Engineering Jobs in Nj
243 positions found — Page 4
Kelly Science and Clinical FSP is currently seeking a R&D Support Specialist for a long-term engagement in the US with one of our clients in Summit, New Jersey. This is a hybrid position with 3 days on site weekly.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.
Position Overview:
The R&D Support Specialist role provides comprehensive administrative and operational support for the FEI/Skin Health team, focusing on supplier engagement, financial oversight, and talent acquisition processes. The ideal candidate will play a pivotal role in ensuring smooth procurement, accurate budget and invoice management, and effective coordination of onboarding and recruitment activities.
Key Responsibilities:
Supplier Approval and Onboarding Support:
- Coordinate with new suppliers to ensure timely completion of onboarding documents and compliance forms.
- Serve as a point of contact for suppliers during the approval process, answering queries and resolving issues.
- Maintain detailed records of supplier approvals and contracts – liaise with procurement as needed
Contracting and Purchase Order Management:
- Support the drafting, review, and processing of supplier contracts in collaboration with internal legal and procurement teams.
- Create and manage purchase orders, ensuring proper coding and authorization according to company policies.
- Monitor and follow up on outstanding contracts, PO status, and renewals.
Financial Administration and Tracking:
- Collaborate with team leads to maintain the FEI budget within financial management tools.
- Track quarterly invoicing, budget allocations, and identify discrepancies for prompt resolution.
- Prepare routine financial reports and dashboards for management review.
Talent Acquisition Support:
- Assist HR and hiring managers with job postings, resume screening, and interview scheduling.
- Organize panel interviews, coordinate feedback collection, and support onboarding logistics for new hires.
General Administrative Support:
- Handle ad-hoc tasks as needed, including meeting coordination, document preparation, and other operational requests.
Education Requirements:
- Bachelor's degree or applicable experience in lieu of degree (Business Administration, Finance, Human Resources, Supply Chain Management, or a related field)
- Advanced degree or relevant certifications (e.g., Certified Administrative Professional, SHRM-CP) a plus.
Experience Requirements:
- 2-4 years of experience in administrative support, procurement, contract management, or financial operations (preferably within a corporate or innovation environment).
- Experience with financial management software and procurement tools required; familiarity with PO processes, system management.
- Prior experience supporting HR/talent acquisition functions is an asset.
Desired Skills and Qualities:
- Excellent organizational and communication skills.
- High attention to detail and accuracy in financial documentation.
- Ability to manage multiple priorities and deadlines in a fast-paced environment.
- Proactive attitude – eager to act with urgency to resolve issues, maintain smooth processes, and provide top-tier support to all internal groups.
- Strong teamwork and problem-solving orientation.
- Proficiency in Microsoft Office Suite (Excel, Outlook, Word); experience with SharePoint and procurement platforms preferred.
SCOPE
The Welder / Fabricator is responsible for fabricating, repairing, and maintaining stainless steel equipment, structural components, and production machinery used in making product. This role supports production by ensuring all fabrication work meets food safety standards, sanitary design requirements, and plant maintenance needs. The Welder will weld, cut, and braze metal pieces and products by using flame-cutting and hand welding equipment.
Principle Accountabilities
- Support without hesitation General Plant Safety, Food Safety, Food Defense Initiatives and Good Manufacturing Practices with an understanding that these are absolutes and are Priority #1.
- Plans details of work order procedures; gathers required tools and materials based on instructions and specifications provided for the job.
- Fabricate, weld, and assemble stainless steel components used in bakery production equipment, conveyors, racks, and support structures.
- Perform TIG, MIG, and stick welding on stainless steel, mild steel, and aluminum materials.
- Repair damaged bakery equipment, including mixers, conveyors, ovens, pans, racks, and piping using cutting, burning, and welding techniques and equipment.
- Monitors the welding, burning, and fitting process to ensure parts are not overheated or damaged by warping, distortion, expansion, or shrinkage.
- Modify existing equipment to improve production efficiency or meet operational requirements.
- Prepares, assembles, and tacks weld parts and surfaces to be welded.
