Engineering Jobs in Lawrence Township, NJ

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.

PrideNow is seeking an experienced Maintenance Electrician to join our team in a full-time, direct hire role. This position requires a highly skilled professional capable of performing complex industrial electrical maintenance in a manufacturing environment. Candidates with journeyman-level experience or 7–10 years of industrial electrical experience are strongly encouraged to apply.

Shifts Available:

• 2nd Shift: Monday–Friday, 2:00 PM–10:00 PM
• Pay Rate: $34.25/hr. plus $1 shift differential for 2nd shift
• Comprehensive benefits package to include Medical, Vision, Dental, PTO, 401k + Match, FSA etc.

Job Responsibilities:

• Identify electrical hazards and safely isolate, ground, and prepare circuits and equipment for repair.
• Use required PPE to protect against arc flash and electrical shock.
• Read, interpret, and troubleshoot from blueprints and schematics, including 240V and 480V three-phase systems.
• Troubleshoot and maintain motor control centers, motor start circuits, control loops, generators, high-voltage switchgear, protective relays, and related equipment.
• Install, calibrate, and maintain electrical apparatus using engineering drawings and manuals.
• Install conduit, pull wiring, and perform proper terminations.
• Use electrical and electronic testing equipment such as multimeters, ammeters, megohm meters, high-potential testers, oscilloscopes, and digital probes.
• Install and maintain electrical distribution and control equipment including switches, relays, circuit breakers, and panels.
• Install and maintain drive systems including VFDs, eddy current drives, and DC drive systems.
• Perform installation, maintenance, and troubleshooting of PLC systems, including point-to-point wiring and equipment replacement.
• Install and calibrate pressure, temperature, flow, and level control devices.
• Observe operating systems to detect hazards and determine need for adjustments or modifications.
• Design and lay out control panels, set up complex control systems, and modify engineering drawings when required.
• Repair or replace faulty electrical equipment, including electronic controls, motors, meters, outlets, and panels.
• Document work performed and communicate issues, irregularities, and ongoing needs to the team.
• Maintain a safe and clean work environment following all procedures and regulations.
• Communicate effectively to resolve electrical problems.
• Assist in training line mechanics and apprentices as needed.
• Use the computerized maintenance management system (CMMS) to enter and retrieve information.
• Follow safe work practices at all times and ensure work does not endanger others.
• Perform additional duties as needed.

Additional Requirement:

• Physical examination is required.
• Must be able to train on 1st shift for 1-2 weeks if needed
• Journeyman or electrical license preferred or 5+ years of experience as an electrician in a manufacturing plant

#SM

Princeton Theological Seminary, established in 1812, is dedicated to forming Christian leaders to serve Christ's church, academia, and the world. Located in Princeton, NJ, the institution is renowned for its commitment to theological education and fostering a community of faith and learning. The Seminary combines academic excellence with a rich history, providing an environment for students to grow spiritually and intellectually. With a global perspective, it prepares faith-driven leaders for impactful service.

This is a full-time, on-site Electrician role based in Princeton, NJ. The Electrician will perform installation, maintenance, and repair of electrical systems and equipment across campus facilities. Responsibilities include diagnosing and troubleshooting electrical issues, performing routine preventative maintenance, ensuring code compliance, and collaborating with the facilities team to uphold safety standards. The candidate will be required to handle various electrical tasks, ensuring operational efficiency for a safe environment.

• Proficiency in Electrical Work and Electricity, with the ability to install and maintain electrical systems
• Strong background in Maintenance & Repair tasks, ensuring equipment functionality and safety
• Skilled in Troubleshooting, identifying, and resolving electrical issues efficiently
• Understanding of Electrical Engineering principles and code compliance
• Excellent problem-solving and organizational skills
• Relevant certifications and licenses to perform professional electrical work
• Ability to work independently and collaboratively as part of a team
• Prior experience in facility management or academic settings is a plus

About the Role

The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

Responsibilities

• Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
• Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
• Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
• Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
• Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
• Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
• Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
• 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
• 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
• Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
• Proven experience tracking testing deliverables, coordinating QC schedules

Preferred Skills

• Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
• Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.

Global Product Quality Specialist

12-month Contract

Remote- EST Hours

Responsibilities:

• Quality Systems Support:
• Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
• Support of regulatory submissions, annual reports and preparation of annual product quality reviews
• Inspection readiness for Internal and external audits
• Compile metrics for continuous improvement initiatives
• Assist in the writing of Quality Agreements
• Documentation Review:
• Review of API, DP and Packaging batch records
• Review of test methods, component specifications, validation protocols/reports, BOM
• Review of stability protocols and reports, and data in LIMS
• Operational QA Support:
• Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
• Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
• Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
• Project QA Support:
• Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
• Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

• BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
• 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
• Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
• Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
• Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
• Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
• Strong written and verbal communication skills; ability to collaborate with cross-functional teams
• Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
• Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.

