Operations Manager
Description Position at The O'Connor Group Overview Our goal is to improve lives by restoring or replacing the function of damaged cells, tissues, and organs for patients.
ARMI BioFabUSA's mission is to develop a highly diverse, competitive, capable and innovative domestic cell, tissue and organ manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury; and to establish the trained and ready workforce essential for that ecosystem, centered in Manchester, NH with national impact.
The Impact That You Will Make The growth and development of our operational capabilities is critical to our success.
You and your team will support the development, optimization, and implementation of pre-GMP and GMP-stage manufacturing processes for cells, tissues, and organs.
In this role, you will interact directly with external partners, program management, technical operations, quality, and other stakeholders to enable the successful delivery of programs.
Reporting to the BioFabUSA's Chief Operating Officer, you will be responsible for implementing best practices for procurement, warehouse and materials management, process and equipment validation, and facilities support.
You will be responsible for building and growing a world-class operations team.
You will also have a leading role in transitioning our operations from a pre-GMP state to a full GMP environment and in starting up a new 100,000 sq.
ft.
GMP manufacturing facility.
Your Role Lead facility, equipment, EHS, and materials management functions to ensure the successful execution of programs Develop, coach, and mentor team members and establish best-in-class practices Support the implementation of enabling IT systems especially the manufacturing execution system (MES) implementation - provide on-going MES support Together with the Quality Assurance team, drive the internal process and equipment validation efforts for onsite equipment and manufacturing processes that support GMP or pre-GMP compliance In partnership with Program Management, implement a resource planning process to optimize the use of facility space, equipment, materials, and personnel for program execution With Program Management and Technical Operations, deliver technology transfer and daily operational support for process-specific operations Identify and lead continuous improvement initiatives that build standard work practices and develop systems to improve business operations Your Skills and Experiences Minimum of 5 years of relevant operations, supply chain, and facility management experience in the biopharmaceutical industry Team leadership experience in a GMP-certified, multi-product CDMO Strong materials management background with a working knowledge of budget management, procurement, and basic accounting principles Experience with implementing enabling information technology systems is highly desired:
electronic lab notebooks, laboratory information management systems, document management systems, procurement systems, manufacturing execution systems, manufacturing resource planning systems, and enterprise resource planning systems Direct involvement with Quality and other functions to attain and maintain GMP certification Knowledge and practical application of Lean manufacturing concepts Familiar with technology, material, and equipment transfer and qualification best practices Demonstrated track record of coaching and developing high-performing teams Proven ability of leading teams through change successfully and adjusting plans, as needed, to achieve strategic objectives Exceptional problem-solving and organizational skills Strong verbal and written technical communication skills with both technical and non-technical audiences Advanced Regenerative Manufacturing Institute - Manufacturing the Future of Biofabrication1 Technology Center 400 Commercial St.
Manchester, NH 03101 www.
armiusa.
org This document is intended to be a confidential communication.
Any dissemination, distribution or copying of this communication is strictly prohibited.
Recommended Skills Basic Accounting Principles Biopharmaceuticals Business Process Improvement Coaching And Mentoring Coordinating Document Management Systems Estimated Salary: $20 to $28 per hour based on qualifications.
ARMI BioFabUSA's mission is to develop a highly diverse, competitive, capable and innovative domestic cell, tissue and organ manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury; and to establish the trained and ready workforce essential for that ecosystem, centered in Manchester, NH with national impact.
The Impact That You Will Make The growth and development of our operational capabilities is critical to our success.
You and your team will support the development, optimization, and implementation of pre-GMP and GMP-stage manufacturing processes for cells, tissues, and organs.
In this role, you will interact directly with external partners, program management, technical operations, quality, and other stakeholders to enable the successful delivery of programs.
Reporting to the BioFabUSA's Chief Operating Officer, you will be responsible for implementing best practices for procurement, warehouse and materials management, process and equipment validation, and facilities support.
You will be responsible for building and growing a world-class operations team.
You will also have a leading role in transitioning our operations from a pre-GMP state to a full GMP environment and in starting up a new 100,000 sq.
ft.
GMP manufacturing facility.
Your Role Lead facility, equipment, EHS, and materials management functions to ensure the successful execution of programs Develop, coach, and mentor team members and establish best-in-class practices Support the implementation of enabling IT systems especially the manufacturing execution system (MES) implementation - provide on-going MES support Together with the Quality Assurance team, drive the internal process and equipment validation efforts for onsite equipment and manufacturing processes that support GMP or pre-GMP compliance In partnership with Program Management, implement a resource planning process to optimize the use of facility space, equipment, materials, and personnel for program execution With Program Management and Technical Operations, deliver technology transfer and daily operational support for process-specific operations Identify and lead continuous improvement initiatives that build standard work practices and develop systems to improve business operations Your Skills and Experiences Minimum of 5 years of relevant operations, supply chain, and facility management experience in the biopharmaceutical industry Team leadership experience in a GMP-certified, multi-product CDMO Strong materials management background with a working knowledge of budget management, procurement, and basic accounting principles Experience with implementing enabling information technology systems is highly desired:
electronic lab notebooks, laboratory information management systems, document management systems, procurement systems, manufacturing execution systems, manufacturing resource planning systems, and enterprise resource planning systems Direct involvement with Quality and other functions to attain and maintain GMP certification Knowledge and practical application of Lean manufacturing concepts Familiar with technology, material, and equipment transfer and qualification best practices Demonstrated track record of coaching and developing high-performing teams Proven ability of leading teams through change successfully and adjusting plans, as needed, to achieve strategic objectives Exceptional problem-solving and organizational skills Strong verbal and written technical communication skills with both technical and non-technical audiences Advanced Regenerative Manufacturing Institute - Manufacturing the Future of Biofabrication1 Technology Center 400 Commercial St.
Manchester, NH 03101 www.
armiusa.
org This document is intended to be a confidential communication.
Any dissemination, distribution or copying of this communication is strictly prohibited.
Recommended Skills Basic Accounting Principles Biopharmaceuticals Business Process Improvement Coaching And Mentoring Coordinating Document Management Systems Estimated Salary: $20 to $28 per hour based on qualifications.
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