Head of Manufacturing
4 weeks ago
CARsgen is looking for a senior Manager of CAR-T cell therapy manufacturing. The role will report to the head of Technical Operations and is responsible for managing the daily clinical manufacturing activities of CT053, CT041 and other CAR-T cell products at the US Durham, NC facility. The position will also supervise the manufacturing staff, ensure GMP trainings and compliance, plan the productions, and champion various initiatives aimed at improving quality and efficiency. This position will also play a key role in tech transfers. This person is a key member of the site leadership and will serve as an operating steward for the US site. Duties and Responsibilities: Lead manufacturing team in planning and executing CAR-T cell therapy productions to meet clinical needs. Collaborate closely with MST and other functions to execute tech transfers to RTP site. Manage cleaning staff/contractors to ensure manufacturing areas are cleaned per established SOPs. Build effective cross-functional collaborations with Quality, Supply Chain, MS&T, EHS, and Facilities. Ensure a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements. Set goals, tracking and KPIs, and drive continuous improvement through operational excellence, technical advancement, and lean manufacturing initiatives. Establish a manufacturing management system that is technically sound, promotes efficient operations, and complies with cGMP requirements. Ensure schedules of the people, facility, equipment, materials, and documents are well organized to support the expected capacity for CAR-T manufacture. Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients. Lead major investigations related to manufacturing. Ensure on-time closure of deviations, CAPAs, and change controls. Shape and develop a fit-for-purpose department organization and an inclusive high-performing business team, continuously improving team efficiency through effective management methods, such as fair and objective performance evaluation of team members and effective internal communication. Develop and implement internal training programs for the manufacturing team to improve productivity and ensure compliance. Establish management policies, shift structure, and career ladders for Associates and supervisors. Draft, review, and approve various GMP documents, including standard operating procedures, batch records, material specifications, and validation protocols/reports. Up to 5% travel may be required. Qualifications and Experience: Bachelor’s or advanced degree in relevant science or engineering discipline. 7+ years’ experience with cGMP biologics manufacturing and/or cell therapy operations including at least 3 years managerial experience as manufacturing head. Experience in supporting commercial licensure (BLA) of CAR T or other cell therapy products is preferred. Knowledge of Lean Manufacturing and implementation is required. In-depth knowledge and experience with CAR T manufacturing processes or other cell therapy processes, which includes cell culture, cryopreservation, filling, and aseptic processing. Knowledge of the cGMP/FDA regulated industry, including direct experience with ex-US Health Authorities (EMA, Health Canada, PDMA) and inspections, preferably for commercial CAR T products. Ability to work effectively in a cross-functional setting to deliver results and meet business objectives. Experience with reviewing and approving SOPs, Batch Records, Change Controls, deviations, and CAPAs. Strong background in training and GMP compliance. Background to include an understanding of biology, chemistry, medical, or clinical practices. Previous experience managing, coaching, and providing direction to manufacturing and technical staff in a commercial biopharmaceutical manufacturing setting. #J-18808-Ljbffr
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Head of Strategic Partnerships
2 weeks ago
Durham, North Carolina, United States LCI Full timePosition Title: Head of Strategic PartnershipsJob Overview:Department: Business DevelopmentReporting To: VP, Business DevelopmentPurpose Statement:The Head of Strategic Partnerships will spearhead LCI's Business Development strategy, focusing on collaborating with clients and stakeholders to uncover innovative business avenues that lead to the creation of...
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Manufacturing Associate I
3 weeks ago
Durham, United States Corning Full timeRequisition Number: 63444 Corning is vital to progress – in the industries we help shape and in the world we share. We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and...
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Executive Director, Manufacturing
1 month ago
Durham, United States HUMACYTE GLOBAL INC Full timeJob DescriptionJob DescriptionJOB TITLE: Executive Director, Manufacturing & Supply Chain (Consumables & Raw Materials Manufacturing )DEPARTMENT: Site OperationsLOCATION: Durham, NC, Onsite/Not RemoteCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues,...
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Manufacturing Associate I
3 months ago
Durham, United States Corning Full timeRequisition Number: 63444 Corning is vital to progress – in the industries we help shape and in the world we share. We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and...
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Manufacturing Associate I
3 months ago
Durham, United States Corning Full timeRequisition Number: 63444 Corning is vital to progress – in the industries we help shape and in the world we share. We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world...
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Durham, North Carolina, United States GSK Full timeSite Name: USA - North Carolina - DurhamPosted Date: Jul 9 2024ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and...
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Senior Operations Manager
2 weeks ago
Durham, North Carolina, United States VALID8 Financial Full timeVALID8 Financial is seeking a Senior Operations Manager to oversee CAR-T cell therapy manufacturing processes. This pivotal role will report directly to the head of Technical Operations and will be responsible for managing the daily clinical manufacturing activities of CAR-T cell products. The successful candidate will lead the manufacturing team, ensuring...