- Interpret blueprints, schematics, and fabrication drawings to complete projects accurately.
- Ensure all fabricated equipment meets food safety and sanitary welding standards for food manufacturing.
- Grind, polish, and finish welds to maintain hygienic surfaces suitable for food production.
- Work closely with the maintenance and engineering teams to support plant projects and equipment upgrades.
- Maintain welding equipment, tools, and fabrication shop area.
- Follow OSHA safety regulations and food safety policies (GMPs).
- Assist with installation of new bakery equipment and production lines.
- Notifies supervisor when faulty equipment or defective materials are discovered.
- Performs other related duties as assigned.
- Strong knowledge and experience in TIG welding as well as MIG welding.
- Thorough understanding of machines and tools used in welding including but not limited to designs, uses, maintenance and repair.
- Must have knowledge, experience and ability to weld steel, aluminum and stainless-steel using Arc, Tig, and Mig welding methods.
- Knowledge of metal cutting, grinding, and finishing
- Knowledge of fabrication layouts and measurements
- Basic understanding of design techniques, principles, and tools necessary for the precise production of technical plans, drawings, models and blueprints.
- Excellent ability to read and listen to assignments given in a variety of forms.
- Basic understanding of mathematics as it relates to welding assignments.
- Mechanical aptitude
- Ability to Problem-solve and troubleshoot equipment.
- High school diploma or GED required.
- Completion of a formal apprenticeship in welding or metal fabrication.
- Minimum 2–5 years welding/fabrication experience, preferably in food manufacturing, bakery, or industrial environments.
- Experience with stainless steel sanitary welding is strongly preferred.
- Ability to read and interpret technical drawings and blueprints.
- Knowledge of GMP, food safety, and sanitary design standards.
- Must be able to weld components that are vertical, flat, or overhead.
- Must have enough manual dexterity and stability as required for precision work.
- Must be able to see details at close range.
- Must be able to traverse facilities and machinery by climbing, balancing, lifting, walking, stooping, and carrying materials.
- May require working nights, weekends, or overtime depending on production needs.
Job Description: We are seeking a Sr Python Developers with strong Python skills, analytical thinking, and financial/risk experience to help with system design and implement the core modeling, scenario generation, and analytics components of this enterprise platform.
This role blends quantitative development and software engineering to build scalable tools used by Treasury, Market Risk, and senior decision-makers.
Key Responsibilities
Quantitative Modeling & Scenario Analytics
• Develop and implement using Python for balance sheet projections, interest rate risk (IRR), liquidity analytics, and scenario-driven stress testing.
• Support both regulatory scenarios (e.g., CCAR, SCB, liquidity stress) and ad hoc "what-if" analyses for Treasury and risk stakeholders.
• Build tools for scenario transformations, sensitivity calculations, curve construction, and quantitative stress analytics.
Platform & Data Engineering
• Design and maintain high performance Python modules that serve as the computational core of the scenario analysis framework.
• Proficient with Pandas, Numpy and other Quant libraries.
• Work with large datasets using SQL to integrate financial, balance sheet, and market inputs.
• Collaborate on the development of REST APIs that interface with scenario engines, model layers, and user applications.
Front-End & Workflow Integration
• Partner with UI developers to support React-based dashboards that present scenario results, visualizations, and analytics to business users.
Join a mission-driven environmental and engineering consulting firm that has been delivering innovative water resources and ecological restoration solutions. This Geotechnical Engineer / Technical Project Manager (PE Required) opportunity is based in Trenton or Sicklerville, NJ and offers the chance to work on meaningful projects such as stormwater management systems, dam removals, wetland restoration, coastal protection, and floodplain reconnections. If you're passionate about sustainable infrastructure and want to collaborate with a team that values environmental stewardship, creativity, and a positive work culture, this is an exciting place to grow your career.
