Engineering Structures Jobs in Windsor New Jersey

Location: Hamilton, NJ
Start Date: ASAP
Duration: Ongoing
Setting: Onsite Only
Trauma Level: Low

Schedule:

• Monday to Friday
• 8:00 AM 5:00 PM
• No call required

Case Volume & Daily Breakdown:

• Total cases: (can flex up to 100)
• 4 fluoroscopy (primarily modified barium swallow studies)
• 30 X-rays
• 20 Ultrasounds
• 10 CTs
• 10 MRIs
• No mammography or procedures

Support Structure:

• Onsite radiologist supported by remote radiologists
• Remote team covers all ED and inpatient reads
• Onsite locum focuses on outpatient reads and basic fluoroscopy

EMR: Epic

Since 1933, Stark & Stark has developed innovative legal solutions to meet our client's needs. With experienced attorneys in more than 30 practice areas, and a philosophy of putting the law to work for our clients is the basis for building and maintaining our practice.

The candidate will work on purchase and sale transactions from inception through closing, including drafting and negotiating primary and ancillary documents for M&A and similar transactions and documentation of entity formation and equity sharing arrangements. Advise clients on business structures, compliance issues, and strategic planning. Conduct due diligence on corporate, financial, and regulatory matters to identify risks and opportunities. Prepare legal opinions and memoranda on transactional and corporate matters. The candidate will work closely with other attorneys and paralegals, correspond and communicate with clients’ business and legal personnel, and coordinate with attorneys across other practice disciplines.

Qualifications

• 5-7 years of practice experience required.

• Exceptional interpersonal, drafting, negotiation, written and verbal communication skills.

• Excellent organizational skills with high level of attention to detail and accuracy.

• The right candidate is an analytical thinker with a business mind.

• Strong knowledge of contract law, corporate governance, and M&A transactions.

• Demonstrated ability to work as part of a team and to interact directly with clients.

• Admission in New Jersey is required. Admission in Pennsylvania or New York is bonus.

Benefits

Stark & Stark is committed to the health and well-being of its staff members. The firm offers a full range of benefits, including traditional major medical and hospitalization coverage, a prescription plan, a dental plan, a vision plan, life insurance, accidental death, and dismemberment coverage, a profit sharing, and a 401(k) plan, paid vacation, and paid holidays.

Mansfield Rule

As part of its continued efforts to actively recruit and advance the recruitment, development, and promotion of diverse lawyers Stark & Stark is participating in Diversity Lab’s Midsize Mansfield Rule initiative. The Mansfield Rule is named for Arabella Mansfield, the first woman admitted to practice law in the United States. It measures whether law firms affirmatively consider diverse lawyers for hiring, advancement, and significant leadership roles.

Under this initiative, we strive for a candidate pool consisting of at least 30% women, attorneys from underrepresented racial and/or ethnic groups, lawyers with disabilities, and/or LGBTQ+ attorneys. The Mansfield Rule initiative also includes a commitment by Stark & Stark to be transparent in our internal governance, particularly with our selection guidelines and job descriptions for firm management roles and committees.

Status: Full Time, Non-Exempt

Reports to: Chief Development Officer

New Jersey League of Conservation Voters (New Jersey LCV) is a bi‐partisan, non‐profit organization that protects our precious natural resources by raising awareness of key environmental challenges; increasing the efficacy of the environmental community; helping elect environmentally responsible candidates to state and local offices, advocating for strong environmental policies, and ensuring accountability to safeguard the health of our communities, the beauty of our state, and the strength of our economy.

We are committed to and incorporate into all our work, the goal of helping establish a just, inclusive, and

equitable environmental future for New Jersey. We work with, learn from, and support overburdened and low-income communities to educate the public, co‐create social change, and advocate for environmentally just policies.

Currently we are looking for a Development and Strategic Content (Associate up to Manager) to work in our collaborative environment, supporting a robust and growing grassroots fundraising program. This role will focus on supporting the Chief Development Officer and Development team with our fundraising strategies, as well as with a split focus on grant writing and digital fundraising that supports our family of organizations and political action committees. The ideal candidate will thrive in a fast-paced, energetic organization that juggles a lot of demands while working cross-organizationally with a strong, supportive team. They must be able to work independently, as well as with a dynamic Executive Director and committed Board of Directors to maximize outcomes. This position offers the opportunity for a person passionate about the environment to work with a leading conservation organization that is making a significant, positive difference in our State.

