Jobs in Belle Mead, NJ

General Description:

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.

Essential Functions of the job:

• Lead the QC Biochemistry GMP laboratory through late phase activities.
• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and quality standards.
• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.
• Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.
• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.

Core Competencies, Knowledge, and Skill Requirements:

• Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
• Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
• Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Direct experience in a GMP quality control lab is a must.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Supervisory Responsibilities:

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.

Our employer is a leading provider of premium metal payment cards and secure authentication solutions. Headquartered in Somerset, New Jersey, the company serves major financial institutions, producing over 30 million metal cards annually and holding a dominant share in the premium metal card segment. It also offers advanced digital security through a proprietary platform that includes three-factor authentication and cold storage for digital assets, generating over $420 million in annual sales.

• Salary range: 85-150k USD
• Annual Bonus: Up to 15% (contingent upon a combination of company's and personal performance).

Position Summary

We are seeking an Advanced Manufacturing Engineer (Automation) who will perform the planning, design, and implementation of automation solutions across our production lines. This role involves designing and building custom machines in-house as well as managing external integrators to deliver turnkey automation systems. The ideal candidate will have a proven track record in machine design, supplier management, and project execution in high-volume manufacturing environments.

This position is critical to driving automation initiatives that improve efficiency, scalability, and quality in a multi-million-unit-per-year production setting.

Key Responsibilities

• Automation System Design & Implementation
• Design and develop custom automation equipment using SolidWorks.
• Lead full lifecycle of automation projects: concept, design, build, installation, and validation.
• Collaborate with external integrators and manage suppliers for outsourced machine builds.
• Production Line Automation
• Plan and implement automation solutions for assembly and packaging lines.
• Integrate robotics, PLCs, vision systems, and material handling equipment.
• Project Management
• Develop project timelines, budgets, and resource plans.
• Ensure projects meet performance, quality, and safety standards.
• Safety & Compliance
• Ensure all automation systems comply with OSHA, environmental, and company safety standards.
• Implement risk assessments, machine guarding, and lockout/tagout procedures.
• Maintain documentation for regulatory compliance and audits.
• Continuous Improvement
• Identify automation opportunities to reduce labor, improve throughput, and enhance quality.
• Drive cost reduction and efficiency initiatives through innovative automation solutions.

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.

Experience

• 5+ years of hands-on experience in machine design and automation engineering.
• Proven track record of designing, building, and installing machines in high-volume manufacturing environments.

Technical Expertise

• SolidWorks proficiency for machine and fixture design.
• Strong knowledge of automation technologies: robotics, PLC programming, vision systems, conveyors, and material handling.
• Experience with supplier management and working with external integrators.
• Understanding of system design, defect analysis, and process optimization.
• Familiarity with SPC, Six Sigma, and DoE methodologies for data-driven improvements.
• Ability to troubleshoot automation and mechanical issues, conduct root cause analysis, and implement corrective actions.

Preferred

• Experience designing full production lines.
• Familiarity with high-speed automation for multi-million-unit production.
• Knowledge of Lean Manufacturing principles.
• Exposure to ISO 13485 or automotive quality standards.
• Experience with robotic integration, automated quality inspection, and vision systems.

Our employer believes in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to:

• Medical, Dental & Vision Coverage
• Flexible Spending Accounts (FSA)
• Company-Paid Life and Disability Insurance
• 401(k) with Company Match
• Paid Time Off & Paid Holidays
• Annual Bonus Opportunities
• Employee Assistance Program (EAP)
• Career Advancement Opportunities

**** Benefits eligibility and details will be shared during the hiring process.

Essential Functions of the job:

• Review and validate QC data and test records.
• Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
• Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
• Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
• Undertake other duties as required.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

• Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
• Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Strong working knowledge with USP/EP and cGMP/EU GMP.
• Technical writing experience.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development
• Self-motivated, with the ability to work proactively using own initiative.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

-6 month contract

-Pay: $28/hr

Night Shift (4:30pm – 4:45am, Thu – Sat [rotating Wed])

Position Description

The Manufacturing Technician is responsible for the aseptic manufacturing of tissue-based (human and porcine) products for the regenerative market. This position involves operating simple processing equipment and manual handling of tissue to transform it into a finished product for our customers. To ensure product quality, this role much adhere to standard procedures and cGMP (Current Good Manufacturing Practices).

Main Areas of Responsibilities

• Works in a cleanroom or regulated area to process human and/or porcine tissue

• Adheres to standard operating procedures and cGMP

• Operates simple processing equipment including, but not limited to: heat sealers, biohazard laminar flow hoods, and mixers

• Monitors the quality of pre-packaged finished goods during production

• Records information on batch records, equipment and cleaning logs, and other documents.

• Uses computers, barcode scanners, and SAP to enter data and generate reports

• Maintains inventory of processing supplies

• Responsible for the sanitization of the facility

Qualifications

The below skills are attributes that may not be mandatory but are desired in the ideal candidate.

