Information Technology Tourism Jobs in Pennington

Immediate need for a talented Specialist 4 - Medical Writing/Medical Writer, Medical Information, Payer and Health Systems. This is a 06 Months Contract opportunity with long-term potential and is located in Titusville, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-06073

Pay Range: $50 - $69/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Payer Scientific Content and Materials – 70%
• Supports the development and timely dissemination of tailored, evidence-based scientific materials for assigned therapeutic area products.
• Member of the multi-disciplinary team tasked with reviewing and approving of Payer regulated content prior to it being used
• Supports the development of AMCP standard and pre-approval dossiers, Medicaid formulary requests, and custom requests working collaboratively with Medical Affairs and Real-World Value & Evidence (RW V&E) therapeutic area leads.
• Engages in shaping and development of the Payer Digital Assets in collaboration with Med Info CSI/
• Digital partners.
• Works closely with RW V&E Field, Medical Affairs Therapeutic Area team(s) and Medical Information Scientific Engagement Contact Center to guide creation and delivery of responses to unsolicited Medical Information Requests from Payers and Health Systems
• Supports the development and dissemination of scientific information in support of assigned products to Clinical Decision Resource Organizations (CDRO) in partnership with Medical Information Affairs, RW V&E, SCG, Therapeutic Teams
• Support interactions with drug compendia and collaborates with AD, Med Info PHS and business partners to evaluate strategies for compendia interactions.
• Ensures optimized delivery of high-quality and efficient Payer scientific content and materials by vendors, provides real-time feedback and first line scientific review of materials as needed. Voice of Customer and Metrics – 20%
• Leverage voice of customer and other sources of customer information and identify actionable items to enhance the development of Payer and Health Systems materials.
• Projects and Research – 10%
• Participates in ad-hoc projects and activities as assigned by management.
• Conducts benchmark and research on the landscape of Payer, Healthcare Intermediaries, and health systems

Key Requirements and Technology Experience:

• Key skills: Payer Scientific Content and Materials
• Voice of Customer and Metrics
• Works closely with RW V&E Field, Medical Affairs Therapeutic Area team(s) and Medical Information Scientific Engagement Contact Center
• Excellence in leadership skills, collaboration in a matrix environment, influencing, ability to work both individually and as a team contributor
• Excellence in communication (both written and presentation), pharmaceutical industry experience
• Expertise in the healthcare industry, clinical knowledge, or practice across multiple therapeutic areas

Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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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.

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.

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.

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Role: Associate Account Manager

Job Description: Our AssociateAccount Manager (AAM) is an entry-level position within the agency and plays an important role on our client-focused Account Team. The AAM will be responsible for coordinating across the team on key project milestones and client meetings, serving as an internal and external resource for timelines and project status, and providing overall campaign support. This role is ideal for someone looking to grow into a client-facing account management position focused on relationship building, strategic thinking, and long-term client partnership.

Hybrid schedule: In-office 3 days per week

Must Have Core Responsibilities

• Thrive in a fast-paced, detail-oriented, and hands-on organization.

• Coordinate and implement successful projects from start to finish.

• Work closely with Account Managers regarding client expectations, deliverables, planning, and timeline development.

• Manage internal and external operational steps including tracking, routing, and communicating client expectations.

• Maintain relevant client and internal documentation and files.

• Demonstrate exceptionally strong organizational skills and good judgment to effectively manage and prioritize workflow.

• Assist with structuring and leading project status reviews; frequently communicate progress to ensure all key stakeholders are fully informed.

• Interact with all team members to maintain a comprehensive understanding of tactics and deliverables.

• Build strong working relationships across teams and with clients.

• Understand client review committee and submission processes (MLR, regulatory, etc.).

• Demonstrate the ability to learn new concepts, anticipate needs or changes, and problem-solve proactively.

• Perform additional responsibilities as required in support of client and team needs.

Qualifications / Essential Skills

• Bachelor’s degree (B.S./B.A.) in a relevant field required.

• 0–2 years of advertising agency or marketing department experience, with interest in pharmaceutical marketing or medical education.

Strong time-management and organizational skills.

• Strong verbal and written communication skills.

• Motivated, high-energy, and proactive self-starter.

• Exceptional attention to detail and ability to multitask in a deadline-driven environment.

• Collaborative team player who can also work independently when needed.

• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Good to have

EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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.