Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.
The BioProcess Engineer is a Subject Matter Expert (SME) with the demonstrated advanced knowledge and understanding of scientific concepts, practices, and procedures within the biopharmaceutical cGMP environment. This role is a key position for MTEM and the successful candidate will significantly impact and inform our bioprocesses used to produce engineered toxin bodies. This is an exciting and dynamic opportunity for you to contribute to the development of new principles and concepts and to be challenged and lead change from an engineering perspective.
Job Responsibilities will include:
Serve as SME on Biologics Process Science within the Process Sciences group- sharing best practices, technical know-how and adding significant value to the group
Work across one or more core functions/scientific discipline, both within the department and across the site/company
Execute technical and scientific projects and initiatives including study plan and execution, writing technical reports, data analysis and interpretation to support development and manufacturing activities
Ensure quality and effectiveness of key results of major projects through sound design, early risk assessments, and implementation of fall-back strategies thereby mitigating risk
Conduct study protocols, data analysis, reports and standard operating procedures (SOPs) that support development and manufacturing activities
Participate in team efforts developing the drug product process for products within the MTEM pipeline
Provide SME troubleshooting expertise/support on projects or significant process related technical issues in upstream, downstream, fill/finish, and various analytical methods
Respond technically for quality system responsibilities: process-related investigations; product impact assessments, change control assessments, CAPA assessments, etc
Execute studies and reports relating to process understanding, characterization, validation and conducting validation of manufacturing and test methods
Participate as technical expert in site regulatory inspections as needed
Generate Intellectual Property (IP) as process owner
Present data/project updates to management and inter-departmental teams
Bachelors' Degree in Chemical/Biochemical Engineering, with a minimum 5 years of related experience required in Biologics Processes (upstream, downstream, and fill/finish) or equivalent combination of education and experience
Expert knowledge of scientific principles and concepts
Experience in process development, technical transfer, scale-up, and process validation activities related to various unit operations (e.g. fermentation, downstream processing, formulation/fill/finish)
Demonstrated success in independent judgment, technical proficiency, scientific creativity, collaboration with others in a cGMP environment
Experience in Risk Assessments for biologics projects
Experience performing process fit analysis to complete feasibility, conceptual, and preliminary design studies including developing scope, budget, and schedule for existing or new facilities
Strong application and teaching skills relative to data analysis including experience with JMP or similar software and applicable tools/methodologies: Design of Experiments, Statistical Process Control, Measurement System Analysis, Stability Analysis, Regression Analysis, etc.