Manufacturing Associate I - Contingent

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. As a Contingent Manufacturing Associate I, you will be responsible for operating both automated and manual cell therapy equipment of varying complexity to support CAR-T, CAR-M, or CAR-NK manufacturing processes, following established standard operating procedures and company policies. You will conduct quality control analyses to support in-process batch production and detect any process deviations. This role involves handling leukapheresis-derived cellular materials; therefore, you will receive comprehensive training in hazardous material handling and emergency response procedures. As part of the manufacturing operations, you will be expected to demonstrate a strong understanding of procedures, techniques, tools, materials, and equipment used in the production process. Your role will involve team-based decision-making, with a focus on prioritizing workflows based on process requirements and available resources. You will follow standard operating procedures to carry out tasks that may vary in scope, complexity, and duration. Patients are counting on dedicated professionals like you—those who take pride in their work and strive for meaningful results. In this role, you'll play a vital part in ensuring life-changing therapies reach the patients who need them, exactly when they need t

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. The Senior Quality Assurance Associate supports the day-to-day early phase cell and gene therapy clinical GMP manufacturing operations via execution of all operational elements of the Quality Management System (QMS), including but not limited to the EDMS (electronic document management system) and training management system in support of gene and cell therapy manufacturing production. They will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, and the Laboratories to ensure cGMP compliance and establish a quality culture. This is a unique opportunity to help build and grow the Quality Assurance organization in a dynamic new environment. Experience with administrative access using Veeva as a document control and training management system preferred. Essential Duties and Responsibilities Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Essential Duties and Responsibilities Assist in executing QA responsibilities to support material and product release. Work with Quality team mem

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. Kincell is seeking a highly motivated Sr. Project Manager who will be a key contributor to a dynamic and collaborative Project & Program Management team. The senior project manager role is charged with delivering consistent project and program management on behalf of our customers, acting as their internal advocate within Kincell Bio, representing the voice of the customer, and ensuring effective cross-functional project and resource management. The senior project manager will have a strong background in biologic drug substance and/or drug product development, enabling them to credibly work with customers and department heads to drive programs through the critical path of process development and GMP manufacturing. The senior project manager will devise, integrate, and execute high-quality, cross-functional project plans that reflect the specific goals of each customer program. In collaboration with our customers, internal functional leaders, and scientific subject matter experts, the senior project manager will integrate scientific and business priorities to drive effective delivery of the program deliverables. The Client's senior project manager will be responsible for establishing effective teamwork, executing the program strategy, providing project leadership, and fa

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. Essential Duties and Responsibilities Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Perform environmental monitoring (air, surface, compressed gas, and personnel) of the cleanrooms and laboratory to support GMP manufacturing to include off-hours/weekend coverage as needed. Assist in maintaining microbiology and QC laboratories in a clean, orderly, compliant, and inspection-ready condition. Execute laboratory experiments and assays (osmolality, pH, endotoxin, sterility, plate reading, etc.). Perform data review and calculation verifications. Participate in laboratory investigations including deviations and out of specifications. Assist with laboratory equipment maintenance and calibration as needed. Assist with environmental monitoring and assay related investigations. Assist with qualification and validation of equipment, processes, and analytical methods, including protocol development and execution.Gai Ensure all activities are performed in accordance with company policies, procedures, SOPs, GMP requireme

Quality Engineer (Associate or Experienced) Company: The Boeing Company Boeing Defense, Space and Security (BDS) has an exciting opportunity for an Quality Engineer (Associate or Experienced) to join the Quality Fabrication team in Hazelwood, MO! This position supports the production line by leading root cause investigations and corrective actions for nonconformances (NCRs), performing line stock checks and data analytics to identify trends, and presenting to stakeholders. The role works closely with production, quality, supply chain and engineering to ensure timely containment and permanent corrective actions that reduce recurrence and improve process capability. Position Responsibilities: Researches contractual and Boeing Quality Management System requirements for applicability to specific proposals and program processes and documentation. Develops sections of quality metrics, design and production certification plans to ensure compliance with contractual, Company and regulatory requirements. Analyzes capability assessments to support supplier selection activities. Participates in various reviews to ensure quality attributes are incorporated into product designs. Performs data analysis to ensure manufacturing and test readiness. Provides material review dispositions for non-conformances. Analyzes non-conformance trends to evaluate effectiveness of corrective actions. Compiles performance reports and other statistical data to ensure specified processes capability levels are achieved. Works under general supervision. Basic Qualifications (Required Skills/Experience): Bachelor of Science from an accredited course of study

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Quality Technician POSITION SUMMARY: The Quality Technician will support manufacturing operations by ensuring in-process and finished medical devices meet established quality requirements, specifications, and regulatory standards. This role is responsible for identifying and documenting quality issues on the production floor, supporting investigations and root cause analysis, managing nonconforming materials, and collecting process and product data to drive continuous improvement. The technician works closely with Manufacturing, Quality Engineering, and cross-functional teams to ensure rapid response to quality concerns and compliance with applicable quality system regulations (e.g., FDA 21 CFR Part 820, ISO 13485). ROLES AND RESPONSIBILITIES Manufacturing Quality & Inspection Perform incoming, in-process, and final inspections of components, subassemblies, and medical devices in accordance with approved procedures, drawings, and sampling plans Ensure product compliance with specifications, GMP, and regulatory requirements Accurately document inspection and test results in device history records (DHRs) and other quality records Maintain traceability of materials and finished goods throughout production Nonconformance & Investigation Support Identify, document, and segregate nonconforming materials Support containment activities, including line clearance, product holds, and sorting/rework activities Assist in root cause investigations and corrective and preventive actions (CAPA) Collaborate with