Information Technology Jobs in Kingston Estates, NJ

Infosys is seeking Java AEM Developer. This position will interface with key stakeholders and apply your technical proficiency across different stages of the Software Development Life Cycle including Requirements Elicitation, Application Architecture definition and Design; play an important role in creating the high level design artifacts; deliver high quality code deliverables for a module, lead validation for all types of testing and support activities related to implementation, transition and warranty; be part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded, and diversity is respected and valued.

Required Qualifications:

• Bachelor’s degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
• Candidate must be located within commuting distance of Boston, MA or Princeton, NJ or willing to relocate to the area. This position may require travel to project locations.
• Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time.
• At least 4 years of Information Technology experience
• 4 years of hands-on development experience in Adobe Experience Manager and Java.
• Strong experience with AEM as a Cloud Service and AEM On-Prem.
• In-depth knowledge of Sling, OSGi, JCR, Dispatcher, HTL, and AEM core architecture.
• Strong proficiency in Java, J2EE, Servlets, Spring (optional), and REST APIs.

Preferred Qualifications:

• Experience with unit testing frameworks like JUnit, Mockito, etc.
• Strong understanding of HTML5, CSS3, JavaScript, jQuery, and modern JS frameworks eg react JS.
• Design and develop complex components, templates, dialogs, and workflows within AEM.
• Build scalable, reusable, and maintainable AEM solutions aligned with enterprise architecture.
• Implement AEM as a Cloud Service features, including Sling models, Content Fragments, Experience Fragments, and Core Components.
• Upgrade, migrate, and optimize AEM On-Premises instances to AEM Cloud.
• Experience with CI/CD pipelines (Jenkins, GitHub Actions, Azure DevOps, etc.).
• Knowledge of cloud platforms: Adobe Cloud Manager, AWS/Azure/GCP (added advantage).
• Excellent problem-solving skills and performance debugging.
• Strong communication, documentation, and client-facing skills.
• Experience in Agile/Scrum environments.

Estimated annual compensation range for this role will be as follows:

In NJ/ MA: Min $76071 to Max $98893; Min $78903 to Max $102574

The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone, email or face to face. Travel may be required as per the job requirements.

EEO/About Us :

Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.

Junior Data Engineer

Location: East Windsor, New Jersey

E-Verified | Visa Sponsorship Available

About Us:

BeaconFire, based in Central NJ, is a fast-growing company specializing in Software Development, Web Development, and Business Intelligence. We're looking for self-motivated and strong communicators to join our team as a Junior Data Engineer!

If you're passionate about data and eager to learn, this is your opportunity to grow in a collaborative and innovative environment.

Qualifications We're Looking For:

• Passion for data and a strong desire to learn and grow.
• Master's Degree in Computer Science, Information Technology, Data Analytics, Data Science, or a related field.
• Intermediate Python skills (Experience with NumPy, Pandas, etc. is a plus!)
• Experience with relational databases like SQL Server, Oracle, or MySQL.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively within a team.

Your Responsibilities:

• Collaborate with analytics teams to deliver reliable, scalable data solutions.
• Design and implement ETL/ELT processes to meet business data demands.
• Perform data extraction, manipulation, and production from database tables.
• Build utilities, user-defined functions, and frameworks to optimize data flows.
• Create automated unit tests and participate in integration testing.
• Troubleshoot and resolve operational and performance-related issues.
• Work with architecture and engineering teams to implement high-quality solutions and follow best practices.

Why Join BeaconFire?

• E-Verified employer
• Work Visa Sponsorship Available
• Career growth in data engineering and BI
• Supportive and collaborative work culture
• Exposure to real-world, enterprise-level projects

Ready to launch your career in Data Engineering?

Apply now and let's build something amazing together!

Java Developer

Must have Java + Spring Boot

DESCRIPTION:

Job Responsibilities:

● Develop applications using Java 8/JEE (and higher), Angular 2+, React.js, SQL, Spring, HTML5, CSS, JavaScript and TypeScript among other tools.