RESPONSIBILITIES

Grant Management

• Support and manage grant fundraising efforts for New Jersey LCV/New Jersey LCV Education Fund, including new grants and renewals of existing funding:
• o Write compelling one-year and multi-year grant proposals, telling meaningful "stories", including research data that supports the request, while aligning funder's criteria with New Jersey LCV/EF needs and programmatic strengths.
• o Expand the funder portfolio for grant requests by researching and identifying new institutional funders whose priorities align with New Jersey LCV/EF missions, programs and goals.
• o Demonstrate a high degree of skill in communication and positive interaction as a liaison between foundations and New Jersey LCV staff.

• Work with the Operations team to oversee and support grant management processes, ensuring all paperwork and payment tracking is managed in an effective and timely manner.
• Work proactively across teams to coordinate all programmatic and fiscal reporting requirements and deadlines as stipulated in grant documents.
• Oversee the comprehensive management of EveryAction, the organization's grant tracking system, to ensure accurate and timely monitoring and reporting of funding by source.

Strategic Development & Digital Content

• Write, edit, and coordinate fundraising-specific content across channels with creation of impactful storytelling that brings creativity and a donor-centered lens to all written communication.
• Collaborate with the Development and Communications teams to grow a creative digital outreach program by planning, executing, and evaluating performance of new digital fundraising campaigns, ensuring content aligns with organizational goals, brand, and strategy.
• Oversee the coordination and publication of the organization's Annual Report, including drafting and ensuring accurate content, managing timelines, and collaborating with teams and designers.
• Support the Chief Development Officer's major giving and high-capacity donor efforts ($10,000–$25,000+), including donor research, prospecting, and creating supporting materials.
• Provide general support across the department, as needed and assigned; including department and organization-wide fundraising strategic planning, content calendars, and campaign execution.
• Other duties as assigned.

QUALIFICATIONS

• At least 2-3 years previous nonprofit fundraising, grant writing or related experience, with a proven track record of working successfully with individuals, corporations and foundations; digital outreach experience a plus
• Commitment to our vision, mission and values, including increasing and integrating racial diversity, justice and equity into our work and organizational culture.
• Strong written, oral and digital communication skills, with a customer service focus.
• Skilled in persuasive and effective writing, with the ability to write a convincing case for support.
• Close attention to detail and ability to manage multiple projects and meet deadlines.
• Ability to work effectively with diverse teams and ranges of people, including volunteers and donors.
• A self-starter, comfortable in a team environment with colleagues in office and remote locations.
• Ability to travel for staff meetings, events, conferences and donor meetings.
• Experience with Microsoft office and donor management software preferred.

POSITION REQUIREMENTS: This is a full-time position with a hybrid work structure based in Hamilton, NJ and remotely. Travel throughout the State is necessary so a valid driver's license and continuous, real-time access to a car are required. The ability to maintain a flexible schedule common to fundraising is required.

SALARY: $40,000 - $55,000 depending upon experience and level of position for which candidate qualifies. Ranges are based on an external and organizational wage analysis, noting that new staff rarely start at the top of a range; and a very comprehensive benefits package.

To apply: Please send your resume, cover letter, and salary requirements to with "Development and Strategic Content" in the subject line. No calls please.

New Jersey LCV is an equal opportunity employer. We are committed to creating a diverse environment and is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin or ancestry, genetics, disability, age, marital status, familial status, domestic partnership status, civil union status, pregnancy, atypical hereditary cellular or blood trait status, or veteran status.

Company Overview:

Luye Pharma is fast-growing pharmaceutical company committed to advancing innovative therapies for Central Nervous System (CNS) disorders, with a primary focus on schizophrenia. Our pipeline includes promising new treatments such as Erzofri and Rykindo, which are set to launch in the U.S. market.

