Jobs in Hightstown

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.

We are looking for remote participants to review financial advice related to budgeting, saving money, and improving spending habits.

In this role you will explore different strategies people use to manage their finances and identify which ideas are the most helpful in real life.

Tasks include reviewing simple financial tips, evaluating money-saving strategies, and providing feedback on budgeting approaches.

The role is remote and open to anyone with an interest in personal finance or household budgeting.

We are hiring remote contributors to review consumer finance content focused on budgeting and money-saving strategies.

Your role will involve reading short financial guidance pieces and providing feedback on their usefulness for people managing tight budgets. You may also identify which tips are the most practical for everyday situations.

This position is ideal for people interested in personal finance, budgeting, or improving financial literacy.

The work is flexible and completed online.

We are seeking individuals to review and provide feedback on everyday money-management tips. This role focuses on common financial challenges such as managing expenses, reducing spending, and making smarter financial choices.

You will review examples of budgeting methods and evaluate practical ideas people use to stretch their income. The goal is to understand which approaches work best for real households.

The work is flexible and fully online. Applicants should have an interest in budgeting, saving money, or improving financial habits.

No formal finance background is required.

We are looking for people who are interested in personal finance and budgeting. In this role you will review practical money-saving strategies and provide feedback on budgeting ideas for everyday households.

You will look at different financial habits, common spending patterns, and simple ways people manage money when budgets are tight. The work is simple and can be done online.

Responsibilities include reviewing budgeting advice, identifying useful money-saving ideas, and sharing your opinion on which strategies are most helpful.

No professional experience is required, but an interest in personal finance, saving money, or budgeting is helpful.

This is a remote opportunity and can be completed from home.

Financial Highlights – Enjoy an Immediate Pay Raise and Professional Growth!

$10k Fast Start Bonus Per Month for 12 months, $120k First Year, requires one new commercial account with at least 250 employees, every two weeks.

$2,500 First Week Training Pay for the first five training days.

$500 per virtual appointment bonus with food with no bonus limit.

Up to $1500 per week for meeting minimum call and one qualified onsite appointment.

200% of the profit margin for the first 90 days of orders shipped.

40% to 59% of the profit margin after 90 days

Up to $10k new client account credits

Up to $5k new account donation credits

Up to $400 of gift cards for business building activities

GHA Technologies, Inc. has become the #1 Employee-Owned Value-Added Reseller in America. Past rewards have included #1 Microsoft Western Region VAR, #1 fastest growing company in Arizona, #69 on the CRN Solution Provider 500, #15 2018 CRN Fast Growth 150 List.

We sell the latest AI technologies from Nvidia, Dell, HP, Microsoft, Google, Cisco, Lenovo, Apple, VMWare, Adobe, APC, IBM, Nutanix, EMC, Pure Storage, Samsung, Intel, Eaton, and all the hottest AI and Green Data Center, Virtualization, Energy Conservation, Cloud, Storage, Security, Wireless, SD Wan, Video, Identification, and Power Technologies! We also specialize in mission critical product procurement and integration services for some of the largest Corporate, Government, and Education clients in America! Our client base is a who's who of corporate America!

GHA employee owners will receive stock shares every year on top of our industry’s leading commissions, bonuses, and promotional offerings!

Mission critical, online, vast E Commerce distribution network coast-to-coast warehouse locations support just-in-time delivery.

Super convenient, orders placed by 9:00 p.m. EST (8:00 p.m. CST) can be received the next morning for in-stock items.

Secure, 24-hour access to your own personal portal customized with special pricing on more than 2 million top selling products from 3,500 manufacturers in the USA and across the globe.

We are currently HIRING experienced Sales Professionals nationwide with a minimum of three years direct technology sales experience.

We offer a highly lucrative earnings and benefits package with top salespeople earning between $96,000 to $2,000,000 annually. W-2 Employment, Medical, Dental, and HSA Benefits, 401K Retirement Plan, and GHA company stock ownership (ESOP) plan.

Please email your resume to and schedule a strictly confidential interview.

Visit us at:

About the Role- Come Join the American Fidelity Family!

American Fidelity Assurance is now looking for an Account Manager (Outside Sales Representative) in New Jersey.

Our salaried account managers are responsible for selling benefits, retirement, and other insurance products and services within the Private Sector in a defined sales territory with an existing customer base and bringing in new accounts. You will build strong, long-term relationships with businesses and develop specific, needs-based recommendations for their employees, highlighting the benefits of American Fidelity's insurance portfolio.

We Offer

• Base salary + uncapped commission + additional bonus potential
• Company car, company credit card and paid travel expenses.
• International sales award trips
• Average first-year income is between $87,000 to $119,000.
• 100% match when contributing 6% to your 401(k), with more matching opportunities after five years
• You will have a defined territory
• Multiple sales career path options
• Consistent, standardized training designed for new Account Managers
• Comprehensive benefits package includes medical, dental, vision and supplemental insurance plans.

