Associate Sr Consultant Engineer

Mô tả công việc

The Process Design and Development group is responsible for the chemistry, formulation, analytical and engineering efforts to support development and scale-up of investigational small molecules to support clinical and toxicology studies through late stage clinical trials. It is also responsible for development of the continuous processing and solid state design capabilities. Through application of scientific training and relevant experience, a team of scientists design needed chemistry, formulation, engineering, and analytical solutions based on the strategy designed for each molecule. Additionally, they support the clinical manufacturing and commercialization of new drug candidates.The Research Scientist / Engineer – Continuous Manufacturing: Designs and develops chemical routes and analysis methodology and / or unit operations intended for use in continuous processing, or formulations for the development portfolio. Works with internal and external manufacturing partners to develop chemistry capabilities and/or to ensure that developed formulations are amenable to a continuous manufacturing platform. Collaborates with developability, vTeam, or dTeam resources to ensure alignment across portfolio and incorporation of patient centric design into our drug products.Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participates in the establishment and maintenance of SMDD Quality systems.Contributes to, leads and/or supervises the process development and/or control strategy of drug substance and/or drug product. Typical responsibilities include:Development of the manufacturing processes and control strategies for drug substance and/or drug product.Technology transfer to manufacturing.Preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions.Writing and timely completion of technical reports and regulatory documents.Demonstrates the Lilly Leadership behaviors, as defined in the Lilly Performance Management system.Plans and manages short term and long term development activities. Assigns work to be done, coordinates, evaluates, and reviews the activities of personnel assigned to the group.Develops or reviews plans and timetables for project work. Recommends the resource allocation to accomplish projects according to plans, updates and communicates progress, and proposes changes in project timetables, objectives, or direction.Takes leadership in the supervision of the compliance of this department with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.Authors, reviews or approves high quality technical reports and regulatory submissions dealing with the work performed by the department. Ensures that records and technical notebooks are adequately maintained.Helps ensure that people, and their environment are safe and that company policies concerning safety are followed.