● Write scalable, secure, maintainable code that powers our clients' platforms. ● Create, deploy and maintain automated system tests.

● Works with Testers to understand defects opened and resolves them in a timely manner ● Support continuous improvement by investigating alternatives and technologies and presenting these for architectural review

● Collaborates effectively with other team members to accomplish shared user story and sprint goals

Requirement:

● Experience in a programming language Java and JavaScript

● Decent understanding of the software development life cycle

● Basic programming skills using object-oriented programming (OOP) languages with in-depth knowledge of common APIs and data structures like Collections, Maps, lists, Sets etc.

● Knowledge of relational databases (e.g. SQL Server, Oracle) basic SQL query language skills

Preferred Qualifications:

● Master's Degree in Computer Science (CS)

● 0-1 year of practical experience in Java coding

● Experience using Spring, Maven and Angular frameworks, HTML, CSS ● Knowledge with other contemporary Java technologies (e.g. Weblogic, RabbitMQ, Tomcat, etc.) · Knowledge of JSP, J2EE, and JDBC

Job Title: Rancher & Kubernetes SME

Location: Princeton, NJ - 08540

Mode: Contract Role – Onsite

only W2

Minimum 15+ years of experience required.

Qualifications:

• Design and implement Rancher-managed Kubernetes clusters (RKE, RKE2, K3s, EKS, AKS, GKE).
• Architect high availability (HA) Rancher setups.
• Define multi-cluster and multi-tenant strategies using Rancher projects, namespaces, and RBAC.
• Integrate Kubernetes with VMware, Bare Metal, and Cloud platforms.
• Establish standardized cluster blueprints and reference architectures.
• Act as final escalation (L3) for Kubernetes and Rancher incidents.
• Diagnose and resolve Control plane failures
• etcd performance and corruption issues
• Pod scheduling and node pressure issues
• CNI (Calico / Cilium) networking problems
• CSI storage failures (Ceph, Longhorn, EBS, Azure Disk, NFS)
• Perform root cause analysis (RCA) and provide preventive recommendations.
• Install, upgrade, and maintain Rancher Server.
• Manage cluster lifecycles using Rancher UI & APIs.
• Implement and manage Rancher RBAC, Authentication (AD / LDAP / Azure AD / SSO)
• Global & cluster-level policies
• Maintain Rancher backups, DR, and recovery procedures
• Enforce Kubernetes security best practices like Pod Security Standards (PSS)
• Network policies and Secrets management
• integrate Kubernetes with CI/CD tools e.g., GitHub Actions, GitLab CI, Jenkins, Argo CD
• Enable GitOps workflows for application and cluster configuration.
• Support Helm chart development and lifecycle management.
• Assist development teams with Deployment strategies, Resource optimization
• Troubleshooting application issues on Kubernetes

Experience:

• 6–10+ years in Linux / Infrastructure / Cloud
• 3–5+ years hands-on Kubernetes production experience
• Strong expertise in Rancher (RKE / RKE2 / K3s)
• Deep understanding of:
• Kubernetes control plane
• etcd
• Networking (CNI)
• Storage (CSI)

Thanks,

Rahul Gupta

Direct: (732) 743-7543

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Director of Manufacturing Science & Technology (MSAT) will lead the technical oversight, process lifecycle management, and technology transfer activities for cell therapy manufacturing programs within a CDMO environment. This role is responsible for ensuring robust, scalable, and compliant manufacturing processes for autologous and allogeneic cell therapy products from clinical development through commercial manufacturing.

The Director will work cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and Client Program teams to support client programs, drive continuous process improvement, and ensure successful technology transfers into GMP manufacturing.

This role is based in Princeton, NJ and is fully onsite.

Key Responsibilities

• Provide scientific and technical leadership for cell therapy manufacturing processes, including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.

• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.