Qualifications and responsibilities for this Geotechnical Engineer / Technical Project Manager position include:
- Bachelor's degree in Civil Engineering – Plan and execute subsurface investigations for land and water-based projects
- Professional Engineer (PE) license required – Perform geotechnical analyses including slope stability, seepage, bearing capacity, settlement, and liquefaction
- 6+ years of geotechnical engineering experience – Lead and manage geotechnical aspects of ecological restoration and water resources projects
- Experience with foundation and earth structure design – Analyze axial and lateral capacities of deep foundations and sheet pile systems
- Proficiency in AutoCAD and Civil 3D – Prepare geotechnical reports, drawings, and technical plans
- Strong written and verbal communication skills – Prepare proposals, technical reports, and present findings to clients and stakeholders
- Project management and time management skills – Oversee multiple projects including scheduling, coordination, and client interaction
- Leadership and mentoring ability – Train junior staff and provide geotechnical guidance across multiple practice areas
Salary: $95,000 - $125,000 per year, commensurate with experience.
Benefits: This full-time, permanent, direct-hire position offers great benefits including medical, dental, and vision insurance; a 401(k) plan with a 5% company match after three months and immediate vesting; paid vacation and personal time off; paid parental leave; and a hybrid work schedule with flexible core hours.
DAVRON is the leading Headhunter and Executive Search firm for Engineering, Architecture, Construction and Manufacturing professionals nationwide. Our recruiters have direct communication with hiring managers allowing us to get you in front of company decision makers. You also receive one-on-one interview preparation and insider coaching from staffing experts to help you every step of the way. We want to see you thrive in challenging work environments that bring you excitement and prosperity in your career!
Apply Now!
Are you ready to take the next step in your career and thrive in a challenging work environment? If so, apply today and let's see where this opportunity can take you!
GEOTECHNICAL ENGINEER | TECHNICAL PROJECT MANAGER | PROFESSIONAL ENGINEER (PE) | AUTOCAD | CIVIL 3D | GEOTECHNICAL ANALYSIS | DAM & LEVEE DESIGN | STORMWATER MANAGEMENT | WETLAND RESTORATION | FOUNDATION DESIGN | HYDROLOGIC & HYDRAULIC ANALYSIS | CONSTRUCTION OVERSIGHT
Cyber Security / Application Security Engineer with years of experience to lead enterprise security initiatives focused on application security, cloud security, and secure software development practices. The ideal candidate will drive security architecture, implement secure coding standards, and collaborate with engineering, DevOps, and infrastructure teams to ensure applications and platforms are protected against modern cyber threats.
This role requires deep expertise in application security, DevSecOps, cloud security, identity and access management, vulnerability management, and enterprise security architecture.
Key Responsibilities- Lead the design and implementation of enterprise application security architecture across modern cloud and on-premise environments.
- Integrate DevSecOps practices into CI/CD pipelines to ensure security is embedded throughout the software development lifecycle (SDLC).
- Perform secure code reviews, threat modeling, and vulnerability assessments to identify and mitigate security risks.
- Implement and manage SAST, DAST, SCA, and container security scanning tools across development pipelines.
- Design and enforce secure coding standards and security best practices for development teams.
- Architect and implement API security, microservices security, and container security for cloud-native applications.
- Lead identity and access management (IAM) implementations including SSO, RBAC, OAuth, OpenID Connect, and MFA.
- Manage cloud security controls across platforms such as AWS, Azure, or GCP, including cloud workload protection and security posture management.
- Conduct security risk assessments and penetration testing coordination to proactively identify vulnerabilities.
- Implement Zero Trust security principles, network segmentation, and secure access strategies.
- Work closely with DevOps, infrastructure, and engineering teams to remediate vulnerabilities and improve security posture.
- Monitor and respond to security incidents, threats, and vulnerabilities in collaboration with SOC teams.
- Ensure compliance with industry frameworks such as NIST, ISO 27001, SOC2, PCI-DSS, and CIS benchmarks.
- Provide technical leadership, mentoring, and guidance to security engineers and development teams.
- Develop security documentation, architecture diagrams, and risk mitigation strategies.
- Years of experience in Cyber Security, Application Security, or Security Engineering roles.
- Strong experience with Application Security (AppSec), secure SDLC, and DevSecOps practices.
