Specialist, Manufacturing Job at Kincell Bio, LLC in Durham

Overview

Kincell Bio is a contract development and manufacturing organization (CDMO) with facilities in Research Triangle Park, NC and Gainesville, FL. We focus on streamlining CMC development, applying expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. We support 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.

Responsibilities

• In-depth knowledge of aseptic processing/cell culture/cell therapy manufacturing in a cGMP setting.
• Provide direct on-the-floor support for manufacturing, including participating in daily GMP manufacturing 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 startup 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 and recommendations to internal and external stakeholders in a professional and collaborative manner.
• Maintain Personal Protective Equipment (PPE) compliance and safety practices.
• Proficient in Microsoft Word, Excel, PowerPoint, and other standard applications used in a 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 (e.g., Biology, Chemistry) or Engineering (Chemical, Biomedical, etc.) with 5-7+ years of manufacturing experience
• Ability to work onsite daily and flexible schedule to support a multi-shift operation 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 high technical writing skill
• Demonstrates prompt, efficient, dependable, and high-quality service
• Uses appropriate risk management and root cause analysis tools
• Initiates improvement suggestions to promote operational goals
• Applies Quality concepts and company policies to resolve issues of moderate complexity
• Understands strategies and goals and can contribute to major parts of projects or provide expert service
• Recommends improvements to ongoing processes and projects
• Designs processes with Quality built in from the beginning
• Identifies and uses sound judgment to handle out-of-compliance situations
• Good listening and communication skills
• Positive, collaborative demeanor
• Must be able to lift bags and/or containers of media up to 40+ lbs
• Manages personal time and professional development; maintains accountability for outcomes and prioritized workflows

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
• Excellent project management skills to ensure projects and goals are met timely

Travel

• N/A

Location

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

EEO

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants 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 laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location where the company has facilities. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.