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 assure 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 complexity 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 RTP, NC 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. 

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.

• In depth knowledge of aseptic processing/cell culture/cell therapy manufacturing in a cGMP setting.
• Provides direct on the floor support for manufacturing, including participating in daily GMP manufacturing activities.
• Author and reviews SOPs, Master Batch Records and related GMP documents.
• Manage deviations, change controls, and CAPAs 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.
• Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
• 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.

Qualifications

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

Required:

• B.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 5-7+ years of manufacturing experience
• 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. 
• Working knowledge of validation and related concepts.
• 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.

Preferred:

• 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.

Travel Requirements

• N/A

Location

• This is an office-based position located at the RTP, NC site.

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