Progression for the Account Manager Role:

• Sr. Account Manager
• Executive Account Manager
• Account Executive
• Sr. Account Executive
• Executive Account Partner

Primary Responsibilities

Focus on growing and maintaining existing Business-to-Business accounts by one-on-one sales of worksite insurance products and services to the community. Consult with current customers to provide value and meet financial needs. Build strong relationships with customers and association executives. Develop customized needs-based employee benefits packages through annual benefit enrollments, group presentations, and new account development opportunities.

Defined Territory – Each Account Representative is assigned a territory to manage and develop new accounts. Overnight Travel is Required. Must reside in the specific territory.

Extended Training Program—Account Representatives participate in a structured, comprehensive training program that includes on-the-job training within their territory, product & sales schools, and online training.

Company Overview

Founded in 1960, American Fidelity Assurance Company is a private, family-owned company specializing in the education, public sector, automotive and healthcare industries with products like group and individual life, health and annuity services as well as other financial security products and services.

For more information on our company, visit .

A Great Place to Work for All

American Fidelity is a certified Great Place to Work for All by the consulting company Great Place to Work. Being a salesperson is a challenging career, but it’s a lot easier when you enjoy coming to work and believe in what you’re selling. That’s why at American Fidelity we offer products designed to help people.

We train our Sales Colleagues to serve as consultants who help people decide which products are best for them – and which aren’t. Being honest and transparent is a huge part of our culture – and that extends to our relationships with customers and policyholders.

Being a Great Place to Work for All is another driver of our culture, and we are committed to creating an inclusive environment where everyone's voice is valued and respected.

If you'd like information about American Fidelity's privacy practices, please visit /privacy.

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.

Position Summary

Provide strategic leadership for Quality Assurance programs across U.S. operations, ensuring compliance with applicable global regulations and industry standards. This role is responsible for driving quality excellence, regulatory readiness, and continuous improvement across research, development, clinical, and manufacturing activities.

Responsibilities

• Provide strategic and scientific leadership for the organization’s Risk-Based Quality Management System (QMS).
• Lead and oversee Quality Assurance functions supporting R&D, Clinical, CMC, and Manufacturing operations.
• Direct GxP compliance activities and lead regulatory inspections, including interactions with global health authorities.
• Drive execution of the company’s global QA strategy in alignment with established quality standards and policies.
• Establish, govern, and monitor global quality processes and procedural frameworks.
• Identify and implement quality improvement initiatives based on compliance trends, metrics, and industry benchmarks.
• Serve as a subject matter expert in GxP principles and quality systems.
• Maintain current knowledge of regulatory expectations, industry trends, and best practices.
• Oversee development and delivery of internal and external GxP training programs.
• Collaborate with internal and external stakeholders, regulatory agencies, and strategic partners to support organizational objectives.

Qualifications

• Advanced degree preferred; Bachelor’s degree required.
• 15+ years of experience in the pharmaceutical or biotechnology industry.
• Proven leadership experience managing cross-functional Quality Assurance teams.
• Deep knowledge of R&D QA, GLP, CMC, and Manufacturing QA environments.
• Strong understanding of global regulatory requirements, including GMP and regulatory inspections.
• Demonstrated expertise in Quality Management Systems and compliance frameworks.
• Experience supporting complex, multi-site, or international organizations preferred.
• Strong strategic thinking, communication, and stakeholder management skills.
• Ability to lead large-scale programs, initiatives, and organizational change.

Position Summary:

We are seeking a detail-oriented and motivated Junior Accountant to join our Finance team,

with a specialized focus on pharmaceutical accounting. This role is ideal for someone with

foundational accounting experience and a strong understanding of the pharmaceutical

industry’s understanding of G2N and revenue analysis, rebate structures, including

commercial, Medicaid, and Medicare Part D programs.

Key Responsibilities:

• Assist in the preparation, review, and processing of rebate claims and accruals.
• Support monthly, quarterly, and annual financial close activities related to rebates.
• Reconcile rebate-related accounts and ensure accuracy of general ledger entires.
• Collaborate with cross-functional teams including Sales, Contracts, and Market Access to validate rebate data.
• Maintain documentation and audit trails for all rebate transactions
• Assist in preparing reorts and analysis for management and external auditors
• Ensure compliance with GAAP and internal financial policies
• Participate in system upgrades or implementations related to rebate tracking and accounting
• Perform other duties as assigned

Qualifications

• Degree in Accounting, Finance, or related field
• 1-3 years of accounting experience, preferably in the pharmaceutical or halthcare industry
• Familiarity with rebate programs (e.g., Commercial, Medicaid, Medicare Part D)
• Strong Excel Skills; experience with ERP systems (e.g., QuickBooks, SAP) is a plus
• Excellent attention to detail and organizational skills
• Ability to work independently and as part of a team in a fast-paced environment

Preferred Skills

• Experience with contract management systems and rebate processing platforms
• Understanding of government pricing regulations and pharmaceutical compliance
• Strong analytical and problem-solving abilities

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