Engineering Jobs in Dayton, NJ

About Made Scientific

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

Position Summary

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

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

Key Responsibilities

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

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

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

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

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

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

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

• Perform other duties as assigned.

Required Qualifications

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

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

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

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

• Excellent communication, leadership, and organizational skills.

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

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

Preferred Qualifications

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

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

Physical Requirements

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

• Regular, punctual attendance is required.

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

• Must be able to lift up to 25 lbs.

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

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

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

Work Schedule

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

About Made Scientific

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

Position Summary

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

Key Responsibilities

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

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

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

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

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

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

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

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

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

• Support process development activities during technology transfer.

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

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

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

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

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

• Perform other duties as assigned.

Required Qualifications

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

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

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

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

• Excellent collaboration, communication, and interpersonal skills.

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

Preferred Qualifications

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

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

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

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

Physical Requirements

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

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

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

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

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

Work Schedule

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

*Duration: 7 months contract

Job Description:

• The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality Analyst serves as a single point of contact to the Sr. Manager, Janssen Commercial Quality and Supply Chain partners on compliance related matters and is the liaison with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance related issues. The Quality Analyst identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Analyst implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

Responsibilities:

• Quality and compliance product receiving process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP
• Monitoring and following Quarantine/Hold/Stop-Ship/Recall processes and notices
• Product refusals process activities, including, but not limited to inspection and disposition
• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues
• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems
• Responsible for adherence to the Records Management and Retention processes
• Responsible for adhering to the Training process
• Supporting internal and external audits
• Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally
• Provide quality and compliance oversight for execution of Protocols
• Notify/escalate critical quality issues to management in a timely manner
• Provide data/information/metrics to management for Quality System Management Reviews
• Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner
• Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives
• Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.
• Perform gap assessments in local procedures to client Global Standards, Business processes, and External Standards
• Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-up
• Ensures compliance and remaining current with local, state, federal, and international regulations and standards
• Evaluate the overall compliance risk and recommending corrective actions and tracking progress
• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs
• Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labeling activities
• Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities
• Monitor and review temperature data for the Distribution Center and ancillary areas
• Supports 24/7 operations of the Distribution Center
• Operate in a team-based environment with minimum supervision
• Provide training to new hires (FTEs) and/or Contractors
• Interface collaboratively with other business partners and stakeholders

Experience:

• A minimum of 2 years of experience in a highly regulated industry is required.
• Quality and Compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
• Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.
• Experience with Warehouse Management Systems and SAP is preferred.
• Experience with Quality Management Systems such as COMET is preferred.
• Proficiency in organizational and project management skills is preferred.
• Experience with Temperature Control is preferred.
• This position may require up to a 10% of domestic travel.
• Location can be Shepherdsville, KY or Somerset, NJ

Skills:

• Quality Management system

Education:

• A minimum of bachelor’s degree in an Engineering, Life Science, and Technical scientific or related discipline is preferred. In absence of a bachelor’s degree, special consideration would be considered for individuals who have related and background experience.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Azhar

Email:

Internal Id: 26-04181

Job Title: Bid Manager / Project Controller

Location: Piscataway, New Jersey

Salary: Up to $110,000 (based on experience)

Full-Time | Competitive Benefits

Join Our Team in Piscataway, NJ

We are seeking a detail-oriented and strategic Bid Manager / Project Controller to join our growing team in Piscataway - the right candidate will be incredibly detail oriented. This role is ideal for a professional who excels at managing bids, overseeing project financials, and ensuring operational excellence from proposal through execution.

With a competitive salary of up to $110,000, this is an excellent opportunity to play a critical role in driving project success and business growth.

Key Responsibilities

• Excellent and proven attention to detail. The rest can be taught!
• Lead and coordinate the end-to-end bid and proposal process
• Prepare cost estimates, pricing models, and financial analyses
• Develop and maintain project budgets, forecasts, and cost controls
• Monitor project performance against financial and operational targets
• Identify risks and implement mitigation strategies
• Collaborate with engineering, operations, finance, and leadership teams
• Support contract negotiations and ensure compliance with client requirements
• Produce detailed reporting for senior management and stakeholders

Qualifications

• Bachelor’s degree in Business, Finance, Engineering, or related field
• 3+ years of experience in bid management, project controls, or financial project oversight
• Strong financial acumen and analytical skills
• Experience with budgeting, forecasting, and cost tracking
• Excellent organizational and communication skills
• Proficiency in Excel and project management software
• PMP or similar certification (preferred but not required)

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

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Location: 160 Princeton Hightstown Road, East Windsor NJ 08520

Rate of Pay: Rate of pay: $84,469 - $103,320 per year

Job Overview

The Warehouse Management Systems (WMS) Analyst serves as the on-site liaison between the operations management team and the Information Technology team, and plays a role of a super user in the utilization of the system. They would be responsible for day-to-day system maintenance and troubleshooting. First point of contact for assistance, questions, issues, training others, etc. at the operations level. Work with Operations teams, IT, and Engineering groups to ensure optimal configurations for WMS conversions, enhancements, and new business requirements.