• Lead troubleshooting efforts and root cause analysis for manufacturing deviations, investigations, and CAPAs.

• Drive implementation of process monitoring and control strategies.

• Lead technology transfer activities from clients or internal process development teams into GMP manufacturing.

• Develop and review technology transfer plans, process descriptions, risk assessments, and gap analyses.

• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities, as applicable.

• Oversee continued process verification (CPV) and lifecycle management for manufacturing processes.

• Lead process characterization, comparability studies, and validation support activities.

• Provide real-time technical support to GMP manufacturing operations for clinical and commercial batches.

• Review batch records, deviations, and change controls related to process changes.

• Present technical updates during client meetings and governance reviews.

• Support proposal development, technical due diligence, and onboarding of new client programs.

• Ensure MSAT activities comply with cGMP, FDA, EMA, and ICH regulatory requirements.

• Contribute to regulatory filings, including INDs, BLAs, and comparability packages.

• Support regulatory inspections and client audits.

• Build and lead a high-performing MSAT team, including scientists and engineers.

• Provide mentorship, technical guidance, and performance management.

• Develop MSAT strategy aligned with organizational growth and client pipeline.

• Perform other duties as assigned by the Head of Development.

Required Qualifications

• PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or a related field.

• 10–15+ years of experience in biopharmaceutical manufacturing or process development.

• 5+ years of leadership experience in MSAT, technical operations, or process development.

• Strong experience in cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).

• Experience working within a CDMO environment strongly preferred.

• Deep knowledge of:

• Cell culture and expansion technologies

• Viral vector transduction or gene editing workflows

• Closed and automated cell therapy manufacturing platforms

• Cryopreservation and fill-finish processes

• Experience with technology transfer, process validation, and process characterization.

• Familiarity with statistical process monitoring and data analytics tools.

• Strong cross-functional leadership and project management skills.

• Experience working directly with biotech clients.

• Excellent written and verbal communication skills.

• Ability to operate in a fast-paced CDMO environment supporting multiple client programs.

Preferred Qualifications

• Experience with commercial cell therapy manufacturing.

• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).

• Knowledge of viral vector manufacturing processes.

• Experience supporting BLA submissions or late-stage clinical programs.

Physical Requirements

• Ability to perform essential job functions in compliance with ADA, FMLA, and other applicable regulations, including meeting productivity standards.

• Ability to maintain regular and punctual attendance.

• Must be willing to become gown-qualified and work in BSL-2 lab, CNC, ISO7, and ISO8 environments.

• Ability to lift and carry up to 30 lbs.

• Ability to bend, stoop, reach, climb, and stand on elevated surfaces as needed.

• Ability to sit or stand for extended periods.

• Must be comfortable working with cell-based products, chemicals, or hazardous materials.

Position Overview:

The Logistics Specialist plays a key role in supporting and optimizing end-to-end supply chain operations, including order processing, customer communication, inventory release, and coordination with transportation and third-party logistics providers. This position requires hands-on experience in logistics and operations, with a focus on using technology and process improvements to drive efficiency and accuracy. The role is critical in ensuring the timely and cost-effective movement of goods while maintaining strong relationships with internal teams and external partners. Success in this role requires strong communication skills, a solutions-focused mindset, and proficiency with ERP, MRP, and TMS platforms.

Principle Duties & Responsibilities:

