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Sr. Technical Specialist, Drug Product Commercial Manufacturing (Process Engineering)

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

The Sr. Technical Specialist, Drug Product Commercial Manufacturing (Process Engineering) is an exciting opportunity to join Vertexs growing Technical Operations team and facilitate rapid commercialization of new products utilizing continuous manufacturing technology while working with first-in-class commercial operations and external suppliers in an industry-leading Quality by Design (QbD) environment. Vertex Pharmaceuticals currently has four significant commercial products in addition to a very robust pipeline with multiple new molecules in various stages of clinical development. The Senior Technical Specialist is a key technical resource, utilizing their technical expertise to resolve issues and continuously improve the manufacturing process. The successful candidate will have the opportunity to add significant value by advancing further understanding around continuous manufacturing process and automation. More specifically, the candidate will:

* Develop fundamental understanding of the working principles of various interconnected powder processing unit operations, powder flow behavior and the underlying control system logic to help troubleshoot and advance CM technology in a highly regulated manufacturing environment. * Direct due diligence and technology transfer activities associated with enabling new continuous and traditional manufacturing capabilities and capacity at external suppliers. * In this role, the candidate will work collaboratively heavily with Subject Matter Experts (SME) both at Vertex and external manufacturing sites, and has the ability to understand and communicate outcomes to effectively address project needs.

In order to succeed in this role, the candidate must be an excellent collaborator and have experience in a cGMP pharmaceutical drug product manufacturing environment. The successful candidate will have a background in solid oral dosage form manufacturing and its related processes and unit operations, including familiarity with PAT (inline product quality testing) strategies, as well as internal and external technology transfer.

Minimum Qualifications:

* Degree in an engineering discipline: BS and 4+ years, MS 2+ years or PhD with 0+ years of relevant work experience * Experience/working knowledge in solids flow modeling and powder processing equipment design and controls. * Process Development experience in solid oral dosage forms and a sound understanding of the pharmaceutical development process * Ability to clearly and effectively summarize results and implications of work in scientific reports * Ability to multitask to effectively manage multiple activities and projects * Must be a committed team player and collaborator * Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience * Ability to travel up to approximately 20 30%

Preferred Qualifications:

* Automation and/or PLC programming experience * Solids flow modeling

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Sr. Technical Specialist, Drug Product Commercial Manufacturing (Process Engineering), IT / Software / Systems , Boston, Massachusetts

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