Career at
J-STAR Research

Quality Assurance Specialist – Sustainability wanted by J-Star Research Inc in Cranbury, NJ, with Master’s degree in Sustainability Management and at least 2 years of experience in quality assurance and in drug development industry. Must have knowledge of environmental management, sustainability management, environmental risk management, value chain management, hazardous waste  management, environmental audit, environmental data analysis, resource management, life cycle assessment, benefit-cost analysis, GMP compliance, validation documentation, lifecycle documentation, IQ/OQ/PQ, FDA regulations, GMP in Manufacturing Processing, GMP for Finished Pharmaceuticals, Root Cause Analysis, CAPA, statistical analysis, process validation and improvement. Job duties to be performed:

• Perform facility condition assessments on energy consumption, chemical waste treatment, etc. to ensure compliance within corporate environmental, health & safety policies and government regulations.
• Conduct regular inspections to ensure compliance with sustainable regulations and certifications.
• Establish and improve quality management systems to support GMP manufacturing and testing with a focus on sustainability and quality control compliance.
• Provide strategic support in relation to sustainability and quality control for the GMP facility expansion and validation of all GMP systems.
• Provide sustainability and quality oversight for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
• Perform cost-benefit analysis for sustainability projects; review and propose changes to the plant’s policies and procedures for material and waste management.
• Establish and execute a Data Integrity Program; provide support for the management and maintenance of the SOP and document control system in relation to the quality control and sustainability activities of the facilities.
• Author, review, update, and approve sustainability and quality documents, validation protocols and reports, specifications, and procedures as needed.    

Salary:             $90,000.00

Benefits:          401(k) & 401(k) matching, health insurance, dental insurance, vision insurance, paid time off.

Please send resume to HR@JSTAR-Research.com using subject line: QL-Quality/J-Star Research Inc.

Job Description:

We are seeking an experienced NMR Spectroscopist to join our team in the CDMO industry. The ideal candidate will be responsible for the maintenance and buildout of our NMR facility, troubleshooting NMR instrumentation, and performing structural elucidation of small molecule drug substances. This role also involves identifying and elucidating impurities and degradants, and effectively communicating NMR data for structural analysis. Strong teamwork and excellent communication skills are essential.

J-STAR Research, Inc. is a subsidiary of Porton that specializes in providing contract chemistry services to the biopharmaceutical and biotechnology industry. Our primary focus is resolving intricate chemistry problems relating to Active Pharmaceutical Ingredients and Intermediates in the preclinical and clinical development phases. We are adept in synthetic chemistry and process research services, which include Process Chemistry, Quality Control, Good Manufacturing Practice, Quality Assurance, Crystallization Research and Development, Solid Form and Polymorph Screening, Catalysis Screening and Enabling Technology, High Potent Compound Handling (HPAPI), Impurity Isolation and Structural Elucidation, and Preformulation and Formulation Research and Development.

At J-Star, there are 5 NMR systems including one 500 MHz H/C/N Cryoprobe as well as two 400 MHz Bruker systems with multiple-nuclear and variable temperature capabilities. We are hiring an NMR Spectroscopist to support project team decisions and improve the speedy delivery of API for our clients.

Responsibilities:

• Oversee the general maintenance and development of the NMR facility.
• Independently troubleshoot and resolve issues with NMR instrumentation.
• Perform structural elucidation of small molecule drug substances, intermediates, and starting materials.
• Identify and elucidate the structures of related impurities and degradants from API synthesis, fate and purge, and stress degradation studies.
• Provide clear oral and written explanations of NMR data for structural elucidation.
• Collaborate effectively with a team of chemists.

Requirements:

• Ph.D. with 5+ years or MS with 10+ years of post-graduate industrial or academic experience in small molecule NMR data collection and interpretation.
• Degree in Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Physics, or a related field.
• Experience troubleshooting NMR hardware and software (Bruker and Varian), including magnets, consoles, conventional and cryoprobes, autosamplers, and workstations (Windows and Linux).
• Demonstrated ability to creatively apply NMR techniques to pharmaceutical problems.
• Strong understanding and application of NMR theory for solving chemical structures and interactions of small molecules.
• Experience using 1D (1H, 13C, 19F, 15N, etc.) and 2D (COSY, ROESY, HSQC, HMBC, TOCSY, etc.) multinuclear solution-state NMR techniques on high-field NMR instruments (300-500 MHz) equipped with conventional and cryoprobe technology.