Job Responsibilities and Essential Duties

• 
  
• Conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively. Includes program analysts and management consultants.
  
• Serves as the on-site liaison between the Operations Management and Information Technology teams, acting as a super user of the Warehouse Management System (WMS).
  
• Responsible for day-to-day system maintenance and troubleshooting, and functions as the first point of contact for operational-level assistance, including user questions, issues, and training. Collaborates with Operations, IT, and Engineering teams to ensure optimal system configurations for WMS conversions, enhancements, and new business requirements.
  
  

Minimum Requirements

• 
  
• Bachelor's degree in a STEM field plus 3 years of experience in warehouse management systems, or related.
  
• A minimum of 3 years of related systems experience.
  

Required Knowledge, Skills, and Abilities

• 
  
• Requires skills and experience to involve: Expert-level knowledge of Blue Yonder WMS from an operational perspective, including data mining, issue investigation, system adjustments, and development of best practices.
  
• Hands-on experience managing warehouse zones, including movement paths, storage zones, pick zones, and count zones, to ensure efficient workflow and inventory accuracy.
  
• Proven ability to troubleshoot RF (radio frequency) issues, ensuring minimal disruption to daily operations. Expertise in barcode configuration and management, supporting accurate and efficient inbound, picking, and pack-out processes across multiple product lines.
  
• Strong background in waving processes and shortage resolution, critical to ensuring on-time order fulfillment.
  
• Experience testing within Blue Yonder WMS environments, following documentation best practices to ensure system reliability and consistency.
  
• Skilled in troubleshooting support requests related to WMS and integrated systems or interfaces.
  
• Experience developing and maintaining SOPs and site-specific process documentation to ensure consistent and efficient operations.
  
• Familiarity with shipping quality guidelines, and extensive experience in inventory management and quality control to ensure operational excellence.
  

Supervision/Management of Others:

• 
  
• The position does not supervise other employees
  

Internal and External Contacts/Relationships

• 
  
• Internal: Warehouse and Logistics team, Getinge employees
  
• External: Working relationships with external vendors, operations, and IT team members
  

Environmental/Safety/Physical Work Conditions

• 
  
• Ensures environmental consciousness and safe practices are exhibited in decisions
  
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
  
• May work extended hours during peak business cycles
  

Permissions

Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

At Getinge, we offer a comprehensive benefits package, which includes:
* Health, Dental, and Vision insurance benefits
* 401k plan with company match
* Paid Time Off
* Wellness initiative & Health Assistance Resources
* Life Insurance
* Short and Long Term Disability Benefits
* Health and Dependent Care Flexible Spending Accounts
* Commuter Benefits
* Parental and Caregiver Leave
* Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Who we are:

Atkore is forging a future where our employees, customers, suppliers, shareholders, and communities are building better together - a future focused on serving the customer and powering and protecting the world.

With a global network of manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions.

Who we are looking for:

We are currently looking for a BIM Technician to be based out of Tampa, FL reporting to the Drafting Manager. This person will be responsible for working with the project team to develop accurate and complete modeling drawing sets. The BIM Technician will ensure the integrity of project drawings while maintaining privileged information per the customer and company requirements.

What you'll do:

• 
  
• Accurately identify product specifications and understand of detail assemblies and their application for installation.
  
• Create or revise/update construction drawings, maintaining a tracking log of drawings.
  
• Review drawings for accuracy and scope of work, ensuring quality of final drawings.
  
• Collaborate with team and customers to ensure that projects are successfully completed, and best practices/technical issues are addressed.
  
• Run the multi trade coordination for clashes to assist project team with the design process.
  
• Conduct clash detection and visual walkthroughs using Navisworks Manage.
  
• Research ways to continuously improve our process including providing insight into new time saving methodologies and best practices.
  
• Manage, maintain, and update BIM Project documents.
  

