Engineering Structures Jobs in Dayton, NJ

Overview

Boden Talent is proud to be partnering with our client to appoint a Senior Account Director to lead a high-profile, single-customer facilities management account across Class A office locations in the United States.

This is a strategic leadership role with full operational and commercial accountability for a $7m+ maintenance revenue portfolio. The successful candidate will act as the single point of contact for the client, ensuring contractual commitments are consistently met and exceeded while driving service excellence, innovation, and sustainable growth.

The Role

The Senior Account Director will provide strategic leadership, operational oversight, and commercial management across the full suite of hard and soft FM services. This individual will foster strong stakeholder relationships, drive performance, and ensure the delivery of exceptional service standards across all locations.

Key Responsibilities

Operations & Client Leadership

• Lead, coach, and develop the account team to ensure contractual commitments are delivered and exceeded
• Act as the single point of contact for all account operations and contractual compliance
• Oversee preventative and reactive maintenance, vendor management, helpdesk operations, soft services (where applicable), and additional project works
• Identify and execute strategic growth opportunities, driving organic growth through extra works and projects
• Ensure account retention through exceptional service delivery and stakeholder engagement
• Establish and maintain effective governance, audit, and compliance frameworks
• Lead regular client reviews (monthly, quarterly, annual), ensuring transparency and alignment
• Deliver accurate and timely reporting, financial summaries, and strategic recommendations
• Develop and implement emergency preparedness, disaster recovery, and business continuity plans
• Drive innovation and thought leadership to deliver value-added solutions
• Support business development initiatives including solution design and client presentations

People & Leadership

• Provide strong leadership, mentoring, and performance management across the account
• Foster a culture of engagement, inclusion, and continuous improvement
• Ensure appropriate staffing structures that balance service excellence with cost efficiency
• Lead all key hiring decisions and succession planning initiatives
• Ensure training and development plans are in place to support long-term capability building
• Promote a positive and collaborative team culture aligned with organizational values

Finance & Commercial

• Full P&L responsibility for the account
• Develop and manage financial plans covering revenue, profit delivery, WIP, debt, and cost control
• Ensure accurate commercial governance and financial reporting
• Review and approve purchase orders to ensure contractual and financial compliance
• Manage supply chain performance including supplier reviews, negotiations, and re-bidding
• Drive sustainable organic growth through additional scope and project opportunities

QHSE

• Ensure a safe and compliant working environment across all sites
• Implement and maintain health and safety policies across all service lines
• Conduct periodic facility inspections to ensure quality assurance
• Ensure compliance with all local, state, and federal regulations
• Develop and maintain environmental health and safety procedures

Leadership Scope

• Direct supervision of operational staff including Engineers, Technicians, and Contract Support
• Accountable for recruitment, performance reviews, workforce planning, and development
• Lead by example, modelling high-performance behaviors and professional standards

About You

To be successful in this role, you will bring strong strategic, operational, and commercial leadership experience within a facilities management or multi-site service environment.

Experience & Qualifications

• Bachelor’s degree (preferred)
• 8+ years’ relevant experience in facilities management or account leadership
• Proven experience managing a P&L
• Experience operating within a complex, multi-site environment
• Must be authorized to work in the United States without visa sponsorship

Skills & Competencies

• Strong commercial acumen and financial management capability
• Advanced analytical and strategic problem-solving skills
• Exceptional stakeholder engagement and client relationship management
• Ability to communicate complex information clearly and persuasively
• Strong leadership presence with the ability to influence at senior levels
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

Reporting Line

Reports to: Business Unit Director

Key internal partnerships include Finance & Operations Support Manager and Business Operations Manager.

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

Starting at $20.50 per hour!

Job Summary: The Emergency Medical Technician will provide medical care to our employees and guests. Maintain a safe environment and project positive Public Relations. Abide by and enforce all rules, regulations, and policies established by the Management of the Company with respect to the Laws of Local, State and Federal Government.

Essential Duties and Responsibilities:

• Provide medical care to our Employees and Guests.
• Provide Emergency transportation for Employees and Guests as needed.
• Maintain all equipment and facilities of the Medical Division.
• Maintain and properly secure all medical records. Including in-putting all incidents in the computer.
• Conduct Safety Inspections throughout the Park(s) as requested by the Safety Manager.

The Ideal Candidate Must Possess:

• Must be 18 years of age and have a VALID Drivers License
• Must be an Active NJ, NY, PA State or Nationally Certified EMT, with current certifications including CPR.
• Must be able to read and write legibly, and understand all medical terms and have understanding of computer in-put programs.
• Ability to maintain composure and treat guest(s) or employee(s) on a one-to-one treatment environment.
• Ability to perform EMT care inclusive of Lifting Adult individuals onto and off of stretchers with the assistance of only one other person. (Approx. 100 lbs.)

Rate: $18.00 per hour

Job Summary: This role is responsible for maintaining the park's quality landscapes and assist in maintaining safe and clean park. Landscapers are required to interact with guests, fellow associates, leads and supervisors on a daily basis. Additionally, Landscapers are required to continuously work outdoors and closely with others. Occasionally will work alone. Will always be exposed to direct sunlight, dust, dirt, and water. Must be able to function in all weather conditions for long periods.

Skills and Qualifications:

• Must react well in stressful and emergency situations.

• Able to work efficiently in a fast-paced environment.

• Safety conscious.

• Outgoing and friendly demeanor.

• Willing to actively engage guest.

• At least 18+ years of age.

• Must be able to stand/walk for up to 6 hours at a time and as many as 14 hours a day.

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.

Senior Mechanical Engineer / Project Manager – Healthcare (MEP)

Key Responsibilities:

• Lead mechanical/HVAC healthcare projects from design through execution
• Manage project teams, budgets, schedules, and QA/QC reviews
• Perform HVAC load calculations, energy modeling, and engineering analysis
• Develop construction documents (HVAC, plumbing, fire protection, electrical/IT)
• Ensure compliance with NFPA, FGI, Joint Commission, and AHJ codes
• Provide client coordination, proposal support, and field construction assistance

Required Qualifications:

• 10+ years in healthcare or laboratory MEP engineering
• Strong HVAC design & multi-discipline coordination experience
• Proficiency in AutoCAD, Revit, and energy modeling tools (eQUEST, Trane Trace, Carrier HAP)
• Excellent project management, leadership, and communication skills
• Professional Engineer (PE) License – Required

Preferred:

• Master's degree in Engineering
• LEED knowledge/USGBC experience
• Experience in pharma, biotech, or medical device facilities

Industry: Healthcare Engineering / MEP Consulting

Core Skills: HVAC Design | Mechanical Engineering | Project Management | QA/QC | Energy Modeling | Healthcare Facilities Design

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

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.