Experience:

• NMR Experience: 4 years (Required)
• Pharmaceutical CDMO Industry Experience: 5 years (Preferred)

Relocation:

• Must be able to relocate to Cranbury and South Plainfield, NJ before starting work (Required)

Work Location:

• In-person

Position Summary:

We are seeking a highly motivated and detail-oriented Drug Product Manufacturing Specialist to join our GMP drug product production team. This role will support the Head of the GMP Pilot Plant in the manufacturing of drug products for early-phase clinical studies. The successful candidate will oversee both GMP compliance and the operation of processing equipment, ensuring high-quality drug product manufacturing while maintaining adherence to regulatory standards.

Key Responsibilities:
Manufacturing Operations:

• Execute and oversee drug product manufacturing processes, including equipment setup, operation, cleaning, and maintenance.
• Support the production of solid and liquid drug products in compliance with GMP guidelines.
• Troubleshoot and optimize manufacturing processes and equipment to ensure efficiency and quality.

GMP Compliance and Documentation:

• Prepare and maintain GMP documentation, including batch records, SOPs, and equipment logs.
• Perform quality checks on manufacturing activities to ensure alignment with regulatory requirements.
• Participate in GMP audits and implement corrective actions to address findings.
• Ensure proper traceability and documentation for all raw materials, intermediates, and final products.

Collaboration and Team Support:

• Work closely with cross-functional teams, including formulation scientists, quality assurance, and analytical development.
• Train and supervise technicians on GMP processes, equipment operation, and documentation practices.
• Assist in the transfer of processes from development to GMP manufacturing, providing technical support and troubleshooting expertise.

Equipment Management:

• Operate and maintain processing equipment, such as granulators, fluid bed dryers, spray dryers, capsule fillers, and tablet presses.
• Perform periodic calibration and qualification of manufacturing equipment.
• Collaborate with engineering teams to ensure equipment readiness and address technical challenges.

Continuous Improvement:

• Identify opportunities to enhance manufacturing processes, reduce waste, and improve efficiency.
• Stay updated on industry trends and regulatory changes to ensure best practices in GMP manufacturing.

Qualifications:

• Education: Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, or a related field.
• Experience: 5+ years of experience in GMP drug product manufacturing, preferably in a pilot plant or early-phase clinical setting.
• Familiarity with manufacturing processes such as blending, granulation, compression, coating.
• Strong knowledge of GMP guidelines and regulatory requirements for drug product manufacturing.
• Proficiency in preparing and reviewing GMP documentation.

Key Skills:

• Strong organizational skills with attention to detail.
• Excellent problem-solving and troubleshooting abilities.
• Ability to train and mentor junior staff.
• Effective communication skills for cross-functional collaboration.
• Technical aptitude for operating and maintaining complex manufacturing equipment.

Work Environment:

• Hands-on work in a pilot plant setting, requiring adherence to safety and cleanliness protocols.
• Occasional lifting of equipment components or raw materials may be required.

Job Summary:

We are seeking a highly motivated and skilled Drug Product Production Manager to join our Drug Product Department at Porton J-STAR. In this role, this position is responsible for supervising the drug product GMP manufacturing activities in the Drug Product Development group and ensuring smooth technology transfer of R&D processes into the GMP manufacturing suites. The responsibilities include, but are not necessarily limited to, the items listed below.

Responsibilities:

• Establish GMP drug product manufacturing system, including but not limited to qualify the facility, procure and perform IQ/OQ of equipment, establish appropriate procedures for maintaining high standards.
• Support drug product development R&D system, including but not limited to procurement of equipment and establishing appropriate procedures.
• Manage the manufacturing activities to ensure that all products conform to established customer and company quality standards.
• Ensure all GMP planning, manufacturing, cleaning, and storage operations run efficiently.
• Author/review/approve protocols, updates, development reports, BMRs, SOPs, CMC regulatory documents & other quality documentation according to regulatory guidelines.
• Work with R&D scientists and drug product GMP manufacturing team to ensure smooth technology transfer of R&D processes into the GMP manufacturing suites.
• Collaborate closely with QC, QA, Maintenance & other groups to ensure timely production & release of clinical trial materials.
• Lead root cause investigations, risk management, deviations, CAPAs as required.
• Identify, recommend, develop, and implement necessary changes, within the appropriate regulatory confines to improve productivity and for continuous process improvements.
• Adhere to EHS policies and maintain work areas in a safe, clean, and orderly fashion.
• Ensure the training program for all levels of manufacturing are current and complete and production personnel are qualified to perform work assigned.
• Ensure a rigorous preventative maintenance schedule is implemented and sustained for all GMP equipment and instrumentation.

