Engineering Structures Journal Jobs in Dayton, NJ
76 positions found — Page 2
Overview
The position will be responsible for day-to-day accounting activities for operations to help ensure that the books are closed on time, in accordance with GAAP, and without material misstatement.
Responsibilities:
- Responsible for accounting, reporting, and analysis.
- Complete monthly accounting close, including journal entry preparation and balance sheet reconciliations.
- Work closely with the plants, legal, asset management, etc., to understand various operational issues and related accounting implications.
- Coordinating payments with Treasury and accounts payable team members.
- Experience in a fast-paced environment, including the ability and experience to meet firm deadlines, including monthly close on a defined schedule.
- Assist with special projects as requested.
- Hybrid schedule, e.g., 4 days in the office, and the balance of the week is remote
Requirements:
- Bachelor's degree in accounting, business, or finance.
- Knowledge of general ledger and reporting software
- Proficient with Microsoft Office applications, particularly Excel, with knowledge of advanced features such as pivot tables and lookups.
- Experience in general financial accounting and reporting.
- Demonstrated ability to communicate with all levels of internal and external contacts
- Ability to work independently in a team-oriented culture in a fast-paced environment.
- Experience with SAP preferred.
- Pursuing or holds CPA, preferred.
- Prior experience in the energy industry or a similar commodity-based business is preferred.
- Proven analytical and problem-solving skills; demonstrated planning and organizing skills; ability to think strategically/long-term.
- Proficient with Microsoft Office applications.
- Attention to detail
- Strong time management skills applications
We are a diverse, passionate team spread across the US, Canada, Mexico, and Puerto Rico, committed to growth, learning, and creating opportunities for each other.
At Turtle, every day is a chance to make a real difference, solve complex challenges, and push the boundaries of what’s possible.
We believe in fostering an environment that inspires collaboration and sparks creativity, where employees are empowered to contribute to our mission and shape the future of the industry.
If you're looking for a fast-paced, dynamic career where your ideas are valued and your growth is prioritized, Turtle is the place for you.
Join us and be a part of a company that’s making waves and empowering its people to do extraordinary things every single day! About the Role The Will Call Supervisor oversees daily will call and expedited order operations, ensuring orders are processed accurately, efficiently, and on schedule.
Responsibilities include completing all will call orders, capturing proof of delivery (POD) documentation, and coordinating expedited requests such as Turtle Express and courier pickups.
Additionally, this position manages the returns team and assists the AM Warehouse Supervisor and Manager in morning warehouse operations, maintaining a safe and organized work environment, enforcing safety policies, and supporting warehouse productivity.
Supervisors are cross trained in multiple operational areas and may provide coverage as needed to ensure efficient daily operations.
What You'll Do: Ensure all employees have required PPE and perform tasks safely.
Oversee daily will call operations (order picking, staging, and completion).
Properly capture and record will call proof of delivery (POD) documentation.
Coordinate expedited order requests (Turtle Express, courier pickups, priority orders).
Accurately receive all PO pickups into the system in a timely manner.
Sort relay orders to appropriate delivery routes and ensure paperwork is given to dispatch.
Supervise returns team to process returns accurately and promptly.
Support AM warehouse functions: replenishments, receipts, transfers, and putaways.
Inspect forklifts and powered industrial equipment before each shift.
Conduct toolbox and safety meetings with will call and returns teams as needed.
Complete daily operational checklists and document all will call and return activities.
Learn and enforce company agreements and working rules.
Complete near miss and/or accident reports as required.
Conduct or oversee new hire training in will call and returns areas.
Work with Quality and Safety Manager on training targets, including ADP requirements.
Coach employees to prevent repeated errors and improve performance.
Assist with warehouse labor as needed (picking, packing, other tasks).
Be cross-trained and provide coverage in multiple operational areas to ensure smooth daily distribution center operations.
What You'll Bring High school diploma or equivalent required.
Minimum of 3–5 years of warehouse or distribution center experience.
Previous experience in a lead, coordinator, or supervisory role preferred.
Strong understanding of warehouse operations including will call, receiving, returns, and order fulfillment processes.
Experience working with warehouse management systems (WMS), RF scanners, and inventory systems.
Ability to prioritize multiple tasks and manage expedited and time-sensitive orders.
Strong communication and leadership skills with the ability to coach and guide team members.
