Engineering Structures Jobs in Princeton, NJ

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.

Title: Contracts Compliance Manager

Pay: $130,000 – $160,000 base + bonus potential

Location: Hamilton Township, NJ | Fully onsite with up to 25% travel (primarily to east coast HQ and field offices)

Company: Confidential manufacturing subsidiary of a publicly traded clean energy company

About the Role

A newly created, high-visibility opportunity for an experienced Contracts Compliance Manager to lead contract negotiation, administration, and compliance for both commercial and government sectors. This role supports a fast-growing manufacturing site and works cross-functionally with leadership, engineering, finance, and sales to manage contract risk, ensure FAR/DFARS compliance, and support real-time business decisions.

Responsibilities

Contract Management & Negotiation

• Draft, review, and negotiate a wide range of contracts (government, commercial, subcontracts, NDAs, POs, and MSAs).
• Oversee cradle-to-grave contract administration and ensure timely fulfillment of obligations.
• Lead contract negotiations with customers and vendors, balancing business goals with risk mitigation.
• Review RFPs/RFQs to ensure compliance and recommend appropriate risk management terms.

Compliance & Risk Oversight

• Ensure full compliance with FAR/DFARS and other government contracting requirements.
• Maintain alignment with public-company policies and standards.
• Partner with internal teams on audits, reporting, and documentation accuracy.
• Provide training and guidance to stakeholders on contract and compliance requirements.

Cross-Functional Collaboration

• Work closely with the General Manager, Engineering, Sales, and Finance teams.
• Support process improvements, revenue recognition, and operational efficiency initiatives.
• Serve as a subject matter expert on all contract compliance and policy interpretation.

Requirements

• Bachelor’s degree in Business, Legal Studies, Government Contracting, or related field (JD preferred).
• Minimum 5+ years managing both commercial and government contracts in manufacturing, defense, or industrial environments.
• Proven success in managing contracts cradle-to-grave and navigating FAR/DFARS.
• Product-based contract experience required (not software/IP).
• Strong drafting, negotiation, and analytical skills.
• Excellent communication and relationship management abilities.
• Experience with compliance initiatives or process improvement preferred.

Preferred Attributes

• Hands-on, adaptable team player with a proactive mindset.
• Strong business judgment and ability to work independently.
• Comfortable in a fast-paced, evolving environment.
• Sense of humor, accountability, and collaborative spirit highly valued.

Culture & Growth

• Tight-knit, collaborative team where everyone “rolls up their sleeves.”
• Exposure to senior leadership and opportunities to shape policies and processes.
• Onsite culture that values initiative, learning, and cross-functional visibility.
• Long-term stability with the backing of a publicly traded clean energy leader.

Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the greater New York, New Jersey and Connecticut markets with a rail-served landfill in Ohio.  IWS is committed to delivering high-quality waste, recycling and environmental services, while prioritizing the safety of our employees, customers and communities. We cater to a diverse range of industrial, medical and commercial/residential customers.

Founded in 1998, IWS has grown over the years through acquisitions, many of which were family-owned businesses that remain a part of our team today. We’re proud to combine the resources of a large company with the values and care of a family-run business.

The Level B Fleet Mechanic/Technician is a journeyman-level role responsible for independent diagnosis and repair of most mechanical, electrical, and hydraulic issues on refuse trucks, heavy trucks/tractors, trailers, and heavy equipment. This role also mentors Level C technicians, supports road calls, and ensures high uptime and DOT compliance for the fleet.

• Diagnostics & Repair

  • Independently diagnose and repair:
    • Diesel and gasoline engines (intake, fuel, cooling, aftertreatment/emissions components).
    • Drivetrain components including clutches, transmissions, differentials, PTOs, and drive lines.
    • Air and hydraulic brake systems, ABS, and suspension components.
    • Hydraulic systems on refuse equipment (packer bodies, arms, cylinders, pumps, valves, and hose routing).
    • Electrical systems including starting/charging, multiplex wiring, sensors, and lighting.

