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Associate Director - Manufacturing Sciences (Downstream) at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

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Job Description

Primary Duties

This individual will have the following responsibilities in the Manufacturing Sciences – Commercial Manufacturing Support Laboratory group:


  • Manage a team responsible for laboratory and technical support of commercial purification processes


  • Provide technical and operational oversight of experimental activities aimed at improving robustness, capacity, and productivity of commercial downstream processes


  • Provide technical expertise for troubleshooting of process discrepancies and product trends


  • Write and review study proposals, development reports, and regulatory documents



  • Identify and implement improvements in lab operations and equipment




​Education and Experience

Minimum Requirements:


  • A PhD in Chemical Engineering or related discipline with 6 years relevant experience; or


  • A MS in Chemical Engineering or related disciplines with 10 years of relevant experience; or


  • A BS in Chemical Engineering or related disciplines with 12 years of relevant experience.


Preferred:


  • Hands-on experience in lab scale protein purification


  • Experience with tech transfer and/or GMP manufacturing support


  • Experience with regulatory inspections, filings, and query responses


Key Skills, Abilities, and Competencies


  • Ability to develop staff, both technically and professionally


  • Be able to influence, motivate, and drive technical rigor when leading and participating on cross-functional teams.


  • Understand protein purification unit operations


  • Understand data analysis and statistically driven experimental design (DoE).


Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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