Working knowledge of warehouse safety standards and OSHA guidelines.
Ability to operate or become certified to operate forklifts and other powered industrial equipment.
Ability to lift 50 lbs.
and work in a fast-paced warehouse environment.
Proficiency with basic computer systems and Microsoft Office applications.
What We Offer We offer a competitive benefits package that includes: 401(k) plan Health insurance Dental insurance Vision insurance Life insurance Paid holidays Vacation Employee negotiated discounts Who We Are Founded in 1923, Turtle is a fourth-generation, family-owned, and three-generation women-owned business, and one of the nation’s largest independent electrical and industrial distributors.
Headquartered in Clark, NJ, our Electrical Distribution division operates 14 branches spanning from coast to coast.
It is a significant force in the engineering and procurement of power distribution, automation, lighting, and energy projects, offering integrated services for the industrial and construction markets.
Turtle Integrated provides on-site MRO procurement, cost-saving, and spend analytics across the US and in Canada, Puerto Rico, and Mexico.
What To Do Next You can begin by filling out our application online.
If you want to learn more about Turtle, please visit our website or our LinkedIn: @Turtle.
Turtle is proud to be is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, marital status, military or veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
Organize, train and oversee technical staff in order to implement established maintenance, inspection and operational procedures. Must have proven skills in problem-solving and team building. Be able to schedule work, repair, and maintain machines, equipment and facilities to ensure safe, reliable, and consistent operation according to the manufacturer’s requirements.
Responsibilities:
.
Qualifications:Duties and Responsibilities:
Must be knowledgeable and have basic understanding of mechanical, hydraulic and pneumatic systems including (but not limited to) the following areas:
- Manage union team members and oversee various jobs and projects.
• Monitor communication methods for additional work assignments, upcoming events, and internal communications.
• Ability to understand mechanical, hydraulic, and pneumatic drawings.
• Understanding of Building construction plans.
• Identify suppliers for replacement parts, obtain competitive bids, and enter purchase requisitions.
• Use test data and electrical schematics to troubleshoot malfunctioning equipment.
• Make recommendations regarding the need for modification to maintenance procedures, test procedures, instrumentation or setup based upon test results and machine operational performance.
• Work in co-operation with engineering, technical and management or outside personnel.
• Maintain detailed maintenance records in order to perform effective preventive maintenance.
• Maintain good Maintenance standards to ensure buildings, grounds and attractions are safe and visually in compliance.
• Have the ability to plan, organize and train a maintenance team for a large Theme park, Safari, and waterpark.
• Must have the ability to train safety, OSHA and protocol information to large groups and document the trainings.
• Must possess the ability to stand for long periods of time, climb stairs and ladders repeatedly, bend, stoop, twist, crawl, kneel, push, pull, and work overhead using both hands.
Responsibilities: .
Qualifications: Duties and Responsibilities:
Must be knowledgeable and have basic understanding of mechanical, hydraulic and pneumatic systems including (but not limited to) the following areas:
~ Manage union team members and oversee various jobs and projects. • Monitor communication methods for additional work assignments, upcoming events, and internal communications. • Ability to understand mechanical, hydraulic, and pneumatic drawings. • Understanding of Building construction plans. • Identify suppliers for replacement parts, obtain competitive bids, and enter purchase requisitions. • Use test data and electrical schematics to troubleshoot malfunctioning equipment. • Make recommendations regarding the need for modification to maintenance procedures, test procedures, instrumentation or setup based upon test results and machine operational performance. • Work in co-operation with engineering, technical and management or outside personnel. • Maintain detailed maintenance records in order to perform effective preventive maintenance. • Maintain good Maintenance standards to ensure buildings, grounds and attractions are safe and visually in compliance. • Have the ability to plan, organize and train a maintenance team for a large Theme park, Safari, and waterpark. • Must have the ability to train safety, OSHA and protocol information to large groups and document the trainings. • Must possess the ability to stand for long periods of time, climb stairs and ladders repeatedly, bend, stoop, twist, crawl, kneel, push, pull, and work overhead using both hands.
Responsibilities: .