• Order Management & Documentation: Accurately create and manage sales orders and release documents our ERP system (NetSuite), e.g., picking tickets, packing slips. Ensure shipment instructions are clearly communicated to 3PLs, warehouse staff, and carriers, adhering to both internal and customer-specific procedures
• Sales & Customer Support: Collaborate with sales reps, customers, and internal teams to provide timely updates on shipment status, pricing, and product availability. Respond to inquiries and resolve issues with a sense of urgency, empathy, and professionalism. Attend customer meetings as needed
• Logistics Coordination & 3PL Management: Coordinate inbound and outbound shipments of raw materials and finished goods, including refrigerated and dry products. Manage relationships with third-party warehouses and logistics providers to ensure proper handling, storage, and transportation of inventory
• Transportation & Carrier Management: Evaluate and select freight carriers based on cost, service quality, and reliability. Negotiate trucking contracts and spot rates when applicable. Utilize Transportation Management Systems (TMS) for order tracking, KPI monitoring, and operational reporting
• Inventory & Supply Chain Support: Collaborate cross-functionally to ensure timely movement of materials between production sites and warehouses. Monitor and report on shipment documentation, proactively follow up on discrepancies or delays, and work with accounting on freight invoice resolution
• Technology & Systems Usage: Effectively use ERP (NetSuite), MRP, and TMS software to manage logistics workflows. Participate in internal process systems to support continuous improvement and cross-team alignment
• Process Improvement & Optimization: Gain a deep understanding of order entry, customer support, and outbound logistics processes. Identify and implement process improvements through operational optimization, automation, and technology solutions, leveraging experience in logistics, brokerage, and manufacturing
• Other duties as assigned

Qualifications & Skills:

• Bachelor’s degree in Supply Chain, Business, Logistics, or a related field preferred (or equivalent work experience)
• 1–3 years of experience in logistics, supply chain, operations, or a related field, preferably in the food and beverage industry
• Proactive problem-solver with the ability to think critically and respond with urgency
• Familiarity with ERPs, Transportation Management Systems (TMS), and command of business technology (Microsoft Outlook, Excel, proficient in organizing files in OneDrive folders)
• Strong understanding of order fulfillment, inventory management, and transportation coordination
• Experience working with third-party logistics (3PL) providers or warehouse partners
• Excellent communication and customer service skills with the ability to manage internal and external relationships
• Strong organizational skills and attention to detail in a fast-paced environment

Job Title: Project Manager – US Field Medical Capabilities

Location: 50% Onsite – Lawrence Township, NJ 08648

Schedule: Monday – Friday | 8:00 AM – 5:00 PM

Duration: 12 Months Contract

Pay Rate: $69.00/hour (W2)

Position Overview

The Project Manager – US Field Medical Capabilities will provide operational and project management support for the Medical Engagement Excellence (MedEngageX) team. This role is responsible for coordinating projects, managing meetings and training initiatives, maintaining communication tools, and supporting key business processes across multiple therapeutic areas.

The position plays a critical role in ensuring efficient project execution, streamlined workflows, and effective cross-functional collaboration under the guidance of the team supervisor.

Key Responsibilities

Project & Operational Support

• Provide day-to-day administrative and project management coordination for the MedEngageX team.
• Plan and manage multiple projects, meetings, and departmental initiatives.
• Coordinate meeting logistics, scheduling, agendas, documentation, and follow-up actions.
• Maintain project trackers and facilitate communication among stakeholders.
• Partner with MedEngageX leadership to identify opportunities to improve workflows, standardize processes, and enhance operational efficiency.
• Identify opportunities where technology or AI solutions can improve productivity and streamline processes.

Congress & Booth Operations

• Coordinate Congress booth staffing, scheduling, and priority coverage with MedEngageX Directors and Field Medical teams.
• Assist in developing training materials and executive summaries for congress events.
• Establish centralized communication channels such as Microsoft Teams and OneNote for congress activities.
• Support post-congress follow-ups, including collecting session summaries, coordinating debrief sessions, and distributing key updates.
• Manage meeting logistics and reservations to ensure smooth operations during congress events.
• Support planning sessions with US Field Medical teams.

Medical Insights Support

• Coordinate Medical Insights meetings and conference calls.
• Maintain and update Medical Insights presentation decks.
• Assist with compiling and distributing call notes and insights summaries.
• Maintain and update therapeutic area distribution lists.

Clinical Trials Support

• Maintain clinical trial communication distribution lists and tracking tools.
• Support project coordination for priority clinical trials when needed.

