufacturing sites around Europe. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production. Depending on assignments, the candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials) and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more Client modalities) across multiple manufacturing sites. International travel will be required to visit contract manufacturing partner sites in Europe.
Responsibilities
* Develop as a drug product technical expert to provide leadership and solutions for troubleshooting parenteral drug product manufacturing across all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices for parenteral products through the new product introduction (NPI) or commercial phases.
* Collaborate with contract manufacturing partner SMEs, Global Operations, Contract Manufacturing Quality and drug product process teams.
* Work as a member of cross-site teams to support contract manufacturers and identify and resolve potential issues.
* Provide process development expertise for commercial drug product processing in areas such as aseptic processing, process characterization, technology transfer, and process validation.
* Troubleshoot issues with drug product processing technologies and equipment.
* Identify and implement operational improvements for current and new sterile operations.
* Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
* Visit contract manufacturing sites to observe production operations and build relationships.
Qualifications
* 5-8 years' pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment.
* Knowledge of cGMPs.
* Proven problem-solving ability.
* Excellent oral and written communications skills.
* Strong academic results in a Bachelor's degree in Science, Engineering or a relevant quality discipline.
* Full clean driving licence required to facilitate travel.
* Language skills such as Italian or German.
* Masters or PhD in a Science or Engineering or related discipline.
* Experience with aseptic drug product processes (component preparation, sterile filtration, filter integrity testing, filling, capping, visual inspection).
* Experience with aseptic drug product presentations (pre-filled syringes, cartridges, lyophilised vials and liquid vials).
* Experience with quality testing methods and interpretation of results for biological molecules.
* Aseptic drug product validation experience (e.g., media fill, sterilisation validation, equipment qualification, process validation).
* Experience dealing with contract manufacturing organisations.
* Project management experience.
* Demonstrated ability to lead and take responsibility.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Project Management
Industries
* Pharmaceutical Manufacturing
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