Shire Regenerative Medicine's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
The Associate Director of Manufacturing SHORE has direct responsibility for providing manufacturing expertise and experience to the design of the SHORE cGMP manufacturing facility for tissue engineered products. Efforts will focus on design, implementation, start-up and validation of areas and systems to support and execute cell culture processes to produce Drug substance and the packaging of those to create drug product. Incumbent is expected to work independently and use judgment in carrying out functions. Knowledge and experience working under GMPs and validation requirements is essential. This position will be the liaison between the SHORE Team and current North Torrey Pines Operations group. The individual will provide the manufacturing perspective on all selections and processes.
This individual is expected to interact with Process and I&C Engineering, Process Development / Research groups, Contractors, Architects and contract Engineers on the design, specification, and construction of new facilities and timelines.
Responsibilities
Provide the Manufacturing Strategic Plan for the start up, staffing, validation and qualification of ABH’s new Manufacturing facility
Work with NTP Manufacturing, QA, QC, MTS and PD to develop and define a technology transfer and qualification plan for transfer of current Manufacturing process to the new facility.
Prepare docs /OpEx
Support work of the Engineering group, which includes performing equipment and system studies, research/evaluate process equipment components, and review/modify equipment operation as a result of troubleshooting.
Review design drawings, and assist with room layouts and finish selection.
Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and systems located in the new manufacturing facility.
Assist with start-up and troubleshooting of process equipment and critical clean utility systems.
Manage manufacturing representation at factory inspections of vendor-supplied equipment, to ensure that construction and performance meets specifications.
Education and Experience Requirements
B.S. degree in Science or Engineering with at least 10 years relevant biopharmaceutical and/or biologics manufacturing experience
In-depth technical knowledge of biotechnology plant operations
Thorough knowledge of medical device/biopharmaceutical manufacturing and process equipment, especially those related to sanitary and sterile operations.
Validation experience related to manufacturing systems, including requirements for documentation and testing.
Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and experience in equipment start-up and validation.
Ability to review engineering drawings and specifications.
Experience from a background of manufacturing, design or construction.
Good understanding of clean room or classified area design/requirements.
Good organization and time utilization skills.
Good interpersonal skills with an ability to interact well with a variety of people, craft skills and educational levels.
Good communication skills, written and verbal.
Previous supervision of manufacturing functions desired. Must be able to inspire and motivate group through leadership and implementation of effective management tools
Must understand the needs of key collaborators and customers, and interact effectively intra- and interdepartmentally to achieve alignment and consensus.
Must possess excellent management and presentation skills
Assure proper communication to Management with ability to judge when to escalate
Assure integration with site strategic plans for Cell culture at Shire RM
In addition to routine interaction with line management, key collaborations for this position involve the following:
Process Engineering
Validation
Quality Assurance
Facilities/Engineering
Materials Management
Supply Chain Planning
Leadership DNA Capabilities:
Accountability & Ownership
Inspiring & Motivating Others
Delivering Excellence
Serving Customers
Developing Organizational Capability
Shire is an Equal Opportunity and Affirmative Action Employer
Shire - 30+ days ago
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