- Hands-on experience with security scanning tools such as Checkmarx, Fortify, Veracode, Snyk, SonarQube, or Black Duck.
- Experience securing CI/CD pipelines using tools like Jenkins, GitHub, GitLab, or Azure DevOps.
- Deep knowledge of cloud security architectures (AWS, Azure, or GCP).
- Expertise in API security, container security, Kubernetes security, and microservices architecture.
- Experience with Identity & Access Management (IAM) technologies such as Okta, Azure AD, Ping, SailPoint, or ForgeRock.
- Strong understanding of OWASP Top 10, threat modeling, and vulnerability management.
- Experience with security monitoring tools, SIEM platforms (Splunk, QRadar), and incident response processes.
- Knowledge of network security concepts including firewalls, WAF, IDS/IPS, and Zero Trust architecture.
- Strong scripting or programming experience in Python, Java, or Bash for security automation.
- Experience implementing security compliance frameworks and governance controls.
- Security certifications such as CISSP, CISM, CEH, CSSLP, or CCSP.
- Experience leading enterprise security transformation or DevSecOps initiatives.
- Prior experience working in banking, healthcare, fintech, or large enterprise environments.
- Strong communication skills with the ability to work with cross-functional technical and leadership teams.
About Chiral Photonics
Chiral Photonics is a fast-growing photonics manufacturing company enabling next-generation optical connectivity. We specialize in high-precision fiber-optic components and assemblies that support advanced data center, AI, and communications infrastructure. As we scale production, we are building strong operational foundations rooted in standard work, quality, and continuous improvement.
Role Overview
The Operations Project Manager sits at the intersection of production planning and project/program management and plays a critical role in translating customer demand, business strategy, and operational capabilities into executable plans.
This role is responsible for:
- Production Forecasting and Capacity Planning (~40%) — Developing and maintaining production forecasts and capacity plans to ensure the organization has the right people, stations, and sequencing in place to meet customer demand.
- Portfolio Project Management (~40%) — Driving execution and alignment across a portfolio of operational, manufacturing, engineering, and business initiatives, ensuring priorities are clearly sequenced, resources are allocated appropriately, and projects progress according to plan.
- Additional Assignments (~20%) — Supporting the Operations and Production Directors with operational initiatives as needed. This may include, but is not limited to, reviewing and updating standard operating procedures (SOPs) across the product lifecycle, supporting process improvement efforts, and assisting with operational coordination.
This is a highly cross-functional role that partners closely with Production, Process Engineering, R&D, Sales, and Leadership. The ideal candidate is structured, analytical, and detail-oriented, and is comfortable bringing clarity, organization, and strong follow-through to complex operational challenges.
Key Responsibilities
1. Production Forecasting & Planning (~40%)
- Own and maintain production forecasts across standard, custom, and R&D orders.
- Translate demand into capacity and resource plans, including labor, stations/equipment, and shift planning.
- Maintain resource models by station, value stream, and operator.
- Partner with Production, Process and Engineering to assign work, identify bottlenecks, and mitigate risks.
- Track forecast vs. actual performance and improve planning accuracy.
- Support planning in a high-mix, high-volume manufacturing environment with both production and R&D workstreams.
- Support scale decisions, including staffing, cross-training, additional stations, and automation opportunities.
2. Project & Portfolio Management (~40%)
- Manage a portfolio of cross-functional initiatives across manufacturing scale, process improvement, engineering enablement, and operational systems.
- Develop and maintain project plans, timelines, and dependencies.
- Drive execution by tracking actions, ensuring follow-through, and escalating risks.
- Help leadership sequence priorities and align resources across operational initiatives.
- Prepare status updates, dashboards, and decision materials.
3. Additional Assignments (~20%)
Support Operations and Production leadership with initiatives that improve execution, standardization, and cross-functional coordination, including:
- Maintaining and improving SOPs and work instructions across the product lifecycle.
- Supporting process improvement initiatives to improve throughput and reduce cycle time.
- Assisting with operational reporting, dashboards, and data analysis.