Qualifications:

• BS, MS or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with a focus on drug product manufacturing, preferably within a CDMO or pharmaceutical environment.
• Minimum of 3-7years of hands-on experience in drug product formulation and process development, ideally within a CDMO or pharmaceutical environment.
• Proven experience with GMP manufacturing processes, technology transfer from R&D to GMP manufacturing, and understanding of cGMP regulations.
• Strong leadership skills, with the ability to manage teams and coordinate cross-functional departments to achieve operational goals.
• Ability to lead root cause investigations, manage CAPAs, and implement corrective actions to address manufacturing issues.
• In-depth knowledge of regulatory guidelines, quality systems, and industry best practices.
• Strong communication skills, both written and verbal, with the ability to convey complex scientific concepts clearly.
• Leadership skills with experience mentoring or coaching junior scientists.
• Excellent project management skills, including the ability to prioritize tasks, manage timelines, and meet deadlines.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.

Job Summary:

We are seeking a highly motivated and skilled Research Scientist to join our Drug Product R&D Department at Porton J-STAR. In this role, this position is responsible for leading formulation development and optimization for oral (tablets, capsules, solutions, suspensions) and injectable dosage forms. This includes operating various processing equipment (e.g., granulators, tablet presses, spray dryers) and applying analytical techniques (e.g., HPLC, DSC, TGA) to generate reliable data. The role also involves assisting in scaling up products from lab to GMP scale for clinical trial material, presenting findings to management and stakeholders, and documenting all data in compliance with GDP. The scientist will manage multiple projects, prioritize tasks, and ensure adherence to protocols, SOPs, and EHS guidelines for continuous improvement.

Responsibilities:

• Lead the planning, design, and implementation of assigned research projects, integrating innovative methodologies and technologies to meet project goals.
• Collaborate with multidisciplinary teams to incorporate scientific insights into broader project objectives, ensuring alignment with development timelines and client requirements.
• Foster a collaborative and inclusive work environment, promoting knowledge-sharing and teamwork. Mentor and guide junior scientists to enhance team performance and skill development.
• Conduct formulation development and optimization studies for oral (tablets, capsules, solutions, suspensions) and injectable dosage forms. Focus on developing robust formulations for both small and large molecules.
• Operate various processing equipment (e.g., wet/dry granulation, fluid bed dryers, tablet presses, capsule fillers, spray dryers, hot melt extruders) and apply advanced analytical techniques (e.g., HPLC, DSC, TGA, SEM, XRD, dissolution) to generate high-quality, reproducible data.
• Lead the analysis, interpretation, and presentation of complex experimental data using statistical software and other data analysis tools. Ensure data integrity and quality.
• Lead the scaling-up process from laboratory scale to GMP scale for the production of clinical trial material, ensuring smooth transition and process validation.
• Prepare and review research protocols, updates, master batch records, development reports, CMC regulatory documents, and SOPs in compliance with regulatory and quality standards (e.g., FDA, EMA, ICH).
• Ensure all research activities comply with applicable regulatory requirements, quality standards, and industry best practices. Maintain compliance with GDP during data documentation.
• Perform laboratory work adhering to safety protocols, PPE utilization, and regulatory guidelines, ensuring safe work practices and environmental compliance.
• Effectively communicate complex scientific findings, technical concepts, and project status to both internal teams and external stakeholders (e.g., clients, regulatory bodies). Present research findings clearly and concisely.
• Manage multiple projects simultaneously, prioritize tasks, and meet deadlines. Provide regular updates on project status, risks, and milestones, contributing to project planning and scheduling.
• Stay up to date with the latest scientific advancements and industry trends. Lead the identification and integration of emerging technologies to improve research capabilities and efficiency.
• Actively participate in Environmental Health & Safety (EHS) discussions and initiatives, fostering a culture of safety and continuous improvement.

