Cellular Therapy Manufacturing Associate

Location: Allendale, NJ

Job Type: Full-time, On-site

Department: Manufacturing

Position Summary:

We are seeking a Cellular Therapy Manufacturing Associate who is responsible for performing manufacturing operations to support the production of CAR T Cell therapies in accordance with current Good Manufacturing Practices (cGMP). In this role, the associate will follow established SOPs, maintain accurate batch records, and uphold quality and safety standards throughout the production process. The role requires hands-on aseptic processing, routine cell culture and the operation of GMP equipment to ensure quality and reproducibility of manufacturing runs.

Key Responsibilities: 

• Perform aseptic techniques in a GMP environment.

• Follow and execute Standard Operating Procedures (SOPs) for cellular therapy manufacturing and train others on basic SOPs, equipment and processes.

• Perform cellular therapy manufacturing tasks in compliance with applicable regulations, International Standards, and iCell Policies and Standard Operating Procedures.

• Able to operate and maintain equipment.

• Prepare solutions, reagents, and materials according to established procedures. 

• Utilize basic technical knowledge to support daily manufacturing activities. 

• Assist in execution of validation studies and associated documentation.

• Receive and organize materials as needed for production and identify material discrepancies promptly.

• Execute Batch Records (BRs) and contribute to revisions and approvals.

• Use applicable support systems to manage data and documentation.

• Collaborate with supporting departments as needed to facilitate manufacturing activities.

• Accurately collect, document, and record scientific and process data following good document practices.

• Adhere to all regulatory, compliance, and GMP requirements. 

• Support the development of technical documents, including deviation reports and non-conformance documentation.

• Identify improvement ideas and help troubleshoot operational issues. 

• Participate in regulatory inspections and audits as required.

• Uphold professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. 

• Contribute to department objectives and overall operational success.

Knowledge, Skills & Ability: 

• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.

• Strong understanding of manufacturing workflows, processes, and operations.

• Must be able to perform effectively under direct supervision. 

• Must wear appropriate clean room attire and all Personal Protective Equipment (PPE).

• Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.

• Holiday and shift work often required based on manufacturing schedule as determined by Management.

• Proficient in oral and written communication skills, with the ability to read, write, and understand English. 

• Proficient in Microsoft (Excel, Word, Outlook)

General Requirements

• Bachelor’s degree (biological sciences preferred) with at least 2 years of experience. 

• Legally authorized to work in the United States without visa support

• A valid driver’s license, ability to commute to the work site

Experience:

• Hands on cellular therapy manufacturing experience (at least 2 years).

• Experience operating in controlled environments under GMP regulations.

• Extensive experience in tissue culture and aseptic technique. 

Disclaimer:

The information provided in this job description reflects the general scope and nature of the work expected. IT is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the role. Assigned tasks and responsibilities may be modified at any time, with or without notice.  

Research & Development Associate

Location: Allendale, NJ

Job Type: Full-time, On-site

Department:  Research & Development

Position Summary:

We are seeking a highly motivated Research & Development Associate to join our preclinical team advancing next-generation CAR-T and CAR-NK therapies. In this role, you will contribute to the discovery of early developmental studies aimed at assessing the efficacy, safety, and biological mechanisms of cellular therapy products. Candidates should have hands-on experience with in vivo mouse models and foundational immunology or cancer biology techniques. In this role, candidates will collaborate closely with a multidisciplinary team to conduct in vitro experiments, process and analyze samples, perform flow cytometry, and support assay development for emerging cell-based therapeutics. 

Key Responsibilities: 

• Support in vitro assays related to CAR-T/CAR-NK research, including cytotoxicity assays, proliferation, cytokine measurements, cell culture, and sample preparation.

• Perform multicolor flow cytometry for immune cell phenotyping, functional analysis, and CAR expression validation.

• Maintain accurate records in lab notebooks and study logs.

• Assist in preparation, analysis, and presentation of study data. 

• Partner closely with senior scientists and cross-functional colleagues to support ongoing research and project goals.

• Adhere to all laboratory safety procedures and company policies.

• Perform experimental studies to support the development and optimization of cellular therapy process workflow. 

• Contribute to inventory management, reagent preparation, and general lab operations to maintain the R&D environment.
  
  Knowledge, Skills & Ability: 

• Knowledge of cellular therapy preclinical workflows, including cell culture, CAR-T cell generation, or primary immune cell handling.

•  Proficiency in flow cytometry, including sample staining, instrument operation, and basic data analysis (FlowJo or similar).

• Experience with tumor models (liquid or solid tumor) is a plus.

• Strong attention to detail, ability to follow SOPs, and maintain consistent documentation. 

• Ability to manage multiple tasks and timelines in a fast-paced environment.

• Strong communication and teamwork skills.

