Senior Staff Engineer CMC, Downstream

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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: Lexington, MA

POSITION: Senior Staff Engineer CMC, Downstream

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Senior Staff Engineer CMC, Downstream with the following duties: Lead and perform non-GMP purification campaigns (pilot scale) to support new product development, material supply needs, and demonstration runs for multiple programs spanning all phases of biopharmaceutical development; Work cross-functionally and support global process development, manufacturing sciences, or tech transfer groups to troubleshoot problems, support large-scale studies and tech transfers, and support project goals; Analyze and compare analytical assay results including but not limited to UV-Vis, titer, SEC, CE-SDS, Glycan mapping, icIEF, HCP, DNA, rProA and endotoxin assays;  Record, trend, interpret, and present data independently at departmental and project meetings; Author documents such as paper batch records, electronic batch records (PAS-X), reports, protocols, internal/external presentations, and publications; Manage and supervise downstream team responsible for purification of proteins using various unit operations including depth filtration, chromatography, TFF, viral inactivation and viral filtration; Mentor junior team members in developing required skillsets; Write and review methods/ programs to run various unit operations using variety of equipment- AKTA (Unicorn), BioSMB, Pendotech (TFF Control System Software), Cytiva/ Pall UFDF skid; Identify and evaluate novel large-scale technologies that meet a generic platform across multiple processes. Up to 40% remote work allowed. Up to 5% travel required.

REQUIREMENTS: Master’s degree in Chemical Engineering, Biotechnology, Chemistry, Biology, Pharmacy, Engineering or related pharmaceutical science plus 9 years of related experience, OR, Bachelor’s degree in Chemical Engineering, Biotechnology, Chemistry, Biology, Pharmacy, Engineering or related pharmaceutical science plus 11 years of related experience. Prior experience must include: Design and execute purification process for the production of various biological modalities using extensive knowledge of various downstream unit operations such as chromatography (AEX, CEX, SEC, affinity and mixed mode chromatography), filtration (TFF, depth-filtration) and viral inactivation (VIN); Write and review methods in Unicorn software for the implementation of chromatographic steps, column qualification and tangential flow filtration; Compare and analyze results using the software; Analyze the quality of final DS and intermediates using various analytical assays such as AC-HPLC, SEC-HPLC, CE-SDS, UV spectrophotometer, Endotoxin and HCP testing; Work with cross functional team of research and PD project team leaders to contribute to the overall project strategy by leading production sub teams, coordinating cloning expression, purification and characterization of materials; Present production data, risk, and effort assessments; Provide input to milestone meetings and CMC sub team meetings; Evaluate and implement new tools and technologies such as Genedata, Gyro HCP assay, mixed mode resins and Levitronix; Work on extensive documentation including Batch record, SOP (Standard Operating Procedures), ELN (Electronic Lab Notebooks) and report writing; Mentor/ supervise junior team members.

Full time. $133,000 - $228,000 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0144981. 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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