Job Description
**Job Summary**: Forensic Process Development Specialist required to provide expert support to Forensics and Defect Laboratory, identifying drug product defects, and developing process development expertise for commercial drug product particle and defect identification. This role will require the candidate to provide Process Development (PD) support primarily to the Forensics and Defect Laboratory within an innovative biopharmaceutical company. 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 will include: * Leading and assisting forensic investigations and identifications of defects arising from drug product manufacture, and writing up investigations to cGMP standards. * Being accountable for the maintenance, distribution, and upkeep of extensive defect panels used for the setup, training, and characterization of automated / semi-automated / manual finished drug product visual inspection equipment. * Providing process development expertise for commercial drug product particle / defect identification and contributing to the maintenance of local and global particle / defect libraries. Key Responsibilities: * Performing experiments, organizing data, and analyzing results with minimal supervision in a GMP laboratory environment to evaluate product impact due to process variables encountered during drug product manufacture. * Creating, managing, and maintaining inspection defect panels / sets. * Executing Knapp studies and data analysis. * Establishing experimental design, developing and implementing protocols, obtaining reproducible and reliable results, and communicating data to cross-functional groups. * Ensuring all aspects of laboratory activity adheres to required policies and procedures, including safety and training. * Ensuring the laboratory and site meet the quality requirements of its customers and applicable regulations (FDA, EU & international standards). * Participating in cross-functional teams at the site to ensure adherence to required policies and procedures and being responsible to deliver against organizational goals and project milestones. * Assisting in deviation and exception resolution and root cause analysis. Basic Qualifications: * 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. Preferred Qualifications: * 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. * Familiarity 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. Shift Details: * 20% shift premium. * One week: 07:00 to 15:00 Mon - Thurs, 07:00 to 14:00 Fridays. * Second week: 14:30 to 22:30 Mon - Thurs, 13:00 to 20:00 Friday.