• Problem-solving mindset and willingness to learn new techniques.

• Experience with the operation and maintenance of essential laboratory equipment. 

General Requirements

• BS or MS degree in Immunology, Cell Biology, Cancer Biology, Molecular Biology, or a related field. 

• Legally authorized to work in the United States without visa support

• A valid driver’s license, ability to commute to the work site

Experience:

• Experience with cellular therapy platforms including tissue culture, aseptic technique, and in vitro assays required. 

• Hands on in vivo experience with mice is required, including injections, blood collection, IVIS bioluminescence imaging and data analysis. 

• Prior biotech or pharmaceutical industry experience is preferred.

Cellular Therapy Site Head:

Location: Allendale, NJ

Job Type: Full-time, On-site

Department:  Technical Operations Leadership

Position Summary:

We are seeking a Cellular Therapy Site Head to join our team based in Allendale, NJ. The Cellular Therapy Site Head oversees strategy and operational execution for all of the company’s technical operations functions including compliance, facilities operations, and building management to support GMP activities. This role is responsible for managing all regulatory, quality, manufacturing, supply chain, safety, and operational standards required for manufacturing in a GMP environment. This position serves as the internal facilitator of communication between internal teams, regulatory bodies, vendors, and quality functions to maintain a fully compliant production facility.

Key Responsibilities: 

• Serve as the head of the technical operations team and facility, ensuring operational execution in alignment with key corporate goals and timelines. 

• Manage all facility programs, procedures and work practices to maintain safe, compliant, and efficient operations, ensuring proper documentation, traceability, and adherence to GMP standards. 

• Partner with clinical operations to ensure the optimal clinical trial site experience; from apheresis receipt through to drug product delivery. 

• Ensure that all activities within the facility comply with cGMP, SOPs and regulatory requirements for clinical manufacturing of autologous cell therapy products; write, review, approve, and implement SOPs related to the facility and equipment operation. 

• Make day-to-day operational decisions for the department within the approved budget and escalate major issues as needed.

• Ensure facility compliance with licensing, inspections, and permit requirements at the local, state and federal level.

• Support long-term planning, including departmental budgeting, vendor management, and operational strategy.

• Serve as the primary point of contact for internal teams to assess and address facility, utility, and equipment requirements. 

• Oversee the maintenance and collaboration of process and laboratory equipment to ensure operational readiness; Coordinate and execute IQ/OQ/PQ of new and existing equipment in the GMP environment. 

• Ensure facility compliance with licensing, inspections, and permit requirements at the local, state and federal level. 

• Respond in emergency situations in a manner proportional to the situation, prioritizing safety and continuity of operations.

• Oversee training programs to ensure personnel are compliant with GMP, safety, and facilities-related procedures.

  
  Knowledge, Skills & Ability: 

• Thorough understanding of cGMP, GAMP, and FDA regulatory requirements related to autologous CAR T cell manufacturing. 

• Demonstrated experience in implementing and managing technology platforms for manufacturing, supply chain, and data management. 

• Strong knowledge of equipment qualification (IQ/OQ/PQ), calibration, validation and maintenance programs. 

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Strong quality Management knowledge, including change control, deviation, and CAPA’s.

• Knowledge of EHS and regulatory standards (EPA, OSHA, FDA) working knowledge of mechanical, electrical, and automation/controls.

• Maintenance and calibration of building operations and laboratory equipment.

• Proficient in Building Management systems.

• Ability to work independently and successfully, and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.

• Ability to develop relationships with internal customers and external vendors to drive facility operations.

General Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.

• Legally authorized to work in the United States without visa support

• A valid driver’s license, ability to commute to the work site

Experience:

• 7-10 years of experience working in a pharmaceutical or GMP facility. 

• A minimum of 3 years of experience managing a cell and gene manufacturing facility.

Cellular Therapy QA/QC Head:

Location: Allendale, NJ

Job Type: Full-time, On-site

Department:  QA/QC Department

Position Summary:

The Cellular Therapy QA/QC Head is responsible for all Quality Assurance (QA), Quality Control (QC), and compliance functions supporting clinical manufacturing operations on-site. Ensures full adherence to global regulatory requirements, internal quality standards, and client quality agreements. The Cellular Therapy QA/QC Head will be responsible for defining, implementing, and overseeing all aspects of the company’s Quality Management System (QMS). As a key member of the site leadership team, this role drives a strong culture of quality, proactive risk management, operational excellence, and continuous improvement across all site activities. This role requires extensive experience with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). The individual will ensure that all operations, from raw material sourcing and manufacturing to product release and patient delivery, are fully compliant with global regulatory requirements (ex. FDA, EMA).

Key Responsibilities: 

• Develop, implement, and manage a scalable and robust Quality Management System

• Serve as the site’s quality leader, ensuring quality standards and principles are fully integrated into all functions and daily operations. 

