Jobs in Pennington

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.

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.

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.

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