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Product Quality Lead

Employer
Takeda
Location
Lexington, Massachusetts
Start date
Feb 4, 2025
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Job Details

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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 Shire Human Genetic Therapies Inc. for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Product Quality Lead

POSITION DESCRIPTION:Shire Human Genetic Therapies Inc. is seeking a Product Quality Lead with the following duties: Be responsible for the strategic quality oversight of the company’s global complex commercial Biologics product portfolio for both commercial products and products at late-stage development; Be accountable to supporting long-term quality objectives for the global product portfolio, and for supporting ongoing continuous improvement; Be accountable for consulting and informing all relevant quality stakeholders to ensure aligned, strategic decision making and support the Incident Escalation process; Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers; Support quality review of regulatory submissions (i.e., filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the operational strategy, GMP requirements and are verified for accuracy and data integrity; Support business growth in product launch, due diligence, divestment and integration activities and works in partnership with relevant stakeholders to influence quality strategy; Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase; Provide Quality input to establish preferred Supply Chain architecture; In collaboration with relevant stakeholder’s, develops recommendations which improve product, process and supply chain architecture strategies and establishes key product launch considerations, attributes and profiles for those products nearing commercialization.

REQUIREMENTS: Bachelor’s degree in Chemical Engineering, Biochemistry, or related field plus 10 years of related experience. Prior experience must include: Execution of downstream processing/protein purification of large molecules; Design process characterization studies applying QbD principles for drug development; Technology Transfer of drug substance manufacturing process; Mastered knowledge of quality systems and global regulatory submission; Performed different analytical methods to determine and understand protein characteristics; Developed drug substance process development and manufacturing.

Full time. $141,100 - $255,600 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0143292. 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.

LocationsLexington, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Company

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.

 

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future

For more information, visit https://jobs.takeda.com/

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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