   

  Preventive Maintenance & Compliance

  • Perform and sign off on DOT-compliant inspections and PMs, ensuring all safety-critical items are addressed and documented.
  • Accurately interpret and close out DVIR/eDVIR defects; communicate recurring defects to leadership for root-cause analysis.
  • Use OEM and aftermarket diagnostic software, service bulletins, and wiring schematics to troubleshoot complex issues.

   

  Road Calls & Operational Support

  • Respond to road calls and breakdowns throughout the NYC tri-state area; perform safe temporary or permanent repairs to return vehicles to service or coordinate towing as needed.
  • Communicate clearly with dispatch, supervisors, and drivers on repair status and estimated completion times.

   

  Mentorship, Training & Documentation

  • Guide and mentor Level C technicians on best practices, safety, troubleshooting, and proper repair methods.
  • Complete work orders thoroughly, capturing complaint, cause, correction, labor hours, and parts used.
  • Support continuous improvement initiatives for PM compliance, repeat repair reduction, and parts standardization.

• High school diploma or GED required.
• 3–5+ years hands-on experience as a diesel, truck, or heavy equipment mechanic/technician, including diagnostics and major component replacement.
• Valid CDL Class B (or higher) with air brake endorsement strongly preferred to perform road tests and move equipment on public roads within NY/NJ/CT.
• Demonstrated proficiency with hydraulic, pneumatic, and electrical systems.
• Ability to read and interpret OEM service manuals, wiring diagrams, and hydraulic schematics.
• Experience in refuse/solid waste, municipal, or LTL/heavy trucking fleet operating in urban environments preferred.
• ASE certifications in Medium/Heavy Truck (T series) or Truck Equipment (E series); working toward Master status preferred.
• Basic welding and cutting skills (MIG, stick, torch) for brackets, hangers, and minor body fabrication preferred.
• Familiarity with computerized fleet maintenance and parts inventory systems preferred.

This job description is intended to be an accurate representation of the general functions of the job, rather than exhaustive list of duties, responsibilities, or experience. Other duties may be assigned, requested, or required. Aspects of the job may be altered without notice. 

Interstate Waste Services 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.  

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. 

Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the greater New York, New Jersey and Connecticut markets with a rail-served landfill in Ohio!  IWS is committed to delivering high-quality waste, recycling and environmental services, while prioritizing the safety of our employees, customers and communities. We cater to a diverse range of industrial, medical and commercial/residential customers. 

Founded in 1998, IWS has grown over the years through acquisitions, many of which were family-owned businesses that remain a part of our team today. We’re proud to combine the resources of a large company with the values and care of a family-run business. 

Our Yellow Iron Diesel Mechanics perform inspection, diagnosis, preventative maintenance, and repair of electrical, hydraulic, suspension, brake and air systems on vehicles and equipment, primarily including yellow iron machinery, diesel heavy trucks and engines. The Technician or Mechanic is not only responsible for understanding maintenance and breakdown needs and initiating/ assigning necessary repairs, but also must be able to operate the machinery being repaired. At times, the Technician may be on call and required to assist with emergency breakdowns.

• Maintains advanced knowledge to diagnose and repair mechanical problems on heavy equipment (heavy equipment includes but not limited to: yellow iron machinery, tractor trailers, forklifts, and other diesel trucks)
• Performs repairs and assigned preventative maintenance services.
• Estimates time and material cost on vehicle repairs and requisition of new parts.
• Conduct safety checks on vehicles.
• Completes required paperwork utilizing fleet maintenance software program associated with repairing vehicles, documenting part usage, and accounting for repair time.
• Reviews, completes, or assigns repairs identified on Driver Vehicle Inspection Reports.
• Maintain a clean, safe work area in compliance with Company safety protocols and OSHA standards.
• This position will have no direct reports, however they will work in collaboration with the other yellow iron diesel mechanic on staff, although on different shifts.
• Assists Sr. Technicians in the completion of project work.