SharePoint & System Support

• Maintain MedEngageX resources within SharePoint and Veeva Portal.
• Ensure version control, accessibility, and organized documentation across therapeutic areas.
• Support collaboration with Global Strategy & Operations teams for system updates and content management.

Intern Support

• Serve as a secondary point of contact for summer interns, helping them understand internal processes and the MedEngageX function.

Event Logistics Management

• Provide logistical support for US MedEngageX meetings and internal events.
• Assist in creating engaging communication materials such as podcasts, narrated presentations, videos, and interactive content.
• Support storage, archiving, and documentation management across MedEngageX platforms such as SharePoint and Vault.

Additional Responsibilities

• Conduct business in alignment with values and policies.
• Complete all required SOPs and training requirements within designated timelines.
• Maintain flexibility and adapt to changing priorities and deadlines.
• Assist in training new team members and supporting onboarding activities.
• Participate in professional development and on-the-job training initiatives.

Qualifications

• Minimum 4 years of experience in project management, administrative coordination, or operations support.
• Experience in biotech, pharmaceutical, or healthcare environments is preferred.
• Strong experience coordinating meetings, projects, and cross-functional initiatives.
• Demonstrated ability to manage multiple priorities and deadlines simultaneously.

Technical Skills

• Advanced proficiency with Microsoft 365 tools, including:
• Microsoft Word
• Excel
• Microsoft Teams
• SharePoint
• OneNote
• Outlook
• Familiarity with Veeva Portal or similar collaboration platforms is preferred.
• Comfort using emerging technologies and AI productivity tools (e.g., Copilot).

Core Competencies

• Excellent written and verbal communication skills
• Strong organizational and project coordination abilities
• High attention to detail and task management skills
• Ability to collaborate effectively across teams and geographies
• Ability to prioritize workload and manage competing deadlines
• Self-starter with strong accountability and professional maturity
• Ability to work independently with limited supervision
• Strong problem-solving and decision-making skills

About the Company: Canon Business Process Services, Inc. is a subsidiary of Canon USA that provides on-site managed workforce solutions to Fortune 100 clients.

About the Role: The Business Operations Manager will oversee daily operations for a corporate enterprise account. Will be responsible for conducting needs analysis and driving service levels across all workplace experience functions for multiple sites across the region.

Responsibilities:

• Responsible for oversight of daily operations within a corporate enterprise account
• Direct activities of on-site managers to drive productivity levels
• Monitor all assigned business units to ensure service levels are maintained
• Maintain relationships with client leaders to drive operational needs
• Monitors financial performance, budgeting, forecasting, and P&L
• Participate in regular meetings with C-Level executives
• Work with cross-functional stakeholders to drive service enhancements
• Assist in quarterly business reviews and sales presentations

Qualifications:

• Bachelor’s degree required
• 5 years of regional operations management with a Fortune 100 enterprise account
• Experience in corporate facilities or hospitality
• Experience managing a team with at least 5-10 direct reports
• Proven ability to manage relationships with C-Level executives
• Experience developing workplace solutions and technological enhancements
• Proficient use of Microsoft Office Suite and Facilities Software

Required Skills:

• Experience in corporate facilities or hospitality
• Regional Operations Management
• Client relationship management

Preferred Skills:

• Technological enhancements
• Project management
• Financial performance monitoring

Salary: $125,000-$150,000

Equal Opportunity Statement: We are committed to diversity and inclusivity in our hiring practices.

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

Key Responsibilities

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.

• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.

• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.

• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.

• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.

• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.

• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.

• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.

• Minimum 1 year of leadership, supervisory, or management experience (preferred).

• Prior experience in manufacturing, quality, or engineering is required.

• Excellent communication, leadership, and organizational skills.

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

Preferred Qualifications

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.

• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Regular, punctual attendance is required.

• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.

• Must be able to lift up to 25 lbs.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be able to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.