Company Description

JDC Energy Services, LLC (JDC), an affiliate of DCO Energy, LLC, and Joseph Jingoli and Son, Inc., is a leading energy engineering, procurement, and construction (EPC) firm. JDC specializes in self-funding energy efficiency projects for public and private clients through energy savings and comprehensive incentive programs. With expertise in demand-side energy management, supply-side optimization, and construction management, JDC provides cost-effective, energy-efficient upgrades to HVAC and lighting systems. Serving a diverse range of clients, JDC works with commercial, public, K-12, healthcare, higher education, manufacturing, gaming, industrial, and pharmaceutical entities to deliver measurable value and operational savings.

Role Description

This is a full-time hybrid role for an Energy Engineer II based between our Melville, New York and Lawrenceville, New Jersey offices with flexibility to work from home one day per week.

The Energy Engineer plays a key role in developing innovative energy conservation measures and demand‑side management strategies for buildings and facilities. Working closely with facility managers, this role conducts detailed energy assessments, performs on‑site investigations, and evaluates the performance of building systems.

The Energy Engineer prepares energy‑savings calculations, drafts clear and technically sound reports, and interprets engineering documents to support project planning and execution. They also monitor and support construction activities related to energy systems and equipment to ensure alignment with project specifications and industry standards.

In addition, the Energy Engineer provides technical expertise throughout project design and implementation to optimize system performance and achieve measurable energy and cost savings. The role also supports the Business Development team by evaluating potential opportunities and contributing technical insights during early‑stage project development

Responsibilities

• Performs technical energy audits and ECM payback calculations; drafts technical reports on findings.
• Provides engineering and technical support for project development and implementation and coordinates with facility personnel to optimize the operations and energy use of energy systems and equipment.
• Analyzes systems and equipment to determine optimum operating conditions and diagnose issues impacting energy consumption; develops and recommends strategies to maximize operating efficiency.
• Reviews data from Energy Management and Information Systems (EMIS), such as a building automation system, and utility billing and meter data to identify opportunities for energy and operational savings.
• Works with facility managers to implement effective and innovative energy conservation measures (ECMs) and demand-side management strategies in buildings and facilities.
• Researches, tests, and summarizes benefits of energy efficiency and renewable energy project concepts.
• Develops and delivers training on heating, ventilation, and air-conditioning (HVAC) controls and energy management for appropriate stakeholders.
• Advises on equipment specifications, conducts bidding process with equipment suppliers for upgrades and energy retrofits, and supports annual energy budget preparation.
• Reviews, monitors, and manages construction activities related to energy systems and equipment.
• Provides energy database support, including tracking and reporting of ECM and providing facility operational and use characteristics.
• Updates job knowledge by participating in educational opportunities, reading professional publications, maintaining professional networks, and participating in professional organizations.

Skills and Experience

• Knowledge of engineering practices and principles and experience in one or more of the following engineering fields: mechanical, environmental, civil, and electrical.
• Experience with building systems and equipment, including implementing energy efficiency measures and optimizing equipment use and scheduling to maximize energy and cost savings.
• Experience making routine determinations related to engineering principles and standards and offering recommendations for nonroutine matters.
• Experience interpreting engineering documents, evaluating construction plans, and using data from EMIS to monitor and control mechanical systems.
• Ability to perform technical analysis.
• Ability to verbally communicate technical and nontechnical information to various stakeholders.
• Familiarity with ASHRAE standards.
• Ability to manage time independently and meet schedules and deadlines.
• Ability to identify high-impact energy conservation measures and manager energy efficiency projects.

• Bachelor's degree in an applicable energy or engineering field, or other relevant degree from an accredited institution.

Engineer II – Mid Level (2–5 years)

• Demonstrated experience independently executing major portions of energy projects, including leading site assessments, performing energy and cost‑savings calculations, and managing technical deliverables. Capable of coordinating with facility staff, overseeing implementation tasks, and contributing to project planning and design.

Engineer III – Senior Level (5+ years)

• Extensive experience leading full‑cycle energy projects, from opportunity development through implementation and verification. Proven ability to manage client relationships, oversee multidisciplinary teams, develop advanced energy strategies, and ensure successful delivery of complex ECMs and system upgrades.

