The Senior Scientist, Drug Product Process Development / Engineering will be a technical lead for clinical, biologics drug product process development / engineering and clinical drug product manufacturing support for Shire biologics products. The individual will develop biologic drug products across all phase of clinical development including early phase development, late phase development, scale-up, process optimization, and technology transfers. The individual will also support process validation in preparation for commercial launch.
The Senior Scientist will closely collaborate with cross-functional Process Development and CMC team members including formulation development, technical services, process validation, drug substance process development, analytical development, quality control, quality assurance, and supplier relationship and manufacturing leads.
The role and responsibilities are to
* Design drug product processes and establish processes at manufacturing sites. The Senior Scientist will lead and/or support cross-functional teams to define, coordinate, and track these activities.
* Execute drug product process development laboratory studies or manage studies performed by external partners. These studies will be used to evaluate drug product processes in scale-down models, characterize process performance or limits, and screen process parameters.
* Author development protocols and reports, prepare study materials, analyze data, and interpret results.
* Technical management of drug product manufacturing sites or CMOs including representing Shire as a technical lead / subject matter expert during manufacturing site team meetings.
* Identify solutions to technical challenges to enable on-time and on-budget delivery of clinical drug product. Communicate and defend rationale of proposed solutions to cross-functional teams as drug product process subject matter expert.
* Support drug product manufacturing deviation investigations, CAPAs, and change control management.
* Review and approval of manufacturing batch records, oversight of fill/finish operations, and supporting activities to enable clinical trial material supply
* Author sections of regulatory submissions for drug product process development and manufacturing
* 35% Manage drug product process development and engineering activities, including coordinate cross-functional support as needed, for clinical development and supply of clinical trial material
* 25% Execute, analyze, and interpret data for drug product process development laboratory studies including management of outsourced studies
* 25% Technical management of manufacturing site / CMO operations and manufacturing activities
* 10% Author and/or review drug product development protocols, reports, manufacturing batch records, and regulatory submissions
* 5% Travel required for person-in-plant oversight for critical drug product manufacturing
Education and Experience Requirements
* Minimum, BS degree in engineering, chemistry, biotechnology, or related science.
* Minimum, 5-8 years experience in biologics drug product development including drug product process and formulation development
* Aseptic fill/finish manufacturing experience and oversight of CMO operations
* Thorough knowledge of global GMP regulations and guidance
* Experience authoring technical protocols, reports, and CMC sections for regulatory submissions
* Experience within a project team (preferably involving external partners)
* Experience with quality exception management
KEY SKILLS AND COMPETENCIES
* Excellent communication, technical, organizational, interpersonal and leadership skills are required
* Must be a team player prepared to lead, work effectively and efficiently in a team-based environment
* Ability to work in a fast-paced environment and handle multiple projects simultaneously
* Critical evaluation of results and ability to defend strategic guidance to resolve technical issues
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