Qualifications:

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with a focus on drug formulation or drug product development. Alternatively, a Master’s degree with significant relevant experience may be considered.
• Minimum of 3-5 years of hands-on experience in drug product formulation and process development, ideally within a CDMO or pharmaceutical environment.
• Expertise in the development of oral and injectable dosage forms, as well as familiarity with GMP and regulatory requirements.
• Strong experience in operating and troubleshooting various formulation and processing equipment (e.g., granulators, tablet presses, coaters, extruders, etc.).
• Knowledge of advanced analytical techniques (e.g., HPLC, DSC, TGA, SEM, XRD) and data analysis using statistical tools (e.g., Minitab, JMP).
• Strong communication skills, both written and verbal, with the ability to convey complex scientific concepts clearly.
• Proven ability to work independently and as part of a cross-functional team.
• Leadership skills with experience mentoring or coaching junior scientists.
• Excellent project management skills, including the ability to prioritize tasks, manage timelines, and meet deadlines.
• Track record of scientific success as measured by publications and presentations.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.

Job Summary:

We are seeking a highly motivated and skilled Research Scientist to join our Crystallization R&D Department at Porton J-STAR. In this role, this position is responsible for leading group or contributing individually to conduct Solid Form Studies and pre-formulation will search for the right solid form and develop formulations to support preclinical and Phase I studies including PK, PD, efficacy, tox studies. This role is also responsible for Crystallization Process Development will develop crystallization processes to define and control final solid form of drug substances with desired solid-state attributes needed for optimum performance as well as drug intermediates for robust purification. The responsibilities of the position include, but are not necessarily limited to, the items listed below.

Responsibilities:

• Develop innovative technologies focused on improving the efficiency of laboratory crystallization and to provide greater depth of process understanding with the application of Process Analytical Technology (PAT) and process modeling.
• Carry out rational design and control of drug substance physical properties through particle engineering technologies and drug substance-drug product coprocessing.
• Perform activities in phase-appropriate solid form selection and physicochemical characterization, such as powder X-ray diffraction, DSC, TGA, SEM, particle size, polarized light microscopy, moisture sorption analysis, solubility, dissolution and stability assessments.
• Map polymorph, salt and cocrystal spaces of drug substances for selection of final solid form for development
• Understand solid form phase mapping of drug candidates to assist in crystallization process development
• Designs experiments, strategies and workflows to improve bioavailability of poorly soluble drug molecules through enabling technologies.
• Lead or contribute to research and development of crystallization processes, solid form characterization, and pre-formulation studies for drug candidates.
• Conduct particle engineering studies and develop strategies for improving crystal form stability, solubility, and bioavailability.
• Investigate and apply new methodologies in crystallography and co-processing to optimize solid-state properties.
• Coordinate and lead scientific and technical discussions with internal teams (e.g., project scientists, formulation scientists, analytical teams) and clients to plan, execute, and resolve project-related challenges.
• Ensure effective communication across teams, maintaining clear and timely updates on project status and progress.
• Coordinate weekly client updates and ensure that all team members provide timely progress reports.
• Prepare and submit final technical reports and documentation to clients in accordance with project timelines.
• Provide clear, candid, and professional communication with clients, peers, and management on project status, challenges, and outcomes.
• Lead idea generation for proposals, quotes, and project plans, ensuring that proposed solutions align with client needs and project objectives.
• Maintain a safe and clean laboratory environment, adhering to laboratory safety protocols and best practices.
• Contribute to the development, calibration, and maintenance of laboratory instruments and equipment to support crystallization and solid-state research.
• Maintain accurate and detailed scientific records, including lab notebooks, experimental data, and process development documentation.
• Ensure all documentation is compliant with Good Laboratory Practice (GLP) and regulatory requirements.
• Perform other relevant duties as assigned by management, including supporting various R&D initiatives and participating in team-wide process improvements.

Qualifications:

• MS or BS. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a focus on crystallization, solid-state chemistry, or materials science.
• 1-5 years of experience in solid form studies and preformulation development, crystallization process development or chemical process development. (solution, suspension, tablet, capsule, etc).
• Good understanding of solid-state chemistry of small molecule drug substances.
• Working knowledge of analytical techniques such as PXRD, TGA, DSC, PLM, DVS, HPLC, NMR and PSD.
• Experience within the pharmaceutical/biotechnology industry or CDMO industry is required. Experience in both is desirable, but not required.
• Proven track record meeting aggressive targets as related to safe, timely and successful projects.
• Good written, verbal and presentation skills.
• Strong communication, organization, and planning skills.
• Ability to prioritize and manage numerous activities simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.

