Specialist, Manufacturing

Kincell Bio, LLC•Durham, NC

8d•Onsite

About The Position

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at www.kincellbio.com. Kincell is seeking a highly motivated Manufacturing Specialist who will be a key contributor to a dynamic and collaborative Manufacturing team. As a Manufacturing Specialist, you will have the responsibility to ensure initiatives related to production readiness and compliance are optimized and executed appropriately in the areas of cGMP production. This position will directly support manufacturing for all production-related activities. You will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations. In addition, you will be operating automatic and manual cell therapy equipment with a variety of complexities in CAR-T, CAR-M, or CAR-NK processes in accordance with standard operating procedures and policies as needed. You will perform quality control analyses as required to complete in-process batches and identify variations. You will be trained in handling hazardous materials and emergency procedures since you will be handling leukapheresis cellular materials. As part of manufacturing operations, you will be a team member who is relied on to have a good understanding of procedures, techniques, tools materials, and equipment to help support cGMP activities at the Gianesville, FL site. Your work and decision-making will be team-based and will focus on the prioritization of workflows centered on the process and available resources. You will follow standard operating procedures to complete tasks which may vary in scope, complexity, and timing. Patients need colleagues like you who take pride in their work and look for successful outcomes. You will help ensure patients have the therapies they need when they need them. You will be operating cell therapy process equipment of varying complexity with different processes in accordance with standard operating procedures.

Requirements

B.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 5-7+ years of manufacturing experience.
Must have direct isolator or aseptic DP fill execution experience supporting sterility-critical operation.
Must be able to work onsite daily and be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.
Ability to work independently and stay on task in a fast-paced environment without direct supervision.
Experience supporting clinical manufacturing campaigns, regulatory inspections, and aseptic process validation in isolator-protected suites.
Knowledge of cell and gene-therapy workflows, isolator contamination-control strategy, metric systems, and process-measurement scale-ups.
Must have experience in drafting and reviewing technical documents with high technical writing skill.
Provides consistently prompt, efficient, dependable, and highly skilled services.
Understands, selects, and uses appropriate risk management and root cause analysis tools.
Takes initiative in making improvement suggestions to promote operational goals.
Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
Reflects solid understanding of strategies and goals and can take part in major parts of projects or provide expert service.
Recommends improvements to on-going processes and projects.
Facilitates designing processes with Quality built in from the beginning.
Identifies, and uses good judgement to handle out-of-compliance situations.
Good listening and communication skills.
Positive approach and highly collaborative persona.
Must be able to lift bags and/or containers of media of up to 40+lbs.
Manage personal time and professional development. Maintain accountability for your own outcomes and prioritized workflows.

Nice To Haves

M.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 3-5+ years of manufacturing experience
Have knowledge of cell and gene therapy processing, the metric system, and scales.
Excellent project management skills to ensure projects and goals are met in a timely manner.

Responsibilities

Subject Matter Expert in drug-product (DP) aseptic filling, sterility assurance, and isolator operations within a regulated cGMP biotechnology manufacturing environment.
Demonstrated hands-on proficiency with closed and open aseptic processing, including cell-therapy manipulation, cell culture, G-Rex expansion, formulation, and final DP fill execution.
In-depth operational knowledge of GMP isolators (ISO 5 unidirectional airflow, positive pressure control, glove-integrity assurance, and environmental control strategies).
Provides direct manufacturing floor leadership and execution support, actively participating in GMP processing, aseptic interventions, equipment setup, batch readiness walkthroughs, and deviation prevention strategies.
Authors and reviews SOPs, Work Instructions, Master Batch Records, and validation documents to ensure clarity, traceability, and regulatory alignment (FDA, EU Annex 1, and internal QMS governance).
Manage deviations, change controls, and CAPAs, applying 5M/5-Why/RCA methodologies and validated risk-management tools (FMEA, RPN scoring, impact assessments, and control-strategy design to ensure compliance with internal procedures and regulatory requirements.
Provide support for all related start-up and continuous improvement activities related to operational readiness and operational excellence, including procedure creation, revision, equipment qualification and validation.
Collaborates with QA, QC Microbiology, MSAT, Engineering, and Supply Chain to drive operational readiness, equipment qualification, data integrity, and continuous improvement for clinical and commercial manufacturing campaigns.
Provides manufacturing and operational guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
Maintaining personal responsibility with Personal Protective Equipment (PPE)
Proficient in Microsoft Word, Excel, PowerPoint, and other standard applications used in technical field.