- Contributing to special projects and operational initiatives as needed.
Required Qualifications
- 7+ years of experience in manufacturing operations planning and program/project management, or manufacturing operations (startup or scale‐up experience strongly preferred)
- Strong analytical skills with hands‐on experience in:
- Forecasting and capacity planning
- Resource modeling and scenario analysis
- Proven ability to manage multiple concurrent projects with competing priorities
- Excellent organizational skills and attention to detail
- Strong written and verbal communication skills
- Comfortable working in a fast‐paced, evolving environment
- Ability to manage stakeholders at various levels.
Preferred Experience
- Experience in manufacturing, hardware, photonics, semiconductors, or advanced technology environments
- Familiarity with:
- High‐volume / high mix production
- R&D and custom order workflows
- Lean, continuous improvement, or operational excellence frameworks
- Advanced proficiency in Excel / Google Sheets; experience with planning or PM tools is a plus
Program Dates: May 27th through August 7th
About Wakefern
Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite, Price Rite, The Fresh Grocer, Dearborn Markets, Fairway Markets, Gourmet Garage, and Morton Williams banners.
Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern's co-operative members benefit from the company's extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices.
About You
As more real estate opportunities present themselves due to the ever-changing market in the Mid-Atlantic area, Wakefern, in conjunction with our Members, is investing in many new stores and remodel projects. Additionally, as Wakefern grows to meet these needs, our facilities also need to be expanded and re-configured to accommodate this growth.
This internship position is a great opportunity for a student majoring in Engineering, Industrial Engineering, Construction Management, Architecture, or other related fields to gain hands-on experience working with Wakefern's Engineering Division. In this position, the intern will assist the Engineering team in project management in our Retail Engineering Design Department.
Responsibilities:
Facilities Engineering / Design and Construction
- Assist Engineering in preparation of plans using AutoCAD
- Assist Engineering Personnel in surveys of existing sites and stores to verify existing conditions
- Assist in drafting of remodels or new sites, including parking lots and stores
- Coordinate scanning of existing paper drawings into electronic files
- Visit new sites to determine best layout for building, parking and truck docks as well as truck paths through the site.
Requirements:
- Strong MS Office skills (Excel, Word and PowerPoint). Some Experience with AutoCAD or other CAD file Software required
- Valid driver's license and flexibility with regard to travel required
- Strong interpersonal, analytical and customer service skills with the ability to multitask and manage time effectively
- Excellent communication skills (written, oral and presentation)
- Ability to exhibit proper business etiquette when dealing with all levels of the organization
- Detail oriented, analytical and the ability to work in a team environment
- 5 days on site - no remote work
- Various projects as assigned
What we are looking for
- Must be at least 18 years old
- Must have completed 24 college credits with a 3.0 cumulative GPA or better
- Will be enrolled in an undergraduate or graduate school for fall
- Successful completion of a substance abuse test is required
- Successful completion of a background check is required
- Reliable transportation is required
- Strong interpersonal, analytical, and customer service skills with the ability to multitask and manage time effectively
- Excellent communication skills (written, oral, and presentation)
- Strong MS Office skills (Excel, Word, and PowerPoint required)
- Ability to exhibit proper business etiquette when dealing with all levels of the organization
- Previous work experience in a retail environment is beneficial
- Must have flexibility with regard to schedule which can include coverage for a 7-day work week, weekends, holidays, vacations and peak volume weeks (interns will work 40 hours per week)
Company Perks
- Vibrant Food Centric Culture
- Corporate Training and Development University
- Collaborative Team Environment
- Educational Workshops
- Networking Opportunities
- Volunteer Opportunities
Compensation and Benefits:
First year Facilities Engineering Interns will be paid at $17.00 per hour. Master Students and Returning Wakefern Supply Chain/Logistic Interns will be paid at $19.00 per hour. Interns are not eligible for company benefits including medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off and holidays.