Job Summary:

We are seeking an experienced Environmental, Health, and Safety (EHS) specialist to lead our EHS initiatives within our CDMO operations. The ideal candidate will assist in activities to ensure compliance with local, state, and federal regulations while fostering a culture of safety and environmental stewardship. This role requires a proactive approach to risk management, incident investigation, and the development of training programs to promote safety awareness among all employees.

Key Responsibilities:

• Compliance Culture: Foster a culture of compliance with environmental, health, and safety regulations at federal and state levels, including hazardous waste management, air resource regulations, the Right-to-Know Act, emergency preparedness, and X-ray compliance.
• Regulatory Adherence: Assist in activities to ensure that the facilities meet all legal and regulatory requirements, including licensing requirements.
• Assist in submitting reports as required by the EPA, NJDEP, and OSHA for all J-Star sites in support of regulated and licensed activities.
• Inspections Audit Management: Lead inspections by regulatory agencies (EPA, NJDEP, DEA, OSHA) and the audits from client. Ensure inspection readiness with well-maintained records, SOPs, training records, and other required documentation. Facilitate meetings with inspecting officials/client auditors as needed.
• Process Safety Evaluations: Participate and assist in the safety evaluation of new and ongoing projects, providing guidance for safe operations and developing strategies to meet EHS standards while adhering to project timelines.
• Communication with Corporate EHS: Establish open communication channels with corporate EHS headquarters in Porton, China, to align EHS programs within legal and regulatory boundaries.
• Emergency Plans: Assist in developing, updating and filing emergency response plans with the appropriate agencies as required by law.
• SOPs and Training Material: Assist in drafting and updating relevant Standard Operating Procedures (SOPs) and training materials in EHS. Conduct relevant training to employees on EHS policies and regulatory guidance.
• Safety Inspections: Conduct regular safety inspections of laboratories across all J-Star sites to ensure compliance with safety and chemical hygiene standards. File lab inspection summary reports in an accessible location.
• Cost Evaluations: Periodically evaluate hazardous waste management costs and identify creative strategies to reduce expenses through employee training, waste stream consolidation, or negotiations with waste handling companies.
• Emergency Response: Respond to emergencies, including chemical spills, equipment failures, and employee injuries. Keep HR, site heads, and relevant management informed of serious EHS incidents.
• Safety Audits and Risk Assessments: Conduct regular safety audits and risk assessments to identify hazards and implement corrective actions in collaboration with other departments.
• Incident Investigation: Participate in the investigations of accidents and near-misses, determining root causes and implementing preventive measures. Maintain accurate records of incidents and prepare reports for management and regulatory agencies.
• Hazardous waste management: The candidate will be active in hazardous waste management at several sites including collection, storage, record-keeping, and disposal activities. RCRA and DOT certification for hazardous material management will be

Qualifications:

• Bachelor’s degree in environmental science, Occupational Health, Safety, or a related field.
• Experience preferred in EHS, preferably in a manufacturing or CDMO environment.
• Knowledge of applicable EHS regulations (OSHA, EPA, etc.) and industry standards.
• Laboratory experience preferred.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• The ideal candidate will need to have the required RCRA and DOT certification for hazardous waste activities, or they will need to complete training for the required certifications.
• Certification (e.g., CSP, CIH, CHMM,) is a plus.

Job Summary:

We are seeking a highly skilled and motivated Facility Operations Engineer with expertise in cGMP equipment commissioning and qualification to join our dynamic team in the Contract Development and Manufacturing Organization (CDMO) industry. The successful candidate will be responsible for overseeing and executing the start-up, commissioning, qualification, and validation processes of our NJ manufacturing facilities and equipment to ensure compliance with regulatory standards and internal quality requirements.

