Thermo Fisher Scientific Manufacturing Specialist - Operations Product Leader (OPL) in Lexington, Massachusetts
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. The position will reside in Lexington, MA.
How will you make an impact?
As part of Lexington’s Gene Therapy Site’s manufacturing organization, the Operations Product Leader (OPL) is responsible for leading a product focused cross functional production flow / value stream team alongside members of the Manufacturing, Engineering, Manufacturing Sciences Technology (MST), Quality Control and Quality Assurance organizations. The team’s mission is to deliver a consistent and reliable supply of quality released commercial viral vector drug substance and/or drug product to meet client’s needs over the product lifecycle. Partnering with production management, the OPL is responsible for indirect operational / production suite support activities including production scheduling, deviation investigations, change control management, document revision management, and training all according to current good manufacturing practices (cGMP). He/she provides the cross functional leadership, operations acumen, and results focus to reliably meet and/or exceed product supply targets while achieving high levels of quality. This position requires an individual capable of partnering across the site to implement robust business processes to support the successful planning, production, testing, and release of product in a fast-paced production environment.
What will you do?
Lead operational / production readiness for late clinical stage and commercial manufacturing of new products ensuring robust implementation of new production capabilities that reliably and sustainably meet and/or exceed operational, quality, and cost targets.
Manufacturing lead for New Product Introduction and technical transfer team, communicating with client throughout product lifecycle.
Provide daily management oversight of product’s production flow / value stream ensuring end to end internal supply chain delivers product on-time and in-full.
Establish key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
Proactively identify and escalate key risks and issues to manufacturing line and site leadership team. Organize and lead ad hoc cross functional teams to develop risk mitigation plans and/or manage complex operational issues.
Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
Ensure high levels of communication with team, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
Partner with technical leadership, program management and clients to implement product / process improvements; participates and/or may lead cross functional projects. Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
Engage in proactive relationships with client including acting as key client interface representing Brammer operational interests in both tactical and strategic meetings.
How will you get here?
Bachelor's degree and 5-7 years of related work experience or Master’s degree and 3-5 years of work experience preferred.
Experience leading cGMP operations teams or projects in fast paced production environment preferred.
Demonstrated ability to manage cross-functional teams and collaborate across the business.
Strong analytical and problem solving skills; great attention to detail and excellent decision making process.
Expertise in managing small and medium technical and/or capital projects.
Demonstrated ability to present ideas persuasively and negotiate effectively.
Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
Strong planning, organization and multitasking skills
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Ability to make decisions and work with minimal to moderate supervision.
Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.
Solid understanding of applicable regulatory requirements.
Gown aseptically and/or sterile gown as needed.
Write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.
The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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