Position Summary:

In this role, you will collaborate closely with the US Head of Commercial Operations to design, implement, and manage data analytics and performance reporting systems. Your main responsibility will be to provide actionable insights that support decision-making and drive improvements in commercial outcomes. As the Manager of Commercial Analytics, you will serve as a key analytics partner for commercial leaders across sales, marketing, and operations in the US. You will offer valuable insights and recommendations to fuel growth, optimize field performance, and analyze market and patient trends. Additional key responsibilities include developing reporting processes and assisting with the coordination of Monthly Business Reviews, focusing on KPIs, forecasting variances, and updates to the Latest Estimate.

Report to: Head of Commercial Operation

Key Responsibilites:

• Develop and maintain performance dashboards and reports, integrating internal KPIs and external datasets to track business metrics, monitor progress toward sales goals, and evaluate operational performance.
• Conduct in-depth analysis of market trends and product performance to identify growth opportunities and risks.
• Evaluate overall business performance, including volume, market share, new patient starts, and KPIs, comparing actuals against forecasts and targets.
• Partner with Sales and Commercial Leadership to optimize territory alignments, call planning, and customer targeting, using analytical insights to improve sales coverage and operational efficiency.
• Assess performance and activity trends at sub-national levels to uncover opportunities, inefficiencies, and areas for improvement within the sales force.
• Prepare monthly business reviews, utilizing a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
• Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
• Assist in designing incentive compensation structures and performance metrics, including goal setting and attainment analysis.
• Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
• Provide support to field teams by addressing data and reporting requests, resolving inquiries, and delivering actionable insights for daily execution.
• Collaborate with cross-functional teams to develop demand forecast models.
• Conduct data analysis, reporting, and generate actionable insights to support commercial brand strategy and execution.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree
• 3-5 years of experience in relevant analytics roles within the pharmaceutical or life sciences industry.
• Strong understanding of the pharmaceutical industry and familiarity with third-party data sources (e.g., Symphony Health, IQVIA, etc.).
• Strong proficiency in Excel
• Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
• Experience with BI tools (Tableau, Power BI, Qlik etc.) preferred.

To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.

The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Luye Pharma 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, or protected veteran status and will not be discriminated against on the basis of disability

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.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

About Williams-Sonoma DC - South Brunswick, NJ

Since it was founded in 1956, Williams - Sonoma has grown from Chuck Williams' single store in Sonoma, CA into one of the largest retailers in the country, with some best known and most beloved brands in home furnishings, including Williams – Sonoma, Pottery Barn and West Elm.

Our Distribution Centers serve as vital connections between factories and our retail, online and mail-order customers around the world. The Supply Chain environment is dynamic and fast-paced, and the network is expanding rapidly. If you have a background in distribution, manufacturing, engineering, transportation, finance, human resources, or home delivery – and are looking for a job with a strong opportunity for gaining new skills and for advancement – our Supply Chain Organization could be just the place for you.

Williams-Sonoma, Inc Supply Chain Overview

By managing resources responsibly, caring for our people, and uniting around our values, we lead our industry and are proud to be recognized for our continuous action and progress in the following areas: Barron's 100 Most Sustainable Companies; Forbes Best Employers for Women and Diversity; Newsweek America's Most Responsible Companies; and USA Today Customer Service Champions. These honors reflect that we are truly a people-first organization.

• Over 4,000 Full-Time Associates across the Supply Chain
• 14.5M square feet of small parcel, personalization, furniture, and manufacturing space in the domestic US, Williams-Sonoma has developed an agile and capable distribution network consisting of the following:
• Large package / furniture distribution centers located in Southern California, Northern California, Texas, Georgia, and New Jersey totaling 9.2M square feet plus another 1.2M square feet of standalone final-mile furniture hubs.
• Small package eCommerce distribution centers located in Mississippi and Arizona totaling 3.2M square feet, consisting of over 1,000 full-time associates and 1,500 seasonal/temporary associates in Mississippi
• Sutter Street Manufacturing upholstery factories located in North Carolina and Mississippi totaling with over 1,400 full-time employees producing approximately $900 million to $1 billion in sales of upholstered furniture
• Transportation Department for Ocean, Air, Trucking, and Rail consisting of over 30 transportation professionals located in Memphis, TN
• 700 associates in our Sourcing offices in 10 countries in Asia and Europe including China, Vietnam, Singapore, India, Italy, and Turkey

The Operations Manager is located in South Brunswick, NJ.