Key Responsibilities:

• Commissioning and Qualification:
  • Lead the timely execution of commissioning and qualification (C&Q) activities for new and existing facility systems, equipment, utilities, and related computerized systems, ensuring they meet design specifications, regulatory requirements, and User Requirement Specification (URS).
  • Develop, review, and approve commissioning and qualification protocols and reports.
  • Coordinate with cross-functional teams, including engineering, EHS, quality assurance, maintenance, third-party vendors and operations, to ensure timely and successful execution of C&Q activities including training.
• Compliance and Documentation:
  • Ensure all commissioning and qualification activities adhere to industry standards, cGMP (current Good Manufacturing Practices), and company policies.
  • Maintain accurate and comprehensive documentation of all C&Q activities, including deviations, resolutions, and change controls.
  • Prepare and present C&Q activities and documentation for regulatory inspections and audits.
  • Overall site administrator to implement and maintain a new validated CMMS system for lifecycle management of equipment and report on key department metrics for EHS, PM/Calibration program schedule adherence and regulatory compliance.
• Project Management:
  • Manage and oversee C&Q projects, including scheduling, resource allocation, and budget management.
  • Develop calibration and PM procedures for CMMS system.
  • Identify and mitigate risks associated with commissioning and qualification processes.
  • Collaborate with project teams to ensure seamless integration of C&Q activities with overall project timelines and deliverables.
• Continuous Improvement:
  • Identify opportunities for process improvements and implement best practices to enhance C&Q efficiency and effectiveness.
  • Stay current with industry trends, regulations, and technological advancements to ensure the company remains at the forefront of facility operations and compliance.
• Troubleshooting and Support:
  • Provide technical support and troubleshooting for facility systems and equipment during and after commissioning and qualification.
  • Address and resolve any issues or non-conformances that arise during and after C&Q activities.
  • Assist in tracking completion and review of maintenance and calibration activities that are related to quality events, CAPA’s, and Out of Tolerance (OOT) events.
  • General statement of other projects as assigned by Facility Director.

Qualifications:

• Education: Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field) or equivalent experience.
• Experience: Minimum of 3-5 years of experience in facility operations, commissioning, and qualification within the CDMO or pharmaceutical industry.
• Technical Skills:
  • Strong knowledge of commissioning and qualification processes (ISPE C&Q 2nd edition), GMP guidelines, and regulatory requirements.
  • Proficiency in using commissioning and qualification software and tools (e.g. Microsoft Office).
  • Experience with HVAC, Building Automation Systems (BAS) Carrier i-Vu, Blue Mountain CMMS system, utility systems, cGMP cleanroom environments, and manufacturing equipment.
  • Travel between Cranbury NJ and South Plainfield NJ sites may be required based on project assignments.
  • Physical Requirements: Lifting, climbing, outside weather conditions, Hot/Cold, Working around labs and chemicals, plant environment.

Job Summary:

We are seeking a highly motivated and skilled Process Chemist to join our Process R&D Department at Porton J-STAR. In this role, you will be responsible for the development, optimization, and scaling of chemical processes for pharmaceutical production. You will collaborate with cross-functional teams to ensure that our processes are efficient, cost-effective, and compliant with regulatory standards. This job description applies to activities and responsibilities associated with the process chemistry development group and support of GMP Operations.

Responsibilities:

• Follow existing synthetic routes, making processing improvements where necessary, while conducting multi-step organic synthesis
• Plan and organize routine operations to maximize production output.
• Design novel synthetic routes and carry out multi-step organic synthesis.
• Operate simple open access HPLC/UV, LC/MS, MS, NMR, GC/MS, and other analytical instruments required to monitor reaction processes.
• Consult with management, the Analytical Department, the Director of GMP Operations and others on issues concerning experiments prior to and during GMP production.
• Accurately make and check calculations, prepare raw materials, reagents and solutions in accordance with company SOP’s.
• Faithfully record procedures and results in Batch Records or Solution Preparation Forms, notebooks, or other appropriate forms in an organized manner as dictated by departmental SOP and GMP regulations.
• Write reports on research as required.
• Promote compliance with cGMP regulations. Attend GMP training sessions.
• Support management and maintenance of the SOP and Document Control system.
• Work with clients to develop material release tests and specifications for materials supplied by J STAR.
• Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, GMP Operations and Quality Control.
• Conduct process chemistry R&D for clients as an individual contributor, which includes, but is not limited to, research on synthetic routes to active pharmaceutical ingredients and chemical intermediates by route discovery, process optimization, safety evaluation, enabling technologies, high throughput screening and chemo/biocatalytic reaction discovery and optimization. This will include R&D under c-GLP and potentially under c-GMP conditions.
• Develop safe, timely and efficient chemical processes by using established, new and/or novel chemical methodologies and processes.
• Coordinate analytical chemistry methodology to process and/or catalysis discovery, development optimization and problem solving.
• Maintain an uncompromising focus on quality, documentation, confidentiality and scientific execution.
• Participate in idea generation for selective quotes/proposals to clients as well as successfully execute against accepted quotes.
• Initiate cross-department communication and develop coordinated R&D, processing schedules and deliverables
• Lead and contribute to scientific and technical discussions with co-workers and clients to plan, execute, resolve issues and problem solve.
• Communicate candidly, clearly and timely with clients, management and peers.
• Participate in weekly client updates as needed, prepare weekly reports, contribute to and lead campaign reports and participate in process chemistry technology transfer.
• Coordinate and author professional campaign reports, research summaries, and tech packages.
• Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs. Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices.
• Maintain a clean and well-organized hood, bench, glove-box and common work area that is free of clutter, excess chemicals/samples. Advocate for these principals and positively influence others in this regard.

