Principal BioProcess Engineer
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 Principal BioProcess Engineer is an industry recognized 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:
- Act as the 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
- Lead 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
- Coordinate with teams in the preparation and conduct of study protocols, data analysis, reports and standard operating procedures (SOPs) that support development and manufacturing activities
- Lead teams developing the drug product process for products within the MTEM pipeline
- Prioritize across multiple projects.
- Provide SME troubleshooting expertise/support on projects or significant process related technical issues in upstream, downstream, fill/finish, and various analytical methods
- Lead technically for quality system responsibilities: process-related investigations; product impact assessments, change control assessments, CAPA assessments, etc.
- Serve as lead study owner for 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
- Coordinate with management staff on projects and initiatives with timelines, budgets, resources, and in accordance with regulatory, quality, and safety requirement
- Bachelors' Degree in Chemical/Biochemical Engineering, with a minimum 10 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 with leading 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 leading 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.
- Demonstrated leadership of technical teams and effective cross-functional communication.
- Skill in working on problems of complex scope where analysis of situations or data involves multiple competing factors
- Skill in listening to and understanding others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentation
- Interacts well with diverse groups and maintains strong working relationships with internal and external collaborators
- Possesses interpersonal skills to negotiate and reconcile differences
- Ability to exercise judgment and advises management as to the appropriate actions.
- Ability to work well with other technical staffs and scientist/engineers in a collaborative, fast-paced goal-driven environment
- Fluency in English is required
This position currently has no supervisory responsibilities. This position reports to Sr. Director, Process Sciences.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
Molecular Templates Inc https://mtem.isolvedhire.com