• Act as the final authority for product quality decisions, including escalations and batch release, to protect patient safety and regulatory compliance. 

• Manage the processes for product lot disposition, audits, deviation management, document management, change control, CAPA, and training. 

• Act as the quality oversight for the entire cellular therapy manufacturing process including apheresis, cell modification, expansion, and cryopreservation. 

• Manage and approve critical quality events including deviations, CAPAs, change controls and out of specification (OOS) results. 

• Establish and manage stability programs to ensure product integrity throughout its shelf life. 

• Lead all preparation, hosting, and response activities for inspections and audits and report results and regulatory updates to the relevant departments.  

• Maintain the site in a continuous state of regulatory inspection readiness in accordance with GMP requirements. 

• Serve as the primary quality liaison with regulatory agencies and external partners.

• Ensure site licenses, certifications, and registrations remain current and compliant with evolving regulations. 

• Work to design, implement, and maintain a harmonized training program ensuring proficiency in GMP, aseptic practices, documentation, deviation management, and inspection preparedness. 

• Lead the site quality reviews to evaluate performance trends, escalate critical risks, and drive continuous improvement.

• Provide strategic oversight and expert interpretation of global cGMP and other quality system requirements for cellular therapies to cross-functional teams.

  Knowledge, Skills & Ability: 

• Deep knowledge of GMP, aseptic manufacturing, and analytical QC concepts. 

• Experience with compliance audits and regulatory agency engagement.

• Strong leadership ability, able to drive change and develop high-performing teams. 

• Strong proficiency in root cause analysis, risk management, and regulatory strategy.

General Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field. Advanced degree preferred.

• Legally authorized to work in the United States without visa support

• A valid driver’s license, ability to commute to the work site

Experience:

• 5-10+ years of senior leadership experience in QA/QC roles within biopharma or manufacturing.

• Experience in cellular therapy manufacturing is preferred.

Building and Facility Manager :

Location: Allendale, NJ

Job Type: Full-time, On-site

Department:  Facilities & Engineering

Position Summary:

We are seeking a Building Manager to oversee and manage all aspects of the production facility infrastructure, maintenance, and operations. This role ensures that the GMP cleanroom systems, utilities, security and facility infrastructure are reliable and efficient to support manufacturing operations. The ideal candidate will have experience managing facilities and facility-related projects within a regulated environment, with a strong technical knowledge of building utility systems.

Key Responsibilities: 

• Oversee the day-today operation and maintenance of all facility systems including HVAC, electrical distribution, plumbing, compressed air, cooling systems, vacuum systems, specialty gases, and more. 

• Ensure the scheduling and maintenance of all mechanical systems and building operations including: utilities, purified water systems, boilers, compressed air systems, HVAC systems, material storage chambers, etc.

• Manage and optimize environmental controls (temperature, humidity, particulate levels) of the cleanroom.

• Manage waste disposal programs, including hazardous waste removal, air emission, and wastewater discharge, to ensure compliance with all regulations. 

• Plan and execute facility-related projects such as upgrades, renovations, equipment installation, repairs, etc. 

• Participate in the development and implementation of emergency response plans (fire, chemical spill, power outage, etc.)

• Maintain all records of facility maintenance projects and documentation related to facility operations. 

• Ensure compliance with all federal, state and local EH&S controls such as OSHA and EPA.

• Investigate all facility-related incidents/accidents and implement corrective actions. 

• Manage contracts with external vendors and service providers (HVAC, electrical, plumbing, etc.) to meet the company's needs. 

• Oversee the security of the building including access control systems, surveillance, and alarm systems. 

  
  Knowledge, Skills & Ability: 

• Strong knowledge of EH&S regulations relevant to GMP manufacturing environments. 

• Proficient in building management systems.

• Ability to work independently to manage multiple tasks simultaneously, and balance priorities effectively. 

• A strong working knowledge of mechanical, electrical and automation controls. 

• Understanding of relevant federal, state, and local regulations. 

• Knowledge of security protocols, risk assessments, and emergency response planning. 

• Strong project management and decision-making skills. 

• Ability to perform physical tasks related to building upkeep.

• Flexibility to respond to emergency situations outside of working hours.

General Requirements

• Bachelor’s degree in engineering (mechanical, electrical, facilities management), Occupational Safety and Health, or a related field. 

• Legally authorized to work in the United States without visa support

• A valid driver’s license, ability to commute to the work site

Experience:

• 5-10 years of experience working in a pharmaceutical or GMP facility

• Minimum of 5 years of facility management experience.

• Experience managing HVAC, electrical and plumbing systems.

Disclaimer:

The information provided in this job description reflects the general scope and nature of the work expected. IT is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the role. Assigned tasks and responsibilities may be modified at any time, with or without notice.