Qualifications:

• Required PhD degree in Organic Chemistry.
• Proven track record meeting aggressive targets as related to safe, timely and successful synthetic organic chemistry projects.
• Knowledge and experience base of working in a c-GMP environment is preferable, but not required
• Excellent written, verbal and presentation skills.
• Experience in small molecule drug development is preferable, but not required.
• Track record of scientific success as measured by publications and presentations.
• Ability to prioritize and manage numerous activities simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.

Job Summary:

We are seeking a highly motivated Research Scientist to join our Analytical R&D and QC department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a strong background in analytical chemistry and experience in method development, validation, and quality control testing.

Key Responsibilities:

• Conduct analytical method development and validation independently.
• Troubleshoot analytical methods as needed and gain more experience in the related area.
• Conduct release testing for GMP regulatory starting materials, intermediates, and final APIs.
• Conduct testing for stability studies and cleaning verification.
• Review test data to ensure completion and accuracy.
• Write raw material test procedures as needed under supervision.
• Write SOPs and protocols as needed under supervision.
• Write instrument operating, maintenance, and qualification/calibration procedures as needed.
• Participate in OOS and deviation investigations, as needed.
• Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC/AD.
• Troubleshoot and maintain analytical instruments. Ensure that instrument calibration and qualification intervals are current.

Qualifications:

• BS, MS, or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related field.
• 3+ years of experience in analytical R&D and/or QC within the pharmaceutical or CDMO industry.
• Strong knowledge of analytical techniques, including HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
• Familiarity with method validation protocols and regulatory requirements.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Proficient in data analysis software and laboratory information management systems (LIMS).

Job Summary:

We are seeking a detail-oriented and motivated GMP Operations Scientist to join our South Plainfield site Kilo Lab GMP/Non GMP department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a strong background in GMP processes, solid knowledge of scale-up operations, and experience in pharmaceutical production.

Key Responsibilities:

• GMP Operations: Execute and oversee GMP operations in the Kilo Lab, including the preparation, execution, and documentation of batch records for the production of intermediates and active pharmaceutical ingredients (APIs).
• Scale-Up Activities: Support the scale-up of processes from laboratory to kilo scale, ensuring compliance with regulatory standards and internal quality requirements.
• Process Optimization: Collaborate with cross-functional teams to identify opportunities for process optimization and efficiency improvements in production.
• Quality Assurance: Ensure all activities adhere to GMP guidelines and SOPs, maintaining a high standard of quality throughout the manufacturing process.
• Data Management: Document and analyze production data, preparing comprehensive reports and summaries for internal and external stakeholders.
• Troubleshooting: Identify and resolve operational issues, implementing corrective and preventive actions as necessary.
• Training and Development: Mentor and train junior staff on GMP practices, safety protocols, and operational procedures.
• Regulatory Compliance: Participate in audits and inspections, ensuring that all GMP operations meet regulatory requirements.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 3+ years of experience in GMP operations within the pharmaceutical or CDMO industry, specifically in a kilo lab setting.
• Strong understanding of GMP regulations and industry best practices.
• Experience with process scale-up and equipment used in kilo lab operations (e.g., reactors, filtration systems).
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork skills, with the ability to collaborate effectively across departments.
• Proficient in data analysis and laboratory information management systems (LIMS).

Job Summary:

We are seeking an experienced Logistics Specialist to join our dynamic team within our CDMO operations. The Logistics Specialist will be ensuring that all aspects of logistics operations are managed effectively, from inventory control to shipping, and collaborating with cross-functional teams, the Logistics Specialist plays a vital role in maintaining efficient operations within a CDMO environment. This position also requires a strong focus on regulatory compliance, safety protocols, and continuous improvement within the logistics function.

