Kincell Bio is hiring: Specialist, Manufacturing in Milwaukee

Overview

Kincell Bio is seeking a highly motivated Manufacturing Specialist who will be a key contributor to a dynamic and collaborative Manufacturing team. Kincell Bio engineers cells into therapies and operates manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL. We are a contract development and manufacturing organization (CDMO) focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. This role directly supports manufacturing for all production-related activities in a cGMP environment and involves operating cell therapy process equipment with varying levels of complexity in CAR-T, CAR-M, or CAR-NK processes.

For more information, please visit our website at www.kincellbio.com.

Responsibilities

• On-the-floor support for manufacturing, including daily GMP activities.
• Author and review SOPs, Master Batch Records, and related GMP documents.
• Manage deviations, change controls, and CAPAs to ensure compliance with internal procedures and regulatory requirements.
• Support start-up and continuous improvement activities related to operational readiness and operational excellence, including procedure creation, revision, equipment qualification and validation.
• Collaborate with cross-functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
• Provide manufacturing and operational guidance to internal and external stakeholders.
• Maintain awareness of PPE requirements and safety procedures.
• Operate cell therapy process equipment with procedures and policies as needed.
• Perform quality control analyses to support in-process batches and identify variations.
• Adhere to cGMP activities at the RTP, NC site and prioritize workflows based on process needs and available resources.
• Follow standard operating procedures to complete tasks of varying scope, complexity, and timing.

Qualifications

• Required
• B.S. degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (Chemical, Biomedical, etc.) with 5-7+ years of manufacturing experience
• Ability to work onsite daily with a flexible schedule to support multi-shift operations including 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
• Experience drafting and reviewing technical documents with strong technical writing skills
• Strong time management, reliability, and organization; proactive in identifying improvements
• Ability to apply risk management and root cause analysis tools
• Excellent listening and communication skills; collaborative and positive demeanor
• Ability to lift bags/containers of media up to 40+ lbs

• Preferred
• M.S. degree in Natural Sciences or Engineering with 3-5+ years of manufacturing experience
• Knowledge of cell and gene therapy processing, metric system, and scales
• Strong project management skills to meet project goals in a timely manner

Location

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

Travel

• N/A

Equal Opportunity

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. We comply with applicable laws governing non-discrimination in employment in every location where we operate.

NOTE TO EMPLOYMENT AGENCIES: We value our relationships with Recruitment Partners and will only accept resumes from contracted partners working with our Human Resources team.