Qualifications: Duties and Responsibilities:
Must be knowledgeable and have basic understanding of mechanical, hydraulic and pneumatic systems including (but not limited to) the following areas:
~ Manage union team members and oversee various jobs and projects. • Monitor communication methods for additional work assignments, upcoming events, and internal communications. • Ability to understand mechanical, hydraulic, and pneumatic drawings. • Understanding of Building construction plans. • Identify suppliers for replacement parts, obtain competitive bids, and enter purchase requisitions. • Use test data and electrical schematics to troubleshoot malfunctioning equipment. • Make recommendations regarding the need for modification to maintenance procedures, test procedures, instrumentation or setup based upon test results and machine operational performance. • Work in co-operation with engineering, technical and management or outside personnel. • Maintain detailed maintenance records in order to perform effective preventive maintenance. • Maintain good Maintenance standards to ensure buildings, grounds and attractions are safe and visually in compliance. • Have the ability to plan, organize and train a maintenance team for a large Theme park, Safari, and waterpark. • Must have the ability to train safety, OSHA and protocol information to large groups and document the trainings. • Must possess the ability to stand for long periods of time, climb stairs and ladders repeatedly, bend, stoop, twist, crawl, kneel, push, pull, and work overhead using both hands.
Overview
The Site Quality Manager is responsible for leading the quality function at their site and developing, implementing, and continuously improving the Humanscale Business System which exceeds customer expectations, satisfies regulatory requirements, improves operational efficiency, and reduces the cost of poor quality.
Essential Functions
- Customer Focus and Continuous Improvement
- Promote a quality culture and customer focused approach
- Capture the Voice of the Customer through customer feedback to enable development and value chain to improve design and execution
- Drive timely and effective resolution of customer issues
- Leadership
- Lead the Quality Assurance, Quality Control, and Quality Testing functions within the site
- Supervise workers engaged in the inspection and testing of activities to ensure efficient productivity and high technical integrity
- Manage the performance of the team through key performance metrics. Develop team to continuously improve performance and results
- Design, develop, and implement quality control training programs
- Conduct or arrange periodic training sessions to keep team members informed on proper procedures and methods
- Operations
- Establish and deploy site Quality objectives in line with Global Quality objectives
- Analyze and communicate the adequacy and effectiveness of the Humanscale Business System through performance metrics
- Coordinate and participate in Material Review Board (MRB) meetings
- Lead and participate in root cause analysis
- Drive effective corrective actions to prevent recurrence of non-conformances utilizing A3/SPS, 8D, and similar tools
- Execute cost of poor quality reduction measures to drive company savings
- Ensure compliance with customer, industry, and regulatory requirements
- Improve and error-proof business processes utilizing SS / Lean methodologies
- Develop, implement, and maintain quality specifications and standards for all raw materials, components, and finished goods
- Create, document, and implement inspection criteria and procedures
- Quality System
- Lead site Quality Performance Reviews
- Lead internal audits and drive timely closure of findings
- Apply total quality management tools and approaches to analytical and reporting processes
Qualification
- Bachelor’s degree from an Engineering discipline (Mechanical preferred)
- Minimum of 3-5 years of experience in Quality Control in a manufacturing environment
- Minimum of 2 years of management experience
- Knowledge of Quality Management Systems, especially ISO 9000
- Knowledge of ERP systems, especially Oracle and Infor, is highly desirable
- Lean Manufacturing experience a plus
- Experience with developing/documenting procedures
- Excellent interpersonal skills to lead the quality function to a higher level of performance
- Demonstrated customer focus, with drive and determination to improve quality performance
- Able to direct and lead others to produce desired results
- Demonstrated analytical skills, combining multiple data sources to create quality insights that drive improvement.
- Demonstrates attention to detail and thrives in a team environment.
- Exercise initiative, achievement, and independent judgment
WHAT WE OFFER:
- Competitive base
- Medical Benefits (Medical, Dental, Vision)
- HSA, FSA, Commuter Benefits
- Medical Discounts
- Ancillary Benefits
- Accident, Critical Illness, Hospital Insurance
- Voluntary, Spouse, and Child Life Insurance
- Pet Insurance
- Employee Discount Programs
- 401k matching
- Paid time off (including 15 PTO days and 11 holidays)
Salary Range: $86,829 - $126, 649
Please note that the salary information is a general guideline. Humanscale considers other factors such as (but not limited to) scope and responsibilities of the position, candidate’s work experience, education/training, key skills, internal peer equity, as well as market location and business considerations when extending an offer.
