Engineer IV

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: 300 Shire Way, Lexington, MA 02421

POSITION: Engineer IV

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking an Engineer IV with the following duties: Independently plan and execute most purification unit operation, development, characterization and optimization experiments within expertise; assist in preparing technology transfer documentation; may provide support/trouble shooting during technology transfer or manufacturing; independently interpret and communicate results (e.g., to technical and/or CMC project teams); lead technology transfer activities (from bench to pilot and manufacturing scales) and compile vendor data for feedback for presentation to process engineers or vendor. Areas of focus include but are not limited to chromatography, filtration, diafiltration, design of experiments (DOE), statistical modelling, risk and root-cause assessment, process scale-up and transfer, writing CMC regulatory documents as necessary; contribute significantly to multiple projects within area of expertise and coordinate relevant project management. As necessary, anticipate and troubleshoot issues; be responsible to propose and implement resolutions; review, interpret data and communicate results to impacted line functions; be responsible for keeping abreast of area related technologies/methodologies within scope of position; be responsible for writing technical reports for functional area; engage in necessary communication between stakeholders (i.e. technical, CMC sub-team, functional team, vendors, and other subject matter experts); provide guidance and direction to colleagues as necessary for technical projects; participate in innovation projects (i.e. continuous processing, mechanistic modelling); have experience in presenting publicly (i.e. oral presentations, posters, publications); Serve as a chemical engineer for biotherapeutics process development with a focus on protein (including monoclonal antibodies, fusion proteins, enzymes, protein-drug-conjugate molecules) purification, utilizing techniques that include affinity chromatography, ion-exchange chromatography, hydrophobic interaction chromatography, ultrafiltration/diafiltration, depth filtration and membrane filtration; Independently plan and execute purification unit operation, development, characterization, and optimization experiments within expertise; Operate low pressure chromatography systems, automated high throughput robotics systems, and other various specialized equipment for simulated moving bed chromatography, ultrafiltration/diafiltration, depth filtration, nanofiltration, and membrane chromatography; Assist in preparing technology transfer documentation; Provide support and troubleshooting during technology transfer or manufacturing; Independently interpret and communicate results to technical and CMC project teams; Lead technology transfer activities from bench to pilot and manufacturing scales and compile vendor data for feedback for presentation to process engineers or vendor; Perform process design and optimization utilizing design of experiments (DOE), statistical modelling, mechanistic modelling, machine learning applications, risk and root-cause assessment, process scale-up and transfer, and writing CMC regulatory documents as necessary; Contribute to multiple projects within area of expertise and coordinate relevant project management; Anticipate and troubleshoot issues as required; Propose and implement resolutions to process challenges; Review, interpret data, and communicate results to impacted line functions; Responsible for keeping abreast of area related technologies and methodologies within scope of position; Responsible for writing technical reports for functional area; Engage in necessary communication between stakeholders (including technical, CMC sub-team, functional team, vendors, and other subject matter experts). Up to 10% domestic and international travel required. Up to 20% remote work allowed.

REQUIREMENTS: Master’s degree in Bioengineer, Biology, Chemical Engineer, Chemistry or related field plus 3 years of related experience. Prior experience must include perform purification process, including experimental planning, sample handling, method creation; conduct tech transfer for manufacturing sites; analyze experimental data using JMP; write technical documents; monitor GMP manufacturing and related in-process controls; implement new technology associated with continuous processing; develop and transfer methods (purification process & analytical).

Full time. $122,600 - $165,600 per year.  Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0134375  EOE.

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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