Senior Process Engineer - Chemical

The Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.This role will: Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical productEvaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysisPropose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scalePropose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous productTake an active part in scale-up and technology transfer of newly developed products from R&D to manufacturingIdentify and order materials required to perform development and manufacturingIdentify tooling and equipment required to perform development and manufacturingCreate documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standardsDue diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and qualityPropose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug productCompile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctionsAnalyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical productMaintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when neededStudy effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical productDevelop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical productWrite technical papers or reports or prepare standards and specifications for processes, facilities, products, or testsProvide leadership in daily operations, and have employees incorporate these compliance practices into their daily routinesLead/support validation activities including equipment validation and process validationLead problem solving and investigate quality events related to formulation process or batch recordsPropose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standardsLead or participate in root cause analysis and quality event investigation such as OOS and deviationsSupervise, mentor and develop team members or relevant personnel across departmentsThis role requires:A minimum of three (3) years of experience in pharmaceutical research and manufacturingBachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical ScienceExperience in sterile manufacturing is preferredExperience in lyophilization and terminal sterilization techniques are a plusKnowledge of parenteral drug product manufacturingProficient with calculation, data analysis, statistics and applied mathematics