• High school diploma or equivalent required

• Minimum 1-2 years of related manufacturing experience, preferred

• Must have willingness to learn all equipment and jobs in the assigned processing area

• Ability to maintain a safe working environment and practice safe working habits

• Demonstrated attention to detail and adherence to procedures

• Demonstrated oral and written communication, critical thinking, arithmetic and proper business etiquette skills

• Must be willing and able to work with potentially biohazardous materials, including cadaveric tissue

• Ability to work in a cleanroom environment with proper gowning attire

• Ability to lift up to 30 pounds of boxes and materials off racks

• The position involves frequently sitting, walking, reaching, stooping, squatting, crouching, kneeling, crawling and stair climbing and has the ability to use fine motor skills to operate equipment and or machinery

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 Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

Key Responsibilities

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.

• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.

• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.

• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.

• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.

• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.

• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.

• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.

• Minimum 1 year of leadership, supervisory, or management experience (preferred).

• Prior experience in manufacturing, quality, or engineering is required.

• Excellent communication, leadership, and organizational skills.

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

Preferred Qualifications

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.

• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Regular, punctual attendance is required.

• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.

• Must be able to lift up to 25 lbs.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be able to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.

Job Title: Senior Analyst, QC Chemistry

Work Location: Mercer County, New Jersey

Summary:

Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and internal processes and procedures.

Responsibilities:

• Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations.
• Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures.
• Lead troubleshooting efforts for analytical methods and instrumentation related to CE.
• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc.
• Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed.
• Manage inventory of reagents and supplies for the laboratory.
• Participate in internal and external GMP audits, as needed.
• Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis.
• Serving as subject matter expert in one or more areas of required testing.
• Undertake other duties as required.

Qualifications:

• Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
• Minimum of 4+ years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
• CE experience is an absolute must have.
• Familiar with Waters Empower Chromatography Data System.
• Familiar with instrument and equipment validation.
• Working knowledge with USP/EP and cGMP/EU GMP regulations.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

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 Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.

Contract DMPK Scientist

A leading biopharmaceutical organisation is seeking an experienced Contract Scientist - Drug Metabolism & Pharmacokinetics (DMPK) to support discovery and early development programmes. This role is suited to candidates with strong hands‑on laboratory experience and a solid background in conducting DMPK studies.

Please note: demonstrated, practical DMPK experience is essential. Applicants without direct DMPK laboratory experience cannot be considered.

Key Responsibilities

• Conducting established in vitro and in vivo metabolism and bioanalysis assays
• Operating, troubleshooting, and maintaining LC‑MS/MS systems
• Supporting the development and optimisation of DMPK assays
• Analysing, interpreting, and documenting experimental data for internal project teams
• Recording study details in laboratory systems and preparing technical reports
• Ensuring adherence to safety guidelines, regulatory requirements, and internal SOPs
• Contributing to general laboratory operations, including equipment maintenance and capital equipment planning

Required Experience & Qualifications

• MSc in Biology, Chemistry, Biochemistry, Pharmaceutical Science, Pharmacology or related discipline with 2+ years of relevant experience, OR BSc in the same fields with 4+ years of relevant industry experience
• Proven experience in DMPK assays, including: Metabolic stability in microsomes and hepatocytes, CYP inhibition and induction assays, Bioanalysis in various biological matrices
• Hands‑on experience with LC‑MS instruments and automated liquid handling systems
• Strong understanding of DMPK principles and laboratory methodologies

Additional Skills

• Excellent analytical, problem‑solving, and organisational abilities
• Strong written and verbal communication skills
• Ability to manage multiple projects in a fast‑paced, matrixed environment
• Proficiency with Microsoft Office
• Ability to work both independently and collaboratively

Responsibilities

• Handle a high volume of incoming calls, live chats, and emails with accuracy and professionalism.
• Serve as the first point of contact for patients and clients; clearly explain services, policies, and procedures.
• Gather details, research solutions, and provide accurate information to resolve questions and concerns.
• Escalate clinical or medical‑related inquiries to appropriate healthcare professionals when needed.
• Schedule and manage patient appointments following established guidelines.
• Maintain accurate records of all interactions, appointments, and follow‑up steps.
• Use medical software and related technology to process scheduling and client requests.
• Partner with team members to ensure smooth workflow and a positive patient/client experience.

Qualifications

• Previous healthcare industry experience required.
• Strong computer skills; proficiency in Microsoft Office.
• Typing speed of 45+ WPM.
• Experience with medical scheduling systems or EMR tools preferred.
• Solid understanding of office procedures and office equipment.
• Ability to manage high-volume communication across multiple channels with accuracy.
• Must be able to work onsite, 5 days a week, with a patient‑focused and professional attitude.

Shift Details

• Standard hours: 7:00 AM – 7:00 PM (8‑hour shifts).
• Optional early start shifts: 5:00 AM or 6:00 AM.

****MUST HAVE EXPERIENCE IN HEALTHCARE INDUSTRY HANDLING HIGH VOLUME***********

All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit for more information.