Job Description
The Manager for Manufacturing Technical Operations (MTO) is responsible for the leadership of the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Boston Seaport location.
The Manager is responsible for the immediate triage, investigation, cross-functional collaboration, of manufacturing and cross functional deviations.
The Manager will be pivotal for maintaining quality event management and inspection readiness. This role aims to support our growing team in conducting root cause analyses, driving impact and risk assessments and formulating corrective and preventive actions (CAPAs) throughout VCGT.
This role is an on-site position in our Boston location in Seaport with occasional travel to Cambridge required.
The Manager will work one of the following shifts :
- Sunday Wednesday 1st shift (9 : 00 am - 7 : 30 pm)
- Thursday Saturday 1st shift (9 : 00 am - 7 : 30 pm)
KEY RESPONSIBILITIES :
- Lead, write and review deviations and investigations for Drug Substance / Drug Product Manufacturing, Facilities, Supply Chain and Material Operations.
- Manage team of approximately 5 extended workforce members
- Lead cross functional investigations to determine root cause for deviations and analytical investigations.
- Identify and collaborate with SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, and develop appropriate CAPAs.
- Own and drive deviations, CAPA, Analytical Investigations (AI) and change control records in electronic Quality Management System (eQMS).
Ensure all timelines and due dates are achieved.
- Lead cross functional meetings and regularly update stakeholders on the status of ongoing investigations, ensuring transparent communication and timely resolution.
- Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.
- Collaborates with subject matter experts to perform risk-based impact assessments.
- Provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.
- Demonstrate the Vertex behaviors : Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results;
and Promote Enterprise Thinking.
Other duties and projects as assigned to meet departmental requirements.
MINIMUM QUALIFICATIONS :
- 4+ years progressive experience in pharmaceutical development and manufacturing.
- 2+ years of experience mentoring and managing staff.
- Understanding of the science and technology of cell and gene therapies.
- Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
- Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.
- Experienced with technical writing and performing event investigations in a GMP-compliant environment.
Manager, Technical Development Operations
The Lab Operations and Materials team seeks a candidate who will support management of day-to-day operations involved in running labs and will serve as the primary liaison between labs, lab associates and various external partners. Act as liaison between laboratory, lab staff and collaborate with th...
Operations Manager - Electronics Manufacturing - Danvers, Ma
The Operations Manager will report directly into the VP of Operations and be responsible for:. Minimum of 5-7 years of experience in manufacturing operations management, preferably in the telecommunications industry. My client is a leading innovator in the telecommunications manufacturing industry, ...
Pharma Life Sciences, (manufacturing & Quality) Technical Delivery Sr. Manager
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. Advise stakeholders on relevant technical issues for their business area. Shaping and Delivering technology solutions with a focus on manufacturing and quality;...
Manufacturing Technical Operations Manager
The Manager for Manufacturing Technical Operations (MTO) is responsible for the leadership of the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Boston Seaport location. The Manager is responsible for the immediate triage, investigation, cross-funct...
Sr. Manager, Technical Partner Operations
Manager for Technical Partner Operations to join Bevi’s Customer Care Operations Team. This role is critical in ensuring key Partner accounts have outstanding service via proactive outreach and ensure Technical Partner Managers are available for technical support inquiries and escalations. Lead, coa...
Manufacturing - Maintenance & Reliability - Sr. Manager - Operations Consulting
SummaryA career in Product Development and Manufacturing, within Operations Consulting, will provide you with the opportunity to help organizations uncover enterprise insights and drive business results using smarter data analytics. Manufacturing Strategy & Operations;. Our Product Development & Man...
ERP Business Systems Analyst, Amazon Robotics Manufacturing & Technical Operations (RMTO)
The Business Operations team (Biz Ops) for Robotics Manufacturing Technical Operations (RMTO) works across the Fulfillment Technologies & Robotics (FTR) department to enable manufacturing scalability and adaptability to best serve the Amazon Operations Network. This role will report to the Robotics ...
Operations & Technology Transformation Manager, Guidewire PolicyCenter Configuration Technical Lead
Operations & Technology Transformation Manager, Guidewire PolicyCenter Configuration Technical Lead. As an OTT Insurance Transformation Manager, you will bring considerable technical expertise to deliver effective solutions to clients. Operations and Technology Transformation delivers market lea...
Senior Manager, Manufacturing Technical Services - 2nd shift
Manager, Manufacturing Technical Operations (MTO) is responsible for operational support and compliance MTO teams supporting Cell and Gene Therapy (VGT) manufacturing operations for cell manufacturing in Boston and Cambridge. This role will require some regional travel to support our Cambridge manuf...
Technical Program Manager, Engineering Operations
We are seeking an experienced Technical Program Manager of Engineering Operations to join our team. Work closely with engineering managers and leads, product managers/owners, to ensure rapid execution and on time, high quality delivery for the system. You will utilize your strong technical expertise...