Take Your Environmental Career to the Next Level

Kleinfelder, a Forbes' Top Employer for Engineers in North America, is committed to a people-first culture, technical excellence, and creating opportunities where employees can thrive!

Are you ready to be challenged, make a difference, and experience professional growth in your career? Kleinfelder's Environmental team is looking for you! From environmental planning, permitting, remediation, and site characterization to chemical data management and hydrogeology, Kleinfelder offers a variety of services designed to provide technically appropriate and cost-effective solutions.

Step into Your New Role

As a Senior Civil / Environmental Engineer, you will work with our civil/environmental team performing technical evaluations, planning, design, and construction administration. This role will help lead, inspire, and support our civil and environmental disciplines, and most importantly help grow our portfolio of work with clients across multiple geographies, but primarily based in New Jersey.

This position is remote and will require approximately 40% travel to project sites primarily in New Jersey and other sites across the country.

Responsibilities:

• Strong experience with the design and construction of civil and/or environmental remediation projects.
• Leading technical efforts for planning, studies, budgeting, project cost estimating, technical management, coordination of multi-disciplinary engineering efforts, quality assurance, subcontract management and contract administration.
• Supervising staff and subcontractors to successfully deliver technical projects and build/mentor staff in the group.
• Ability to effectively communicate design concepts to clients, participating in project scoping activities and proposal presentations, and coordinating with clients to ensure an ongoing positive relationship.
• Establishing strong, productive internal collaborative relationships with senior management.

Qualifications:

• B.S. in civil, environmental, or chemical engineering.
• 12 + years of experience providing technical management of civil / environmental projects.
• Professional Engineering license with ability to obtain New Jersey license within 6 months of start date, if necessary.
• In-depth knowledge of large/complex civil/environmental projects and experience coordinating the various engineering disciplines for successful project completion.
• A strong work ethic with excellent organizational, communication, computer and technical writing skills.
• Strong team building and communications skills.
• Solid written and verbal fluency in English.
• Willingness to travel out of state.
• AutoCAD and Civil 3D experience preferred.

Move Forward with Kleinfelder

Kleinfelder has been connecting great people to the best work since 1961. We are engineers, scientists, and construction professionals providing solutions that improve our clients' transportation, water, energy, and other private infrastructure. As a responsive, cross-disciplinary team of bright, curious, and innovative problem-solvers, we are dedicated to doing the right thing, every day, on every project from over 85 offices in the US, Canada, and Australia. Connecting great people to the best work is our purpose - together, we deliver.

Progress with an Employer that Values You

Kleinfelder is an inclusive organization free from discrimination. We are a stronger organization when we are a diverse workforce and believe that throughdiversity, equity, and inclusion comes creativity, innovation, and unity. We are proud to offer the following:

Benefits: Kleinfelder offers an excellent compensation and benefits package, including medical, dental, vision, life insurance, 401(k) plan, and paid holidays.

New Jersey: The expected salary range for the position is displayed in accordance with the New Jersey Wage Transparency Law. Final agreed upon compensation is based upon individual qualifications and experience. Salary range: $131,000-$182,000.

Career Development: We are committed to investing in the professional development of our staff, offering each employee every opportunity to grow, develop, and take control of their career paths. We support these efforts through reimbursements for continuing education as well as many of the expenses associated with trainings and certifications, and opportunities for career development through our internal Mentoring Program.

Equal Opportunity: Kleinfelder is an Equal Opportunity Employer - Minorities/Women/Disabled/Veterans. (Compliant with the new VEVRAA and Section 503 rules)

NOTICE TO THIRD PARTY AGENCIES

Please note that Kleinfelder does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Fee Agreement, Kleinfelder will not consider or agree to payment for any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Kleinfelder explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resume, including those submitted to hiring managers, are deemed to be the property of Kleinfelder.

Java / Software Developer Opportunity @ BeaconFire

Location: East Windsor New Jersey

Visa Sponsorship Available | E-Verified Company

Kickstart Your Career with BeaconFire!

Are you passionate about coding and looking to grow your career in Software Development?

BeaconFire, based in Central NJ, is a leader in Software Development, Web Development, and Business Intelligence. We're on the lookout for dynamic individuals with a strong background in Software Engineering or Computer Science to join our team as Java / Software Developers!

