Engineering Structures Jobs in Hamilton, NJ

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.

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.

A-Level Automotive Technician

Busy Shop. No Weekends. Real Pay. Real Respect.

The highlights (because you're busy):

• $80,000–$105,000 salary (not flat rate)
• Monday–Friday only
• No weekends
• Air-conditioned and heated shop
• Steady work with full bays
• Diagnose and fix vehicles start-to-finish
• European & Asian vehicles (European experience strongly preferred)
• Well-established shop with long-term technicians

If you're an A-Level Technician who actually enjoys diagnostics, finishing jobs correctly, and being trusted to do your work without micromanagement, keep reading.

About the Shop

This is a busy, well-established independent repair shop that's been serving the same community for decades. Customers are on a first-name basis, the bays stay full, and the shop's reputation matters.

This is not a revolving-door shop. Good technicians come here and stay here.

If you're coming from a dealership and burned out on flat rate pressure, politics, or constant comebacks, this could feel like a reset.

What You'll Be Doing

• Diagnosing and repairing vehicles independently, from intake to final test drive
• Handling complex diagnostics: drivability, electrical, HVAC, check engine lights, mechanical repairs
• Working on a consistent mix of European and Asian vehicles
• Staying productive without being micromanaged
• Using downtime wisely and taking ownership of your work
• Contributing to a team that values accountability and craftsmanship

What They're Looking For

• True A-Level Technician (or a very strong B+ operating at that level)
• 7–10+ years of hands-on experience
• Strong diagnostic skills and confidence working solo
• Reliable, professional, and consistent
• Someone looking for stability and a long-term home

Dealership technicians who are burned out and ready for a better pace are encouraged to apply.

The Work Environment

• Extremely busy, well-run independent shop
• Five bays, five lifts
• Steady workflow
• Climate-controlled workspace
• Monday–Friday schedule
• Strong customer relationships
• Long employee tenure

This is a shop where good technicians are treated like professionals.

Pay & Benefits

• Salary position (no flat rate stress)
• $80,000–$105,000 depending on experience and ability
• Medical insurance
• Paid holidays, PTO, and vacation
• Paid training and certification reimbursement
• Raises and growth based on performance, not promises

The right technician will be taken care of.

Who This Is Perfect For

This role is ideal for a technician who:

• Wants stability instead of bouncing shops
• Takes pride in diagnostics and quality repairs
• Works with urgency and purpose
• Is tired of fixing other people's mistakes

If this sounds like you — or uncomfortably close — this could be your next long-term move.

Java / Software Developer Opportunity @ BeaconFire

Location: East Windsor New Jersey

Visa Sponsorship Available | E-Verified Company

Kickstart Your Career with BeaconFire!

Are you passionate about coding and looking to grow your career in Software Development?

BeaconFire, based in Central NJ, is a leader in Software Development, Web Development, and Business Intelligence. We're on the lookout for dynamic individuals with a strong background in Software Engineering or Computer Science to join our team as Java / Software Developers!

What You'll Be Doing:

• Develop applications using Java 8/JEE (and higher), Angular 2+, React.js, SQL, Spring, HTML5, CSS, JavaScript, TypeScript, and more.
• Write scalable, secure, and maintainable code for high-impact client platforms.
• Create, deploy, and maintain automated system tests.
• Collaborate with testers to understand and resolve defects efficiently.
• Investigate new technologies and tools for continuous improvement and architecture reviews.
• Work closely with team members to achieve shared user story and sprint goals.

What We're Looking For:

• Experience in Java and JavaScript programming languages.
• A good understanding of the Software Development Life Cycle (SDLC).
• Strong object-oriented programming (OOP) skills and knowledge of Collections, Maps, Lists, Sets, and common APIs.
• Familiarity with relational databases like SQL Server or Oracle and basic SQL queries.

Preferred Qualifications:

• Master's Degree in Computer Science (CS).
• 0–1 year of hands-on experience in Java coding.
• Experience with Spring, Maven, Angular, HTML, and CSS.
• Knowledge of modern Java technologies like WebLogic, RabbitMQ, Tomcat.
• Familiarity with JSP, J2EE, and JDBC.

Why Join BeaconFire?

• E-Verified Employer
• Visa Sponsorship Provided
• Opportunities to work on cutting-edge tech
• Collaborative and growth-focused work culture

Apply Today and Build Your Future with BeaconFire!

Let's turn your passion into a profession!

About Made Scientific

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

Position Summary

The Sterility Assurance Program Lead (Associate Director) is a quality and technical leader responsible for establishing, maintaining, and continuously improving a robust sterility assurance and contamination control program across GMP cell therapy operations, from clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual will work in close partnership with Technical Operations, QC, Site Quality Operations, Plant Operations, and MSAT to ensure consistent aseptic execution, clear functional accountability, and sustained compliance with global regulatory expectations for advanced therapies.

Key Responsibilities

Sterility Assurance & Contamination Control Program

• Design, implement, and sustain a comprehensive Sterility Assurance and Contamination Control Strategy (CCS) aligned with global GMP expectations for cell therapy manufacturing.

• Ensure sterility assurance principles are embedded across facility design, equipment, processes, personnel practices, and quality systems for both clinical and commercial operations.

• Maintain alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP Annex 1 & 2, ICH guidance, and evolving global expectations for ATMPs.

Aseptic Operations & Functional Ownership

• Define and govern clear functional ownership of sterility assurance activities across Technical Operations and Quality functions.

• Provide oversight to ensure appropriate independence, compliance, and cross-functional collaboration.