Work Environment

• Potentially hazardous work environment with many moving parts and machinery; must be alert of surroundings at all times.
• Only during breakdowns will this position be required to enter transfer station loading/ dumping area.
• The Yellow Iron Diesel Technician/Mechanic may be required to lift up to 50 pounds. Frequent squatting and standing is required.

Requirements

• Applicants must be at least 18 years of age and legally eligible to work in the United States.
• A valid driver’s license is required. CDL a plus.
• At least 5 years of experience in job duties.
• Sanitation or construction industry experience a plus.
• Computer diagnostic experience as diesel technician a plus.
• Experience with troubleshooting/repairing DPF systems diagnostic software such as Premium Tech Tool (Mack), Allison transmission, Cummins, CAT, Peterbilt, and Paccar.
• Working knowledge of applicable DOT and OSHA standards and regulations.
• Must be able to speak and read English well enough to converse with colleagues, drivers and dispatch, and be able to make legible entries on reports and records.
• Must be able to meet the physical and safety requirements of the position.
• Must be able to provide own tools

This job description is intended to be an accurate representation of the general functions of the job, rather than exhaustive list of duties, responsibilities, or experience. Other duties may be assigned, requested, or required. Aspects of the job may be altered without notice. 

Interstate Waste Services 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.  

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. 

Schedule: Monday - Friday 8:00 AM - 6:00 PM, Occassional Satuday 6:00 AM - 2:00 PM

Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State, New York City, Connecticut, with a landfill located in Ohio, where we also own and operate a state-of-the-art rail-served landfill. We cater to a diverse range of residential, industrial and commercial customers. Our mission has always been to provide our customers with the highest quality waste, recycling and environmental services, while keeping focus on employee, customer and environmental safety. 

What makes our company culture unique is we have mastered the ability to balance the standards of a large corporate company while maintaining our small business family style culture. 

Our Yellow Iron Diesel Technicians/Mechanics perform inspection, diagnosis, preventative maintenance, and repair of electrical, hydraulic, suspension, brake and air systems on vehicles and equipment, primarily including yellow iron machinery, diesel heavy trucks and engines. The Technician or Mechanic is not only responsible for understanding maintenance and breakdown needs and initiating/ assigning necessary repairs, but also must be able to operate the machinery being repaired. At times, the Technician may be on call and required to assist with emergency breakdowns.

• Maintains advanced knowledge to diagnose and repair mechanical problems on heavy equipment (heavy equipment includes but not limited to: yellow iron machinery, tractor trailers, forklifts, and other diesel trucks)
• Performs repairs and assigned preventative maintenance services.
• Estimates time and material cost on vehicle repairs and requisition of new parts.
• Conduct safety checks on vehicles.
• Completes required paperwork utilizing fleet maintenance software program associated with repairing vehicles, documenting part usage, and accounting for repair time.
• Reviews, completes, or assigns repairs identified on Driver Vehicle Inspection Reports.
• Maintain a clean, safe work area in compliance with Company safety protocols and OSHA standards.
• This position will have no direct reports, however they will work in collaboration with the other yellow iron diesel mechanic on staff, although on different shifts.
• Assists Sr. Technicians in the completion of project work.