What You'll Be Doing:

• Develop applications using Java 8/JEE (and higher), Angular 2+, React.js, SQL, Spring, HTML5, CSS, JavaScript, TypeScript, and more.
• Write scalable, secure, and maintainable code for high-impact client platforms.
• Create, deploy, and maintain automated system tests.
• Collaborate with testers to understand and resolve defects efficiently.
• Investigate new technologies and tools for continuous improvement and architecture reviews.
• Work closely with team members to achieve shared user story and sprint goals.

What We're Looking For:

• Experience in Java and JavaScript programming languages.
• A good understanding of the Software Development Life Cycle (SDLC).
• Strong object-oriented programming (OOP) skills and knowledge of Collections, Maps, Lists, Sets, and common APIs.
• Familiarity with relational databases like SQL Server or Oracle and basic SQL queries.

Preferred Qualifications:

• Master's Degree in Computer Science (CS).
• 0–1 year of hands-on experience in Java coding.
• Experience with Spring, Maven, Angular, HTML, and CSS.
• Knowledge of modern Java technologies like WebLogic, RabbitMQ, Tomcat.
• Familiarity with JSP, J2EE, and JDBC.

Why Join BeaconFire?

• E-Verified Employer
• Visa Sponsorship Provided
• Opportunities to work on cutting-edge tech
• Collaborative and growth-focused work culture

Apply Today and Build Your Future with BeaconFire!

Let's turn your passion into a profession!

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 Sterility Assurance Program Lead (Associate Director) is a quality and technical leader responsible for establishing, maintaining, and continuously improving a robust sterility assurance and contamination control program across GMP cell therapy operations, from clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual will work in close partnership with Technical Operations, QC, Site Quality Operations, Plant Operations, and MSAT to ensure consistent aseptic execution, clear functional accountability, and sustained compliance with global regulatory expectations for advanced therapies.

Key Responsibilities

Sterility Assurance & Contamination Control Program

• Design, implement, and sustain a comprehensive Sterility Assurance and Contamination Control Strategy (CCS) aligned with global GMP expectations for cell therapy manufacturing.

• Ensure sterility assurance principles are embedded across facility design, equipment, processes, personnel practices, and quality systems for both clinical and commercial operations.

• Maintain alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP Annex 1 & 2, ICH guidance, and evolving global expectations for ATMPs.

Aseptic Operations & Functional Ownership

• Define and govern clear functional ownership of sterility assurance activities across Technical Operations and Quality functions.

• Provide oversight to ensure appropriate independence, compliance, and cross-functional collaboration.

Environmental Monitoring & Data Oversight

• Oversee the design and maintenance of Environmental Monitoring (EM) programs, including EMPQ, EMRA, sampling plans, alert/action limits, and response strategies.

• Review EM trends and contamination indicators to maintain a sustained state of control.

• Lead cross-functional discussions on EM excursions, contamination events, and risk mitigation.

Aseptic Process Validation & Risk Management

• Provide sterility assurance leadership for aseptic process simulation and validation.

• Oversee media fill design, execution, and failure investigations.

• Lead contamination risk assessments for process changes, new equipment, facility modifications, or tech transfers.

• Drive root cause analysis and CAPA development related to sterility assurance events.

Quality Systems Interface & Continuous Improvement

• Author, review, and approve SOPs, policies, and standards related to sterility assurance and contamination control.

• Partner with Quality Systems to embed sterility assurance into deviation management, change control, CAPA, and training systems.

• Analyze sterility assurance trends to identify systemic risks and drive continuous improvement.

• Support sterility readiness for new site start-ups, expansions, tech transfers, and product launches.

Regulatory Inspections & Audit Support

• Act as Sterility Assurance SME during regulatory inspections, client audits, and internal audits.

• Lead inspection preparation, including gap assessments, mock audits, and SME coaching.

• Lead or support response drafting for sterility-related findings, including 483s, regulatory commitments, and client observations.

Leadership, Influence & Collaboration

• Provide mentorship and leadership to sterility assurance SMEs across sites.

• Influence and align stakeholders across Quality, Technical Operations, QC, MSAT, Facilities, and Program Management.

• Advise senior leadership on sterility assurance risks, contamination trends, and program maturity.

• Champion a proactive, science-based, and inspection-ready sterility assurance culture.

Required Qualifications

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

• 10+ years of progressive experience in GMP-regulated cell therapy, gene therapy, biologics, or advanced therapy manufacturing.

• Deep expertise in aseptic processing and sterility assurance for non-terminally sterilized products.

• Strong working knowledge of global GMP regulations (FDA, EMA, ICH, Annex 1).

