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Generate Process P&IDs (preferably on AutoCAD) that include controls strategy and CIP/SIP functions, if appropriate. Also, generate P&IDs for critical utility systems, such as WFI, USP Purified water...
Leading the formulation efforts in the design, development, and implementation of phase appropriate drug product processes to successfully support preclinical and clinical studies...
Develop bench scale protein purification methods for clinical candidate lead molecules which include antibodies, bispecifics and antibody drug conjugates...
Extensive hands-on experience in the optimization and execution of protein purification of recombinant proteins and antibodies using various chromatographic systems such as AKTA, Waters, Shimadzu, and...
Small and large (biological) drug molecule formulation and process development experience required. Understanding of sterile injectable drug product manufacturing processes is essential...
Interpret and disseminate information on new regulations related to the NPDES; assists in implementing new features of the Program as required by new regulations...
Establish and maintain excellent working relationships with clients and members of the IPS design team.Perform engineering studies for expanding, improving or automating existing facilities with limit...
Pro-actively monitors the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape and assesses the potential impact on the regulatory and/or business st...
The successful candidate will plan, implement and analyze in vivo immuno-oncology studies to define the mechanism of action of novel agents and progress programs to IND and into the clinic. This posit...
This individual will be responsible for the development and implementation of both Clinical Pharmacology and Modeling and Simulation (M&S) strategies in support of our portfolio...
Leading the process chemistry efforts in the design, development, and implementation of phase appropriate and robust synthetic processes to successfully deliver preclinical and clinical drug substance...
Analyze workflows, identify bottlenecks, and develop solutions to improve efficiency, throughput, cost, and quality. Manage a team of engineers and technicians. Includes having oversight over the hiri...
Manage a small team of bioprocess engineers, associates, and technicians. Define and implement improvements to our operating procedures and writing new protocols when necessary...
Author technical reports in support of analytical and microbiological development and process development activities