• Applicants must be at least 18 years of age and legally eligible to work in the United States.
• A valid driver’s license is required. CDL a plus.
• At least 5 years of experience in job duties.
• Sanitation or construction industry experience a plus.
• Computer diagnostic experience as diesel technician a plus.
• Experience with troubleshooting/repairing DPF systems diagnostic software such as Premium Tech Tool (Mack), Allison transmission, Cummins, CAT, Peterbilt, and Paccar.
• Working knowledge of applicable DOT and OSHA standards and regulations.
• Must be able to speak and read English well enough to converse with colleagues, drivers and dispatch, and be able to make legible entries on reports and records.
• Must be able to meet the physical and safety requirements of the position.
• Must be able to provide own tools

Work Environment

• We are continuously investing in equipment, and many of our trucks are less than 2 years old.
• Potentially hazardous work environment with many moving parts and machinery; must always be alert of surroundings.
• Only during breakdowns will this position be required to enter transfer station loading/ dumping area.
• Personal Protective Equipment (PPE) will be provided.
• The Yellow Iron Diesel Technician/Mechanic may be required to lift upwards to 50 pounds. Frequent squatting and standing are required.

This job description is intended to be an accurate representation of the general functions of the job, rather than exhaustive list of duties, responsibilities, or experience. Other duties may be assigned, requested, or required. Aspects of the job may be altered without notice.

Interstate Waste Services 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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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 Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.

Key Responsibilities

• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.

• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.

• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.

• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.

• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.

• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.

• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.

• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.

• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.

• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.

• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.

Leadership & People Management

• Mentor and coach team members to continually develop and enhance their skills.

• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.

• Foster a culture of accountability with progressive empowerment and ownership.

• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.

• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.

• Experience hosting and managing regulatory and client inspections.

• Strong understanding of Quality Systems requirements and regulatory expectations.

• Excellent oral and written communication, listening, and problem-solving skills.

• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.

• Strong organizational awareness with significant experience working cross-functionally.

• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.

• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.

• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.

• Proven experience influencing stakeholders across a broad spectrum of GxP topics.

• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.

Preferred Qualifications

• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.

• Experience with cell and gene therapy manufacturing in clinical or commercial environments.

• Strong track record managing quality systems and training programs.

• Expertise in aseptic manufacturing processes.

• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.

• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.

Required Degree

• B.S. in a relevant scientific discipline (advanced degree preferred).

Physical Requirements

Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.

Company Description

CCL Industries is a global leader in specialty packaging & Labeling solutions, offering a wide range of innovative products. These include extruded and laminated plastic tubes, folded instructional leaflets, and precision-printed components with LED displays, among others. CCL also operates Avery, the world's largest supplier of labels, specialty media, and software for short-run digital printing. Additionally, the company includes CCL Container, a top producer of aluminum aerosol cans and bottles for consumer packaged goods in the United States. With its diversified product portfolio, CCL serves a variety of end-use markets worldwide.

Role Description

This is a full-time on-site role for a Production Supervisor - Labeling & Packaging, based in Hightstown, NJ. The Production Supervisor will oversee and coordinate labeling and packaging operations to ensure efficient workflows. Responsibilities include managing production schedules, overseeing production planning, and ensuring quality standards are consistently met. The role involves directing and supporting production staff, addressing any operational issues, and adhering to safety protocols within the facility.

Essential Functions

• Oversees daily production operations to ensure scheduled jobs are completed safely, accurately, and on time.
• Leads, trains, and supports production staff, promoting teamwork, efficiency, and adherence to company policies.
• Monitors production equipment and workflows to maintain quality standards and minimize downtime.
• Ensures compliance with safety regulations, cGMP, and operational procedures at all times.
• Coordinates material needs, machine setups, and job changeovers to maintain continuous production flow.
• Troubleshoots production issues and implements corrective actions to improve performance and reduce waste.
• Tracks and reports production metrics, including output, quality, waste, and labor utilization.
• Communicates effectively with leadership, quality, logistics, and other departments to support overall plant operations.
• Supports continuous improvement initiatives, including Lean, 5S, and process optimization efforts.