• Demonstrated experience supporting clinical and commercial GMP operations.

• Proven ability to lead cross-functional programs and influence without direct authority.

• Strong communication skills for diverse audiences, from operators to regulators.

• Experience leading or supporting inspections, client audits, and internal audits.

• Flexibility to work variable hours to support operations and inspections.

• Strong organizational skills and ability to manage competing priorities.

Preferred Qualifications

• Experience working in a CDMO with multiple clients and programs.

• Direct experience with EU Annex 1 implementation and contamination control strategy.

• Experience supporting late-stage to commercial transitions or high-growth environments.

• Certification or training in microbiology, aseptic processing, Lean, or Six Sigma.

Education Requirement

• B.S. in a related field required.

Physical Requirements

• Ability to perform job functions in compliance with all standards, including productivity and attendance.

• Willingness to work in CNC/ISO7-8 cleanroom environments.

• Ability to lift up to 25 lbs.

• Must be able to stand, bend, and perform physical tasks in manufacturing environments.

• Comfortable working with cell-based products and chemicals.

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 Inspection Readiness Lead (Associate Director) is a quality leader responsible for establishing, maintaining, and continuously improving a state of inspection readiness across GMP cell therapy operations, spanning clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual partners closely with the Site Quality & GMP Compliance Lead and key cross-functional stakeholders to ensure GMP alignment, consistent execution, and inspection readiness across regulatory interactions.

Key Responsibilities

Inspection Readiness & Regulatory Compliance

• Design, implement, and sustain an inspection readiness program supporting clinical and commercial cell therapy manufacturing.

• Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits.

• Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies.

• Collaborate with Regulatory Affairs and the PMO to translate evolving regulatory and client expectations into actionable inspection readiness strategies, standards, and best practices.

Regulatory Inspections, Client Audits & Customer Assessments

• Serve as the front-room inspection lead for regulatory authority inspections and client audits.

• Lead and coordinate inspection and audit readiness activities, including mock inspections, readiness assessments, gap analyses, and SME coaching.

• Coordinate execution of inspections and audits, including inspection teams, war room operations, daily briefings, issue tracking, and executive updates.

• Lead the development and execution of inspection and audit responses, including FDA 483 observations, regulatory commitments, and client responses, ensuring consistency.

Quality Systems Interface & Continuous Improvement

• Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance.

• Analyze inspection and audit trends to identify systemic compliance risks and drive remediation and continuous improvement.

• Support inspection readiness for new site start-ups, facility expansions, technology transfers, and commercial launches.

Leadership, Influence & Collaboration

• Provide functional leadership and mentoring on inspection readiness to SMEs and site quality partners, fostering a culture of proactive compliance and inspection confidence.

• Align and influence stakeholders across Quality, Technical Operations, MSAT, Regulatory Affairs, and Program Management to drive inspection readiness initiatives.

• Serve as a trusted advisor to senior leadership on inspection risk, regulatory exposure, and readiness status.

• Champion a strong culture of quality and compliance, reinforcing consistent behaviors, decision-making, and regulatory interactions during audits and inspections.

Required Qualifications

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

• 10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics, with deep exposure to GMP operations.

• Strong expertise in cell therapy or ATMP manufacturing and in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW).

• Proven track record in a CDMO environment managing multiple client programs and regulatory compliance requirements.

• Demonstrated leadership during regulatory inspections, including FDA inspections and 483 resolution.

• Excellent verbal and written communication skills, with the ability to articulate complex compliance topics to inspectors, clients, and executive leadership.

• Experience leading audit and inspection planning, execution, and response activities.

• Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as needed.

• Strong organizational skills with the ability to prioritize and manage multiple demands while maintaining a solution-oriented mindset.

Preferred Qualifications

• Experience supporting multiple clients simultaneously within a CDMO.

• Direct experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch inspections.

• Experience supporting rapid-growth organizations, new site start-ups, or late-stage to commercial transitions.

• Lean, Six Sigma, or quality excellence certifications.

Educational Requirement

• B.S. in Life Sciences, Engineering, or related discipline required; advanced degree preferred.

Physical Requirements

• Ability to perform essential job functions in compliance with company standards, including productivity and attendance.

• Willingness to work in various controlled environments, including CNC/ISO7–8 cleanrooms.

• Ability to lift up to 25 lbs and perform physical tasks such as bending, standing, and working with cell-based products or chemicals.

• Must be flexible and adaptable to changing priorities and dynamic environments.