Product Quality Lead

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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.

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