Qualifications

• Flexographic printing experience is strongly preferred for this role.
• Strong Supervisory Skills, including team leadership and employee development
• Experience in Production Planning and Production Schedules to manage efficient workflows
• Competency in Production Management practices to ensure operational efficiency and quality
• Excellent Communication skills, including the ability to provide clear direction and foster collaboration
• Knowledge of safety procedures and guidelines in a packaging or manufacturing environment
• Problem-solving and organizational skills to manage multiple priorities effectively
• Previous experience in labeling or packaging industries is a plus
• Associate or Bachelor’s degree in Engineering, Management, or a related field is preferred

Skills/Aptitudes:

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. 
• Ability to write routine reports and correspondence.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
• Skill in operating computer systems with a proficiency in Word/Excel and ability to learn AS400.
• Ability to speak effectively and present information in one-on-one and small group situations to customers, vendors, and other employees of the organization.
• Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.

Compensation: $80,000 – $93,000 per year

Schedule: Monday-Friday: 2nd shift (3:00pm-11:00pm) or 3rd shift (11:00pm-7:00am)

Working Conditions/Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and ink vapors. The noise level is usually loud.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects or operate pressroom equipment and tools, reach with hands and arms, talk and hear, and lift at least 50 lbs.

Specific vision abilities required by this job include close vision, distance vision, color-vision, peripheral vision, depth perception, and ability to adjust focus.

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.

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.

About Cygnus Professionals, Inc.

Cygnus is a Princeton, NJ-headquartered global Business IT consulting and software Services firm with offices in the USA and Asia. Cygnus offers and enables innovation and helps our clients accelerate time to market & grow their business. Over 15 years, we have taken great pride in continuing our deep relationships with our clients.

For further information about CYGNUS, please visit our website Title: Data Architect

Location: Princeton, New Jersey – Onsite

W2 Contract

Job Summary

We are seeking an experienced Data Architect to design, build, and maintain scalable data architecture solutions supporting enterprise analytics, data integration, and digital transformation initiatives. The ideal candidate will work closely with business stakeholders, data engineers, and application teams to design robust data models, data pipelines, and enterprise data platforms that support advanced analytics and reporting.

Key Responsibilities

• Design and implement enterprise data architecture frameworks and best practices.
• Develop logical and physical data models for enterprise data platforms.
• Architect data lakes, data warehouses, and data integration solutions across cloud and on-prem environments.
• Collaborate with data engineers and application teams to build scalable data pipelines and ETL/ELT processes.
• Ensure data governance, data quality, security, and compliance standards are implemented across the data ecosystem.
• Evaluate and recommend data technologies, tools, and frameworks aligned with enterprise strategy.
• Provide architectural guidance for cloud-based data platforms (AWS/Azure/GCP).
• Optimize performance for large-scale data processing and analytics workloads.
• Support business intelligence, reporting, and advanced analytics initiatives.

Required Qualifications

• 10+ years of experience in data architecture, data engineering, or enterprise data management.
• Strong experience with data modeling (conceptual, logical, physical).
• Expertise with data warehouse and data lake architectures.
• Hands-on experience with ETL/ELT tools and data integration platforms.
• Experience with SQL and large-scale data platforms (Snowflake, Redshift, BigQuery, etc.).
• Experience working with cloud data platforms (AWS, Azure, or GCP).
• Strong understanding of data governance, data quality, and metadata management.
• Experience with big data technologies (Spark, Hadoop, Kafka) is a plus.

Preferred Skills

• Experience in Healthcare, Pharmaceutical, or Life Sciences domain.
• Knowledge of Master Data Management (MDM) and data catalog tools.
• Familiarity with BI tools such as Tableau, Power BI, or Looker.
• Strong communication skills to interact with business and technical teams.

Education

• Bachelor’s or Master’s degree in Computer Science, Information Systems, Data Science, or related field.

Cygnus Belief

We believe in our commitment to diversity & inclusion.

Equal Employment Opportunity Statement

Cygnus is an Equal Opportunity Employer. We ensure that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.

All our employment decisions are taken without looking into age, race, creed, color, religion, sex, nationality, disability status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other aspects of employment protected by federal, state, or local law. Applicants for employment in the US must have work authorization.