Career at
J-STAR Research

Job Title: Research Scientist of Crystallization R&D

Department: Crystallization R&D

Location: Onsite, Cranbury NJ

Job Type: Full Time          

Position Reports to: Director or VP of Crystallization R&D

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 search for the right solid form and develop formulations to support preclinical studies including PK, PD, efficacy, tox studies. This role is also responsible for crystallization process development, with goals of controlling 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:

• Perform activities in phase-appropriate solid form screening & selection and solid-state characterization, such as powder X-ray diffraction, DSC, TGA, SEM, particle size, polarized light microscopy, moisture sorption analysis, solubility, dissolution and stability assessments.
• Understand solid form phase mapping of drug candidates to assist in crystallization process development
• Carry out experiments in preformulation and developability assessment.
• Conduct phase-appropriate crystallization process development for API and intermediates to meet critical quality attributes.
• Carry out rational design and control of drug substance physical properties through particle engineering technologies and drug substance-drug product coprocessing.
• Learn continuously and apply fundamentals of related instrumentation knowledge (automation, PAT), and simulation tools in effective crystallization process development, from experimental design to operation, data collection, result analysis and presentation.
• Implement new technologies, systems and ways of working to enhance both technical rigor and operational efficiency to better meet the demands of diverse drug developmental programs.
• Contribute weekly client updates, ensure weekly update and final reports submitted in a timely fashion.
• Prepare and submit final technical reports and documentation to clients in accordance with project timelines.
• Communicate candidly, clearly and timely with clients, management, peers and group members.
• Maintain a safe and clean laboratory environment, comply with cGMP procedures, and company policies.
• Contribute to the development, calibration, and maintenance of laboratory instruments and equipment to support crystallization and solid-state research.
• Maintain appropriate documentation (batch records and lab notebooks).
• Perform other relevant duties as assigned by the management team.

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.
• 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 Title: Drug ProductResearch Scientist

Department: Drug Product R&D

Location: Onsite, Cranbury NJ

Job Type: Full Time          

Position Reports to: Director/ head of Drug Product 

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 continuousimprovement.

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 Title: EH&S Manager

Location: Onsite, Cranbury & South Plainfield NJ  

Position Type: Full-Time 

Reports To: Director/VP

Job Summary:
We are seeking an experienced Environmental, Health, and Safety (EHS) Manager to lead our EHS initiatives within our CDMO operations. The ideal candidate will 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: Ensure that the facility meets all legal and regulatory requirements, including licensing conditions.
• Prepare and submit 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 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: Develop, update, and file emergency response plans with the appropriate agencies as required by law.
• SOPs and Training Material: Draft and update 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: Lead 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.
• • Develop, implement, maintain, and continuously improve site-wide EHS programs and procedures, including hazardous waste management, chemical hygiene, laboratory and facility safety, respiratory protection, contractor safety, lockout/tagout (LOTO), electrical and hot work safety, emergency response, radiation/X-ray safety, and HPAPI operations.
• Draft, revise, and maintain EHS-related Standard Operating Procedures (SOPs), policies, and training materials.
• Serve as the primary EHS representative for regulatory inspections, customer audits, and corporate compliance initiatives while partnering with Operations, Facilities, Engineering, Quality, HR, and Site Leadership to support safe and compliant operations.
• Oversee EHS risk management activities, including industrial hygiene assessments, chemical exposure evaluations, process safety reviews, workplace inspections, compliance audits, and hazard mitigation initiatives across laboratory, pilot plant, manufacturing, and facility operations.
• Lead and manage environmental compliance programs, including hazardous waste management, regulatory reporting, environmental permits, waste vendor oversight, and compliance with OSHA, EPA, NJDEP, RCRA, DOT, and other applicable regulations.

Qualifications:

• Bachelor’s or Master‘s degree in Chemistry, Environmental Science, Occupational Health & Safety, Industrial Hygiene, Chemical Engineering, Environmental Engineering, or a related field. Master’s degree preferred.
• Minimum of 5+ years of progressive EHS experience in pharmaceutical, biotechnology, chemical manufacturing, life sciences, or CDMO environments.
• Strong knowledge of OSHA, EPA, NJDEP, DEA, DOT, RCRA, and other applicable environmental, health, and safety regulations.
• Experience supporting laboratory, pilot plant, manufacturing, and GMP-regulated operations.
• Experience managing regulatory inspections, customer audits, incident investigations, and compliance programs.
• Strong analytical, problem-solving, organizational, and project management skills.
• Excellent communication and interpersonal skills, with the ability to influence and engage employees at all levels of the organization.
• Experience with industrial hygiene monitoring, hazardous waste management, emergency response planning, and process safety programs is highly preferred.
• Professional certifications such as CSP, CIH, CHMM, ASP, or equivalent are highly desirable.

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).