This role will require the candidate to provide process development support primarily to the Forensics and Defect Laboratory. The candidate will establish themselves as an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.
Responsibilities would include the following:
* Leads / assists forensic investigation and identification of defects arising from drug product manufacture at ADL and write up of these investigations to cGMP standards.
* Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment at ADL.
* Working as part of the PD laboratory team be expected to contribute to upkeep / maintenance of a GMP laboratory environment.
* Provide process development expertise for commercial drug product particle / defect identification and contribute to the maintenance of local and global particle / defect libraries.
The position will report directly to Process Development Principal Engineer.
* Perform experiments, organise data and analyse results with minimal supervision (in a GMP laboratory environment) to evaluate product impact due to process variables encountered during drug product manufacture.
* Creation, Management and Maintenance of Inspection defect panels / sets.
* Execution of Knapp studies and data analysis.
* Establish experimental design, develop and implement protocols, obtain reproducible and reliable results and communicate data to cross functional groups.
* Ensuring all aspects of laboratory activity adheres to required policies and procedures, including safety and training.
* Ensure that the laboratory and site meet the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
* Participate in cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones.
* Assist in deviation and exception resolution and root cause analysis.
* Third level bachelor's degree in science, engineering or a relevant quality discipline with 2 - 4 years' experience in a similar role OR Associate's degree and 5 years of directly related experience.
* Experience in Working in a Laboratory Environment.
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written communications skills.
* Masters in Science or Engineering.
* Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, inspection, tech transfer (to commercial DP sites) or validation.
* Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy).
* Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods.
* 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.
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