Company Overview
Humanscale is the premier designer and manufacturer of ergonomic products that improve health and comfort at work. We have a focus on sustainability with 70% of our products currently certified as having a Net Positive impact on the environment. Our award-winning office products – seating, sit/stand desks, technology support and lighting – have led the industry in performance and simplicity for over 40 years.
Humanscale is an Equal Opportunity Employer (Disabled/Veteran)
Scam Notice: Please be aware that there are individuals and organizations that may attempt to scam job seekers by offering fraudulent employment opportunities in the name of Humanscale. These scams may involve fake job postings, unsolicited emails, or messages claiming to be from our recruiters or hiring managers. Humanscale will never ask for any personal account information, such credit card details or bank account numbers, during the recruitment process.
In this role, you will report to the Site Manager and will work closely with the Avantor's Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.
Location: Somerset, NJ
Shift: 8 am-4:30 pm (may change based on customer needs)
Hourly Rate: $23.00 - $25.00
Benefits:
Health and Wellness: Medical, Dental, Vision, and Wellness programs
Time Off: Paid Time Off (PTO), Company-paid holidays, Choice holidays, etc.
Financial Well Being: Spending Accounts: Flexible Spending Account (FSA), Health Savings Accounts (HSA), commuter benefits, 401(k), tuition assistance, employee stock purchase plan discount
Added Protection Coverage: To include critical illness, hospital indemnity, accident, legal, identity theft protection, pet, auto, and home insurance
Recognition: Celebrate your peers and earn points to redeem for gifts and products
What we're looking for
Education:
High school diploma required; Associate's or Bachelor's degree in Supply Chain, Logistics, Life Sciences, or related field preferred.
Experience:
1-2 years in procurement, inventory management, or lab operations required.
SAP, MS Office Suite (Excel, Access), and digital procurement platforms preferred.
Collaboration Tool: Microsoft Teams experience preferred
Formal training in problem-solving methodologies is preferred.
Familiarity with FDA, CGMP, and ISO standards.
Strong understanding of lab operations and material workflows.
Ability to independently solve complex problems using operational insights.
Excellent organizational and multitasking skills.
Effective communicator with strong interpersonal and negotiation abilities.
Proficient in data analysis and reporting,
Proficiency with MS Office Suite (Expert-level skills in Excel)
SAP experience is highly desirable.
Knowledge of contracts and supplier management best practices.
Comfortable working in highly regulated environments.
How you will thrive and create an impact
Avantor's Advanced Laboratory Services team is a crucial part of the Avantor Services group serving over 500 customers in biopharma, pharmaceutical, educational, industrial, and high-tech industries with customizable, flexible solutions and end-to-end laboratory operations support.
As an Onsite Procurement Specialist/Buyer, you'll be embedded at customer facilities to ensure the seamless coordination of inventory and material operations. This role supports laboratory and production environments by managing sourcing, procurement, and logistics of essential materials, including consumables, chemicals, solvents, and reagents. You'll be the operational backbone of our onsite services, helping our customers maintain efficiency, compliance, and scientific progress. In this role, you will:
Coordinate and streamline workflows related to inventory and material management.
Support procurement and planning functions, ensuring timely and compliant delivery of materials.
Maintain strong relationships with vendors and internal departments to optimize cost, quality, and delivery timelines.
Ensure alignment with regulatory standards, including FDA, CGMP, and ISO9001.
Collaborate with Avantor's broader service and sourcing teams to deliver integrated solutions.
Source, procure, and coordinate delivery of critical lab and production materials.
Manage inventory levels, reorder points, and replenishment cycles using Avantor and customer systems.
Assist in supplier qualification, contract interpretation, and compliance documentation.
Support emergency deliveries and installation of materials.
Maintain standing orders and manage engineering change notifications.
Provide reporting on material planning, open orders, and performance metrics.
Resolve non-conformance issues and document supplier corrective actions.
Facilitate audit support and vendor engagement activities.
Collect, document, and report operational data and observations.
Maintain >95% inventory accuracy across managed categories.
Achieve an on-time delivery rate of >98% for critical materials.
Ensure 100% compliance with regulatory and safety standards.
Deliver monthly reports on inventory levels, supplier performance, and cost savings.
Perform other duties as assigned.
Resolve procurement issues within 48 hours of escalation.
Maintain positive customer satisfaction scores through responsive service and communication.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Know Your Rights poster.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
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.
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.