You'll be excited about this opportunity because you will....

• Lead, coach, and develop company associates while fostering a culture of accountability, continuous improvement, and high performance
• Oversee labor scheduling, shift planning, and attendance tracking while monitoring employee productivity and operational efficiency
• Identify performance gaps and implement corrective actions through coaching, training, and structured performance management
• Conduct regular safety meetings, training sessions, and compliance audits to maintain workplace safety and operational excellence
• Drive operational discipline through performance reviews, metric tracking, and continuous improvement initiatives
• Oversee daily distribution center operations, ensuring efficient execution, cost control, and adherence to performance metrics. Monitor line-haul optimization strategies to improve delivery speed, delivery quality, and operational efficiency while reducing operating costs
• Build, maintain, and manage strong relationships with third-party delivery partners (3PLs), independent contractors, and company employees to ensure consistent adherence to company policies, operating standards, and service expectations
• Conduct routine performance reviews of third-party partners and support contract alignment to ensure delivery performance, service quality, and cost efficiency meet business objectives
• Drive a customer-centric culture by improving on-time shipping and receiving, reducing damages, and improving return and replacement rates
• Manage customer escalations and determine appropriate resolutions to maintain high service standards and overall customer satisfaction
• Develop and execute contingency plans to manage seasonal demand fluctuations, weather disruptions, and other logistical challenges that may impact delivery operations
• Oversee warehouse organization and dock operations to ensure safe and efficient staging, loading, and dispatch
• Maintain compliance with OSHA regulations and company safety policies through regular inspections, risk assessments, and incident investigations, implementing corrective actions as needed
• Ensure effective inventory control processes are in place to maintain accurate shipment tracking and minimize loss or damage

Check out some of the required qualifications we are looking for in amazing candidates....

• High School Diploma or Equivalent, and 3 - 5 years of furniture/final mile distribution or manufacturing management/leadership experience
• In lieu of a degree, 6-8 years of progressively responsible furniture/ final mile distribution leadership experience
• This is an onsite and in office role
• Strong ability to communicate effectively (written or verbal), with excellent interpersonal and customer relations skills
• Must be highly organized and process oriented
• Ability to complete multiple tasks consistently and on time
• Warehouse Management System experience
• Solid understanding of Safety and OSHA standards
• Exceptional organizational and time management skills to successfully respond to urgent situations
• Ability to adapt and change processes to keep pace with the evolving business requirements
• Strong technical skills included but not limited to Microsoft Access, Excel, Word, PowerPoint

We prefer some of these qualities as well....

• Six Sigma Black Belt or demonstrated Lean Manufacturing experience
• Knowledge and execution of Final-mile delivery models, including white-glove service and same-day or multi-day delivery routing
• Exposure to furniture manufacturing, distribution and/or big box distribution
• Final Mile Transportation carrier contract negotiations or procurement experience
• Expert understanding Safety and OSHA standards
• Bilingual in Spanish

Review these physical requirements, as they play a major part in this role....

• While performing the duties of this job, the associate is required to stand, walk, talk and hear
• Associates must be able to move, lift or carry heavy objects or materials up to 50-100 pounds

Our company benefits are second to none in the industry....

• Generous discount on all Williams-Sonoma, Inc. brand products
• 401(k) plan and other investment opportunities
• Paid vacations, Employee Assistance Programs, Time Off to Volunteer, Matching Gifts Community Service Program, and Holidays (in some locations)
• Health benefits, dental and vision insurance, including same-sex domestic partner benefits, Legal and Identity Protection Plans and Pet Insurance
• For more information on our benefits offers, please visit
• To learn more about our Supply Chain culture and regional associate events, please visit: (Login credentials may be required)

EOE

Take Your Environmental Career to the Next Level

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

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

Step into Your New Role

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

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

Responsibilities:

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

Qualifications:

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

Move Forward with Kleinfelder

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

Progress with an Employer that Values You

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

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

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

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

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

NOTICE TO THIRD PARTY AGENCIES

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

About Made Scientific

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

Position Summary

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

Key Responsibilities

Inspection Readiness & Regulatory Compliance

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

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

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

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

Regulatory Inspections, Client Audits & Customer Assessments

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

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

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

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

Quality Systems Interface & Continuous Improvement

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

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

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

Leadership, Influence & Collaboration

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

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

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

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

Required Qualifications

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

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

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

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

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

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

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

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

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

Preferred Qualifications

• Experience supporting multiple clients simultaneously within a CDMO.

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

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

• Lean, Six Sigma, or quality excellence certifications.

Educational Requirement

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

Physical Requirements

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

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

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

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

SUMMARY/OBJECTIVE:

The Senior Director, Operations is responsible for leading day-to-day operational execution across manufacturing, packaging, project management, facilities, and warehouse functions within a cGMP, CDMO, or CMO environment. This role translates company strategy into operational plans, drives performance against key metrics, and ensures safe, compliant, and efficient delivery of client programs. The Senior Director partners closely with Quality, Research & Development, Operations, Logistics, Finance and Business Development to support growth, client satisfaction, and inspection readiness.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide operational leadership and oversight for both U.S. and Ireland-based operations teams, ensuring alignment of processes, priorities, and performance expectations across sites.
• Lead daily operations across manufacturing and packaging services, ensuring schedule adherence, quality, and throughput.
• Own operational performance metrics (e.g., OTIF, right-first-time, labor utilization, cost control, and equipment performance).
• Translate strategic objectives from executive leadership into executable operational plans and priorities.
• Provide leadership and development for operations managers and cross-functional teams.
• Partner with Project Management to align production schedules with client timelines and contractual commitments.
• Ensure compliance with cGMP, FDA, DEA (as applicable), and company quality systems; support internal and external audits.
• Drive continuous improvement and operational excellence initiatives, including lean practices and waste reduction.
• Collaborate with Quality on deviation investigations, CAPAs, and risk mitigation actions.
• Support client onboarding, tech transfer, and scale-up activities to ensure successful execution.
• Work with Facilities and Engineering to optimize equipment utilization, maintenance planning, and capacity expansion.
• Collaborate with Warehouse teams to ensure material availability and inventory accuracy.
• Provide operational input during new business assessments and client proposals.
• Maintain effective communication with senior leadership on performance, risks, and resource needs.
• Comply with all company and site policies and procedures and perform other duties as assigned

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree required (Engineering, Life Sciences, or related field preferred).
• 8–12+ years of experience in cGMP pharmaceutical manufacturing and/or packaging environments, including at least 5 years supporting clinical and commercial manufacturing and packaging operations.
• 5+ years of progressive leadership experience managing operations teams.
• Experience in a CDMO/CMO or multi-client manufacturing environment required.
• Demonstrated success leading regulatory inspections and client audits.
• Strong understanding of pharmaceutical packaging, production planning, and operational controls.

COMPETENCIES/SKILLS:

• Strong operational leadership and execution mindset.
• Excellent analytical, problem-solving, and decision-making skills.
• Ability to interpret data and drive performance improvements.
• Effective communication and stakeholder management skills.
• Financial acumen with experience managing budgets and operational costs.
• Ability to lead cross-functional teams in a fast-paced CDMO environment.
• High integrity, professionalism, and accountability

SUPERVISORY RESPONSIBILITIES:

Yes. Typically includes Production/Packaging Managers, Warehouse leadership, Facilities leadership, Project Management and other operations personnel as assigned.

WORK ENVIRONMENT:

Hybrid office and manufacturing environment; routine presence on the production floor required.

SCHEDULE:

On-site 5 days per week in Cranbury, NJ office

SALARY:

$190,000 - $240,000

PHYSICAL DEMANDS:

Combination of office-based work and time in warehouse/manufacturing areas. Ability to stand, walk, and move through production areas as needed.

TRAVEL:

Up to 20–30% travel may be required based on client and business needs.