Environmental Monitoring & Data Oversight

• Oversee the design and maintenance of Environmental Monitoring (EM) programs, including EMPQ, EMRA, sampling plans, alert/action limits, and response strategies.

• Review EM trends and contamination indicators to maintain a sustained state of control.

• Lead cross-functional discussions on EM excursions, contamination events, and risk mitigation.

Aseptic Process Validation & Risk Management

• Provide sterility assurance leadership for aseptic process simulation and validation.

• Oversee media fill design, execution, and failure investigations.

• Lead contamination risk assessments for process changes, new equipment, facility modifications, or tech transfers.

• Drive root cause analysis and CAPA development related to sterility assurance events.

Quality Systems Interface & Continuous Improvement

• Author, review, and approve SOPs, policies, and standards related to sterility assurance and contamination control.

• Partner with Quality Systems to embed sterility assurance into deviation management, change control, CAPA, and training systems.

• Analyze sterility assurance trends to identify systemic risks and drive continuous improvement.

• Support sterility readiness for new site start-ups, expansions, tech transfers, and product launches.

Regulatory Inspections & Audit Support

• Act as Sterility Assurance SME during regulatory inspections, client audits, and internal audits.

• Lead inspection preparation, including gap assessments, mock audits, and SME coaching.

• Lead or support response drafting for sterility-related findings, including 483s, regulatory commitments, and client observations.

Leadership, Influence & Collaboration

• Provide mentorship and leadership to sterility assurance SMEs across sites.

• Influence and align stakeholders across Quality, Technical Operations, QC, MSAT, Facilities, and Program Management.

• Advise senior leadership on sterility assurance risks, contamination trends, and program maturity.

• Champion a proactive, science-based, and inspection-ready sterility assurance culture.

Required Qualifications

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

• 10+ years of progressive experience in GMP-regulated cell therapy, gene therapy, biologics, or advanced therapy manufacturing.

• Deep expertise in aseptic processing and sterility assurance for non-terminally sterilized products.

• Strong working knowledge of global GMP regulations (FDA, EMA, ICH, Annex 1).

• Demonstrated experience supporting clinical and commercial GMP operations.

• Proven ability to lead cross-functional programs and influence without direct authority.

• Strong communication skills for diverse audiences, from operators to regulators.

• Experience leading or supporting inspections, client audits, and internal audits.

• Flexibility to work variable hours to support operations and inspections.

• Strong organizational skills and ability to manage competing priorities.

Preferred Qualifications

• Experience working in a CDMO with multiple clients and programs.

• Direct experience with EU Annex 1 implementation and contamination control strategy.

• Experience supporting late-stage to commercial transitions or high-growth environments.

• Certification or training in microbiology, aseptic processing, Lean, or Six Sigma.

Education Requirement

• B.S. in a related field required.

Physical Requirements

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

• Willingness to work in CNC/ISO7-8 cleanroom environments.

• Ability to lift up to 25 lbs.

• Must be able to stand, bend, and perform physical tasks in manufacturing environments.

• Comfortable working with cell-based products and chemicals.

LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.

A little about us...

Role: Oracle PL/SQL Developer

Location: Pennington, NJ

Job Description:

Responsibilities for PL/SQL developer

• Should have a good knowledge in Advanced PL/SQL.
• Should have exposure to Unix and shell scripting
• Exposure to debugging and troubleshooting is an added advantage
• Exposure to the financial domain is an added advantage
• Responsible for the design, development, coding, testing, debugging, and documentation of applications to satisfy the requirements of user areas
• May include hands-on new development support, maintenance, or enhancement of existing applications
• Commit to and actively work to remain knowledgeable in latest coding languages, database software, system, standards
• Model, design, and maintain data warehouse including table structures, stored procedures, views, and functions

LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.

Major, Lindsey & Africa’s Interim Legal Talent group has an immediate need for an Interim Contracts Paralegal.

Overview: Our client is seeking an Interim Contracts Paralegal to join their team and provide support across a range of contracting needs.

Company: Our client is a leading pharmaceutical and biotechnology company, they are seeking candidates with similar industry experience.

Experience: The Interim Contracts Paralegal will support the legal team by managing, drafting, reviewing, and administering a range of business‑related contracts for the procurement of goods and services, including sponsorship and membership agreements. This role requires strong attention to detail, excellent organizational skills, and experience working with commercial contracts in a fast‑paced environment.

Location: Hybrid, two days a week in their Princeton, NJ office.

Responsibilities Include:

• Draft, review, and revise sponsorship, membership, and related commercial agreements in accordance with established templates and guidelines
• Support attorneys with contract negotiations, amendments, renewals, and terminations
• Track contract lifecycles, key dates, obligations, and deliverables to ensure compliance
• Coordinate execution of agreements and maintain accurate contract records and databases
• Liaise with internal stakeholders to gather required information and resolve contract-related issues

Qualifications Include:

• Paralegal certificate or equivalent legal training preferred
• 5+ years of experience as a contracts paralegal or legal support professional, pharmaceutical experience is required.
• Strong understanding of commercial contract terms and structure
• Excellent written and verbal communication skills
• Ability to manage multiple priorities and meet deadlines under pressure
• Proficient with contract management systems and DocuSign

Information regarding benefits can be found on MLA’s Website on the Consultant Resources Page:

All interested and qualified candidates should apply directly with Major, Lindsey & Africa for review and consideration.

Major, Lindsey & Africa does not discriminate against applications on the basis of age, sex, race or any other protected characteristics pursuant to applicable state or federal laws.

Bullhorn Job ID: 242627