AustinRecruiter Since 2001
the smart solution for Austin jobs

Principal BioProcess Engineer, Process Sciences

Company: Molecular Templates, Inc.
Location: Austin
Posted on: February 16, 2020

Job Description:

Company Description:Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at . Position Overview: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 Qualifications:
    • 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 Reporting Structure:This position currently has no supervisory responsibilities. This position reports to Sr. Director, Process Sciences.Molecular Templates Inc

Keywords: Molecular Templates, Inc., Austin , Principal BioProcess Engineer, Process Sciences, Engineering , Austin, Texas

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Engineering Jobs

Engineer I - Water/Wastewater Master Planning
Description: Company Overview: Freese and Nichols, Inc. is a professional consulting firm serving clients across the Southwest and Southeast United States. With sustainability in mind, Freese and Nichols plans, designs (more...)
Company: Freese and Nichols
Location: Austin
Posted on: 02/28/2020

Cybersecurity Staff-Lead Engineer Network and Perimeter Security
Description: POSITION PURPOSE br br Within the walls of The Home Depot, you ll find empowered associates who ideate, build, and implement innovative solutions for the world s largest home improvement retailer.The (more...)
Company: The Home Depot
Location: Leander
Posted on: 02/28/2020

SOC Verification Engineer
Description: Functional verification planning and test-plan developmentTestbench development using UVM/System
Company: Samaritan Technical Professionals
Location: Austin
Posted on: 02/28/2020

Sr. Network Engineer
Description: Who we are: br br We are a 25.5 billion wholesale bank that's been financing agriculture and rural America for nearly 100 years. Headquartered in Austin, Texas, we provide funding and services to (more...)
Company: Farm Credit Bank of Texas
Location: Austin
Posted on: 02/28/2020

SDET Automation Engineer
Description: POSITION: SDET Automation EngineerLOCATION: SAN ANTONIO TXDURATION: Long term contract 1 yr. Sr. Software Engineer in Test SDET Job Description Your future duties and responsibilities: As a Sr. Software (more...)
Company: Y & L Consulting Inc.
Location: San Antonio
Posted on: 02/28/2020

SOC Engineer with Security Orchestration (SOAR) Expertise - Austin, TX
Description: Stellar Consulting Solutions is a boutique business technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects (more...)
Company: Stellar Consulting Solutions
Location: Austin
Posted on: 02/28/2020

ETL Informatica Engineer/Administrator
Description: Job Description Job : 1048981The IPES team, is responsible for maintaining the multiple SOA, B2B and Cloud Integration Platforms, both Production and Non-Production. All Engineering and platform activities, (more...)
Company: Apex Systems, Inc
Location: Round Rock
Posted on: 02/28/2020

Lead Application Engineer #2783
Description: ANSYS, Inc. seeks Lead Application Engineer to work in Austin, TX.--ANSYS is the global leader in engineering simulation, helping the world's most innovative companies deliver radically better products (more...)
Company: ANSYS Inc
Location: Austin
Posted on: 02/28/2020

Application Engineer II #2784
Description: ANSYS, Inc. seeks Application Engineer II 2784 to work in Austin, TX.--ANSYS is the global leader in engineering simulation, helping the world's most innovative companies deliver radically better products (more...)
Company: Ansys, Inc.
Location: Austin
Posted on: 02/28/2020

Quality Engineer
Description: Surgery as it's meant to be seenClearCam is in the business of solving various problems presented in the minimally invasive operating room, with a pilot product launch in 2020 surrounding a novel technology (more...)
Company: ClearCam Inc.
Location: Austin
Posted on: 02/28/2020

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

Austin RSS job feeds