Manufacturing Associate I

Kincell is seeking a highly motivated Associate I, who will be a key contributor to a dynamic and collaborative Manufacturing team.

As a Manufacturing Associate, you will be operating automatic and manual cell and gene therapy equipment with a variety of complexities in CAR-T, CAR-M, or CAR-NK processes in accordance with standard operating procedures and policies.  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.  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.  You will contribute to the team’s success by sharing knowledge. 

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 and gene therapy process equipment of varying complexity with different processes in accordance with standard operating procedures. 

Essential Duties and Responsibilities

Reasonable accommodations 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.

• Execute GMP manufacturing operations under approved SOPs and Master Batch Records (MBRs) with strict adherence to GDP and Right-the-First-Time principles.
• Perform hands-on manufacturing tasks including material preparation, aseptic manipulations, basic cell culture activities, formulation support, and final drug product fill support under supervision.
• Operate and support manufacturing equipment relevant to cell and gene therapy processing following approved procedures and training qualification.
• Demonstrate and maintain aseptic technique qualification and comply with gowning, cleanroom behavior, and contamination control expectations.
• Accurately document all manufacturing activities in batch records, logbooks, and electronic quality systems (e.g., training records, controlled documents, deviation support tools).
• Perform routine cleaning and sanitization of manufacturing equipment, rooms, and classified areas per approved procedures.
• Support material handling activities, including material receipt, verification, staging, and controlled introduction into classified manufacturing spaces.
• Perform basic calculations (volumes, concentrations, dilutions, unit conversions) using approved tools and spreadsheets.
• Work within established Quality Management Systems (QMS) (e.g., Veeva or equivalent) to complete training, access controlled documents, and support quality records.
• Demonstrate proficiency in Good Documentation Practices (GDP) across both paper-based and electronic systems.
• Utilize Microsoft Office applications (Excel, Word, PowerPoint) for documentation, data entry, basic data review, training materials, and operational support tasks.
• Support Quality and Safety investigations by providing accurate, timely input within approved quality systems.
• Identify and escalate documentation errors, system discrepancies, or workflow issues impacting compliance or execution.
• Develop a working knowledge of GxP principles (GMP, GDP, GLP as applicable) and apply them consistently during manufacturing execution.
• Recognize and promptly escalate out-of-specification conditions, deviations, or atypical events related to equipment, materials, processes, or documentation.
• Maintain compliance with all required training, qualifications, and electronic learning assignments within the QMS.
• Maintain personal accountability for PPE use, safety practices, and cleanroom discipline.
• Collaborate with peers, Manufacturing Leads, and cross-functional partners (QA, MSAT, Engineering) during manufacturing execution, documentation readiness, and issue resolution.
• Contribute to continuous improvement by identifying process inefficiencies, documentation gaps, or system usability issues and escalating through appropriate channels.
• Support the development and revision of SOPs, MBRs, and Work Instructions as a technical contributor.
• Share knowledge and best practices to support team consistency and operational excellence

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

Required:

• Education and Experience (one of the following):
  • Bachelor’s Degree (BS) in Life Sciences, Engineering, or related field with 0–1+ years of relevant experience in GMP manufacturing, laboratory, or regulated environments.
  • Associate’s Degree (AS) in Life Sciences, Engineering, or related technical discipline with a minimum of 1+ year of relevant experience in GMP manufacturing or regulated environments.
  • High School Diploma (or equivalent) with a minimum of 3+ years of relevant experience in GMP manufacturing, regulated laboratory operations, or comparable technical environments.
• Proficiency with Microsoft Excel, Word, and PowerPoint for routine documentation, data entry, and operational support.
• Ability to navigate and work within electronic Quality Systems (e.g., Veeva, LMS, document management platforms).
• Strong attention to detail with the ability to identify documentation, process, or compliance risks.
• Ability to work independently in a fast-paced, highly regulated environment.
• Effective verbal and written communication skills.
• Ability to adapt to changing priorities and manufacturing schedules.
• Ability to meet physical requirements of the role (lifting media containers, extended standing/sitting).
• Successful completion of visual acuity requirements as applicable.

Preferred:

• Prior experience in cell or gene therapy manufacturing, aseptic processing, or cell culture operations.
• Experience working in cGMP cleanroom environments (ISO 5–8).
• Familiarity with Veeva Vault or similar enterprise Quality Systems.
• Exposure to electronic batch records, controlled documentation systems, or deviation support workflows.

Travel Requirements

• None

Location

• This position is 100% on-site in Durham, North Carolina. This position requires some non-standard working hours, including early morning or late evening.

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