The ideal candidate will have a strong understanding of logistics operations within the pharmaceutical manufacturing industry, including regulatory requirements, supply chain optimization, inventory management, and the ability to manage complex shipments with a focus on cost and quality.

Key Responsibilities:

• Shipment Receipt and Order Confirmation:
  • Confirm the receipt of shipments against purchase orders to ensure accurate deliveries.
  • Review shipment documents for accuracy and match with corresponding purchase orders and inventory records.
• Inventory Management and Tracking:
  • Oversee all aspects of chemical, solvent, and consumable inventory management, ensuring compliance with company standards and regulations.
  • Utilize accounting, barcoding, and/or database systems to track inventory levels and facilitate accurate inventory management.
  • Establish and maintain an inventory management system for consumables with clearly defined maximum and minimum stock levels.
  • Conduct regular inventory checks to ensure accurate stock counts and that inventory requirements are met on time.
• Consumable Stock Levels and Database Maintenance:
  • Ensure that the pre-defined minimum and maximum levels for all consumables are maintained and that stock is replenished as needed.
  • Maintain a precise and updated database for consumable items, including accurate pricing and product specifications.
  • Return surplus consumables or chemicals to inventory and update the database accordingly.
• Inventory Audits and Reports:
  • Coordinate and participate in periodic physical inventory counts and reconcile discrepancies between physical stock and system records.
  • Run regular reports related to inventory status for supervisors and management, highlighting any issues or trends that need attention.
• Collaborate on Inventory Definition and Reporting:
  • Partner with internal stakeholders and cross-functional teams to define inventory items, their attributes, and the quantities required for operations.
  • Work closely with relevant departments to ensure that inventory management meets production and operational needs.
• Supplier and Vendor Relationship Management:
  • Provide input on the selection, negotiation, and relationship management of consumable suppliers, ensuring competitive pricing and reliable supply.
  • Support Procurement-related activities, including executing operational expenditure (OPEX) orders and assisting with vendor negotiations for discounts and service contracts.
• Shipping and Receiving:
  • Coordinate and oversee all aspects of shipping and receiving, ensuring shipments are picked up by the specified carrier according to guidelines and safety protocols.
  • Ensure compliance with internal shipping and receiving procedures, safety guidelines, and Department of Transportation (DOT) regulations.
  • Maintain an adequate supply of shipping materials and packaging materials to support daily logistics operations.
  • Track and record all shipping activities, costs, and related information in the appropriate database.
• Collaboration with Logistics Teams:
  • Work closely with other Logistics team members to harmonize activities, share best practices, and ensure smooth operations across the site.
  • Provide continuous support to Site Administrators, the Facility Operations Manager, and the Facility Site Lead on logistics-related matters.
• Safety and Compliance:
  • Maintain a clean and organized work environment, adhering to safety regulations and company policies.
  • Support Hazardous Waste Management activities, ensuring proper handling, labeling, storage, and disposal of hazardous materials in compliance with regulations.
  • Ensure all hazardous waste is properly documented, including maintaining the Hazardous Waste Manifest and supporting pick-up schedules with waste management vendors.
  • Conduct regular inspections of hazardous waste areas to ensure compliance with NJDEP (New Jersey Department of Environmental Protection) requirements and maintain inspection records.
• Training and Development:
  • Maintain updated DOT training records and ensure compliance with all applicable training and certification requirements.
  • Support ongoing professional development and training related to logistics, safety, and regulatory compliance.
• Communication and Stakeholder Support:
  • Provide timely and professional communication to internal teams, clients, and external stakeholders regarding logistics operations, issues, and updates.
  • Assist in resolving logistics-related challenges and proactively address any supply chain issues as they arise.

Qualifications:

• Bachelor’s degree in supply chain management, Logistics, Business Administration, or a related field. Relevant certifications (e.g., APICS, CLTD) are a plus.
• Minimum of 2-4 years of experience in logistics, supply chain management, or a similar role, preferably in the pharmaceutical, biotechnology, or CDMO industries.
• Strong organizational and time-management skills with the ability to manage multiple priorities and deadlines.
• Excellent communication and interpersonal skills, with the ability to work cross-functionally and with external partners.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Analytical mindset with the ability to identify and implement process improvements.
• Knowledge of international shipping procedures, customs regulations, and trade compliance is desirable.