Job Title: Senior Director – Electrical Engineering
Location: Union, NJ (Hybrid)
Job Timings: Full-time, Onsite
Reports To: Executive Leadership (CEO / COO)
Role Summary
The Senior Director of Electrical Engineering provides strategic, technical, and people leadership across low- and medium-voltage electrical engineering. This role owns engineering standards, design quality, technical risk management, and capability development, while scaling teams and processes to support growth, speed, and margin improvement.
Key Responsibilities
Strategy & Leadership
- Set and execute the electrical engineering strategy aligned with business growth, ISO 9001, and product roadmap
- Lead, mentor, and scale a high-performing team of senior, mid-level, and junior engineers
- Establish succession planning, skills development, and technical career paths
Technical Excellence
- Own engineering standards, design practices, and technical governance for LV and MV systems
- Ensure compliance with NEC, IEEE, UL, IEC, ANSI, and customer specifications
- Serve as the final technical authority for complex or high-risk projects
Delivery & Execution
- Partner with Sales, Project Management, Manufacturing, and Supply Chain to deliver projects on time and on margin
- Drive design-for-manufacturability, standardization, and modularization
- Review and approve critical designs, calculations, and deviations
Process & Systems
- Build scalable engineering processes aligned with ISO 9001 and Lean principles
- Leverage ERP, PLM, and digital tools to improve design cycle time and data integrity
- Establish KPIs for quality, rework, cycle time, and engineering utilization
Innovation & Growth
- Lead new product development and technology adoption (e.g., MV gear, E-Houses, Sheltered Aisles)
- Support technical sales, key customer engagements, and strategic pursuits
- Evaluate emerging technologies and vendors to maintain competitive advantage
Qualifications
Education & Experience
- Bachelor's degree in Electrical Engineering (Master's preferred)
- 15+ years of progressive electrical engineering experience in power distribution or switchgear
- 7+ years in senior technical leadership or people management roles
Technical Expertise
- Deep expertise in LV and MV power distribution systems
- Strong knowledge of codes, standards, and certification processes
- Proven experience leading complex, multi-million-dollar projects
Leadership & Business Acumen
- Strong communicator with the ability to translate technical complexity into business impact
- Experience operating in fast-paced, manufacturing-driven environments
- Track record of building teams, improving processes, and delivering results
Success Metrics (First 12–18 Months)
- Improved design cycle time and first-pass quality
- Clear engineering standards and governance in place
- Strong bench of engineering leaders and successors
- Successful delivery of strategic products and complex projects
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.
The Quality Control Lead is responsible for overseeing daily QC activities, ensuring products meet established quality standards and regulatory requirements. This role leads the QC team, coordinates testing and inspections, analyzes data, and implements corrective actions to maintain product excellence and compliance. This is a second shift role (3pm - 12am).
Key Responsibilities:
- Lead and supervise the Quality Control team in daily laboratory and inspection activities.
- Develop, implement, and maintain QC procedures and protocols in line with company and regulatory standards.
- Review and approve QC test results, ensuring accuracy and completeness.
- Coordinate in-process and final product inspections and testing.
- Investigate quality deviations, non-conformances, and customer complaints; lead root cause analysis and corrective/preventive actions (CAPA).
- Ensure compliance with Good Manufacturing Practices (GMP), ISO standards, FDA regulations, or other relevant guidelines.
- Maintain QC documentation, logs, and records to support audits and inspections.
- Train and mentor QC staff on quality procedures, equipment use, and safety protocols.
- Collaborate with Production, R&D, and QA teams to resolve quality issues and improve processes.
- Monitor laboratory equipment calibration and maintenance schedules.
- Prepare reports and present quality metrics to management.
Qualifications:
- Bachelor’s degree in Chemistry, Biology, Engineering, or related field preferred.
- 3+ years of experience in Quality Control, with at least 1 year in a leadership role.
- Strong knowledge of QC laboratory techniques, testing methods, and quality standards.
- Experience with regulatory compliance (e.g., GMP, ISO, FDA).
- Bilingual English/Spanish.
- Excellent problem-solving and analytical skills.
- Strong communication, leadership, and interpersonal abilities.
For immediate consideration please send resume outlining your related experience.