As a Contingent Manufacturing Associate III, you will be responsible for operating both automated and manual cell therapy equipment of varying complexity to support CAR-T, CAR-M, or CAR-NK manufacturing processes, following established standard operating procedures and company policies. You will conduct quality control analyses to support in-process batch production and detect any process deviations. This role involves handling leukapheresis-derived cellular materials; therefore, you will receive comprehensive training in hazardous material handling and emergency response procedures.

As part of manufacturing operations, you will be expected to demonstrate a strong understanding of procedures, techniques, tools, materials, and equipment used in the production process. Your role will involve team-based decision-making, with a focus on prioritizing workflows based on process requirements and available resources. You will follow standard operating procedures to carry out tasks that may vary in scope, complexity, and duration.

Patients are counting on dedicated professionals like you—those who take pride in their work and strive for meaningful results. In this role, you'll play a vital part in ensuring life-changing therapies reach the patients who need them, exactly when they need them most!

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.

• Utilize proficiency in Microsoft Word, Excel, PowerPoint, and other software applications to support manufacturing operations and documentation.

• Apply knowledge of aseptic processing, cell culture, and cell therapy manufacturing within a cGMP-regulated environment.

• Adhere to all Personal Protective Equipment (PPE) requirements and maintain personal responsibility for safety and compliance.

• Collaborate with team members to create, review, and revise Standard Operating Procedures (SOPs).

• Perform Quality Control evaluations and testing to support manufacturing processes and ensure product quality.

• Execute proper material flow and disinfection procedures when transferring materials into cleanroom environments.

• Maintain accountability for personal safety and completion of required training in accordance with company and regulatory standards.

• Support quality and safety investigations by identifying issues, gathering data, and participating in root cause analysis.

• Apply a solid understanding of GxP regulations—including GMP, GLP, GCP, and GDP—in daily operations, and actively share this knowledge to support team compliance and continuous improvement.

• Conduct routine cleaning and sanitization of manufacturing equipment and cleanroom facilities per established procedures.

• Coordinate and communicate scheduling and training activities with external vendors and service providers.

• Proactively identify process gaps and areas for improvement and take initiative to implement changes.
• Provide training and guidance to junior manufacturing associates to support their development and readiness.

Qualifications

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

Required:

• High school diploma or equivalent, with 3–5 years of relevant education and/or work experience.

• Ability to work 40 hours per week, including weekends as needed.

• Proven ability to work independently and remain focused in a fast-paced environment with minimal supervision.

• Strong attention to detail and the ability to identify deviations in processes, procedures, equipment, materials, or products.

• Effective verbal and written communication skills.

• Demonstrated ability to collaborate effectively within a team-oriented environment.

• Consistent and reliable attendance and performance are essential.

• Flexibility to adapt to changing priorities and conditions in a dynamic work environment.

• Proficiency in basic math, including unit conversions (e.g., milliliters to liters, grams to kilograms).

• Understanding of significant figures and rounding techniques.

• Physically capable of lifting and pushing loads of 50+ pounds.

• Ability to stand or sit for extended periods, as required by job duties.
• Strong time management and self-motivation skills, with accountability for personal performance and task prioritization.

Preferred:

• Bachelor’s degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (e.g., Chemical, Biomedical), with 3–5 years of hands-on experience in a manufacturing environment.

• Experienced working in a cGMP-regulated cleanroom setting.

• Experienced in cell and gene therapy manufacturing processes, including accurate use of the metric system and weighing scales.

• Demonstrates ability to initiate, manage, and close deviations, change controls, and CAPAs, ensuring compliance with internal procedures and regulatory requirements.

Travel Requirements

• N/A

Location

• This is a site-based temporary position located in Durham, NC, and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.

#LI-Onsite