What you'll bring:

• 
  
• Bachelor's (preferred) or Associates Degree in Architecture, Engineering, and Construction (AEC) related field with 1 to 3 years of industry experience.
  
• 1+ years' experience in 3D Revit or 3D AutoCAD.
  
• Technical certificates in Drafting and ED BIM Modeling training (preferred).
  
• Experience with Autodesk Revit, CAD, and BIM procedures (Preferred).
  
• Familiarity with Overhead coordination process including 3D Modeling utilizing Revit in project environment, Project As-builts and turnover for Facility management.
  
• Experience with Microsoft Office Suite, CAD and BIM systems including Autodesk AutoCAD, Revit Suite, BIM 360, Veo, Bluebeam, Word, Excel, and PowerPoint.
  

Within 3 months, you'll:

• 
  
• Complete the onboarding material and training on companies' products and drafting processes.
  
• Collecting information from multiple plans and incorporating them into a model which can be used to build structural support.
  
• Produce 2D shop drawings and 3D models projects with assistance of PM and BIM Designer.
  
• Complete Atkore Immersion process.
  

Within 6 months, you'll:

• 
  
• Communicate effectively with PM's and other team members in order to gather the information needed for each project.
  
• Develop strong knowledge of the companies' products and produce accurate designs based on each project needs.
  
• Assist with BIM Designer to coordination meeting and be part of BIM project development at different phases: modeling, cleaning clashes and producing shop drawings.
  

Within 12 months, you'll:

• 
  
• Produce structural models and drawings using Revit and manage coordination projects.
  
• Manipulate and develop CAD library components for AutoCAD and Revit or other related software.
  
• Independently handle BIM project from start to finish by assisting to BIM Coordination, performing clash detection, and resolving coordination issues.
  

Atkore is a recipient of a Great Place to Work certification and a Top Workplaces USA award! We're committed to creating an engaged and aligned workforce that drives collaborative culture. Our team strives for breakthrough results, stays focused on being standout leaders, and fully supports decisions of the Company. We consistently live the Atkore mission, strategic priorities, and behaviors, all in a way that's consistent with our core values. Together, we build strong leaders that continually endeavor to move us forward.

With a global network of manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions.

Join our team and align yourself with an industry leader!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Pay: $175K+ annually ($150K-$175K base + up to 20% performance bonus), and full benefits.

Location: Onsite 5 days (7a-4p) a week in Northern NJ

Client: Exceptionally successful national manufacturing brand

This is a confidential search for a hands-on Plant Manager to lead operations at:

A custom metal fabrication facility serving large-volume clients (very unique job shop with custom projects).

This facility specializes in sheet metal, tubing, and wire component fabrication, with capabilities including laser cutting, NC punching, brake forming, roll forming, TIG/MIG welding, spot welding, grinding, and in-house powder coating.

Job Summary

We are seeking a strategic, operationally strong manufacturing leader with deep experience in metal fabrication and a strong commitment to safety, quality, and continuous improvement. This role requires an accountable and results-driven professional who can lead teams, manage plant budgets, and drive operational efficiency in a fast-paced production environment.

The ideal candidate thrives on problem-solving, builds high-performing teams, and delivers operational excellence.

What You Will Do

• Direct and oversee daily plant operations including production, maintenance, quality control, inventory, and shipping/receiving
• Develop and implement strategies to improve productivity, reduce waste, optimize costs, and ensure on-time delivery
• Establish and monitor KPIs (scrap rates, downtime, safety metrics, throughput, etc.) and implement corrective actions
• Develop and manage plant budgets and capital expenditures
• Ensure compliance with federal, state, and local regulations including OSHA and workplace standards
• Drive Lean Manufacturing and continuous improvement initiatives
• Oversee preventive maintenance programs to ensure equipment reliability
• Lead, mentor, and develop management staff and production personnel
• Partner cross-functionally with Sales, Engineering, and Supply Chain to align plant performance with business goals
• Manage vendor and contractor relationships

What It Takes to Succeed

• Bachelor’s degree in Engineering, Manufacturing, Business, or related field (or equivalent experience)
• 7–10+ years of progressive leadership experience in manufacturing
• Strong experience in metal fabrication operations (machining, welding, forming, stamping, finishing)
• Demonstrated leadership and team development capability
• Knowledge of workplace safety and regulatory compliance

Preferred Experience

• Lean / Six Sigma certification
• ERP / MRP systems experience
• Experience in union environments (if applicable)

Work Environment

Manufacturing facility environment requiring regular presence on the production floor and adherence to PPE and safety standards.

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.