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Head of Clinical Standards
2 weeks ago
Durham, North Carolina, United States American Society of Echocardiography Full timeThe American Society of Echocardiography (ASE) is a nonprofit medical organization dedicated to enhancing cardiovascular ultrasound to improve patient outcomes. ASE is a vibrant, collaborative organization that provides competitive compensation, a comprehensive benefits package, generous paid time off, and a flexible hybrid work environment. ASE is looking...
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Head of Quality Control
3 weeks ago
Durham, United States CARsgen Therapeutics Full timeS/he is responsible for managing all QC functions, working with cross-departmental leadership to deliver high quality results across all laboratory functions. Build and develop a professional and efficient QC team to establish and maintain a quality system within QC functions to ensure compliance to latest regulatory and health authorities...
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Head of Quality Control
3 weeks ago
Durham, United States CARsgen Therapeutics Full timeS/he is responsible for managing all QC functions, working with cross-departmental leadership to deliver high quality results across all laboratory functions. Build and develop a professional and efficient QC team to establish and maintain a quality system within QC functions to ensure compliance to latest regulatory and health authorities...
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Instrumentation and Controls Engineer
1 month ago
Durham, United States Hays Full timeYour Impact:Collaborate with colleagues across different manufacturing facilities and the global engineering team to set the gold standard for control system maintenance and operation.Dive into programming intricacies, enhancing existing systems to improve sequencing, alarms, and troubleshooting capabilities within PLCs, HMIs, and automated processes.Work...
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Instrumentation and Controls Engineer
1 month ago
Durham, United States Hays Full timeYour Impact:Collaborate with colleagues across different manufacturing facilities and the global engineering team to set the gold standard for control system maintenance and operation.Dive into programming intricacies, enhancing existing systems to improve sequencing, alarms, and troubleshooting capabilities within PLCs, HMIs, and automated processes.Work...
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Production Associate
6 days ago
Durham, North Carolina, United States Corning Full timeJob Summary:Corning is seeking a skilled Manufacturing Associate to join our team in the production of fluid handling and cell culture products. As a key member of our manufacturing team, you will be responsible for ensuring the safe and efficient manufacture of our products.Key Responsibilities:Operate and maintain packout equipment, rotating operation...
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Quality Control Specialist
19 hours ago
Durham, North Carolina, United States Corning Incorporated Full timeJob SummaryCorning Incorporated is seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products by performing in-process and final inspections, accepting or rejecting products based on inspection criteria, and reporting issues to supervisors.Key...
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Quality Control Associate I
3 weeks ago
Durham, United States Corning Full timeRequisition Number: 64307Corning is vital to progress - in the industries we help shape and in the world we share.We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and...
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Full Time Flexible Sitter in Durham
4 weeks ago
Durham, United States Jovie of Cary Full time $15 - $18Job DescriptionJob DescriptionFull Time Flexible SitterWhat we need: Sitter will work with families for a guaranteed 30-40 hours a week. Sitter would open up availability 7a-7p Monday-Friday or any weekdays in order to receive first choice and as many hours as they would like. Who we are: Hello, we’re Jovie of Cary and we offer the nation’s most...
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Senior Financial Analyst
2 weeks ago
Durham, North Carolina, United States City of Durham Full timeJoin the City of Durham as a Senior Financial AnalystSalary Range: $61,000 - $78,214.00Work Hours: 8:00 AM - 4:30 PMThe City of Durham's Water Management Department is home to over 370 skilled and dedicated professionals committed to ensuring the delivery of safe drinking water and effective wastewater management throughout the community.Our team is engaged...
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Full Time Flexible Sitter in Durham
3 months ago
Durham, United States Jovie of Cary Full timeJob DescriptionJob DescriptionFull Time Flexible SitterWhat we need: Sitter will work with families for a guaranteed 30-40 hours a week. Sitter would open up availability 7a-7p Monday-Friday or any weekdays in order to receive first choice and as many hours as they would like. Who we are: Hello, we’re Jovie of Cary and we offer the nation’s most...
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Video Production Specialist
22 hours ago
Durham, New Hampshire, United States University System Of New Hampshire Full timeJob SummaryThe University System of New Hampshire is seeking a highly skilled Video Coordinator to oversee all video and technology operations of the UNH football program. This is a full-time position that requires a strong background in video production, technology, and project management.Key ResponsibilitiesFilm all practices and games, ensuring...
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Quality Control Associate I
2 months ago
Durham, North Carolina, United States Corning Full timeRequisition Number: 64307 Corning is vital to progress – in the industries we help shape and in the world we share. We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and...