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Job Description Job Summary: We are looking for a Warehouse Helper to join our team at a Contract Development and Manufacturing Organization (CDMO)/Contract Research Organization (CRO) and Kilo Lab facility. The Warehouse Helper will be responsible for assisting in various tasks related to warehouse operations in a pharmaceutical environment. Qualifications: • High school diploma or equivalent, • Prior experience in a warehouse setting preferred, • Basic knowledge of inventory management procedures, • Ability to follow safety guidelines and work procedures, • Strong attention to detail, • Good communication skills Responsibilities: • Assist in receiving and storing incoming shipments, • Maintain inventory records and ensure accuracy in stock levels, • Prepare orders for shipment and load/unload delivery trucks, • Keep warehouse area clean and organized, • Follow safety guidelines and proper handling of materials, • Assist in conducting periodic inventory checks Physical Requirements: • Ability to lift and move heavy items (up to 50 lbs), • Stand, walk, bend, and lift for extended periods of time Work Environment: • Work in a warehouse setting within a pharmaceutical facility, • Exposure to various temperatures and noise levels Benefits: • Competitive pay, • Health insurance, • Retirement savings plan, • Paid time off, • Opportunities for growth and development within the organization

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. Job Scope: The position reports to the Warehouse Supervisor and will support warehouse raw material and finish products functions. Individuals in this role should be extremely detail oriented and possess good problem-solving skills. It is also expected that warehouse specialist has adequate physical strength to successfully unload shipments. Essential responsibilities: • Coordinate domestic and international shipments for raw materials, intermediates, drug substance, and drug product, • Manage freight forwarders and carriers; monitor shipment status and proactively resolve issues, • Prepare, review, and maintain shipping and customs documentation, • Support temperature-controlled, time-sensitive, and high-value shipments, • Ensure logistics activities comply with GMP/GDP requirements and internal SOPs, • Work closely with Manufacturing, QA, QC, Procurement, and Project teams to align shipment schedules, • Track logistics costs and support cost control and optimization initiatives Qualifications: • Bachelor's degree in supply chain, Logistics, Business, Life Sciences, or related field is preferred, • Approximately 5 years of logistics or supply chain experience, preferably within CDMO, biotech, pharma, or life sciences industries, • Solid experience with international shipping, customs clearance, and freight forwarder management, • Familiarity with regulated environments (GMP/GDP), • Strong coordination, communication, and problem-solving skills, • Detail-oriented with strong documentation discipline, • Ability to manage multiple shipments and priorities independently, • Proficiency in ERP systems and Microsoft Excel Please note that this role is a full-time onsite role in Pennington, New Jersey. The estimated Pay range for the role is $65000 - $75000 annually #LW #PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Hybrid in Greater Princeton, NJ Join my client—a fast-growing, mission-driven biopharma organization—where clinical excellence meets sharp financial strategy. As a Clinical Budgeting & Contract Analyst, you’ll sit at the nerve center of Clinical Operations, transforming complex protocols into smart, scalable budgets and negotiating agreements that keep trials moving efficiently and compliantly. If you thrive at the intersection of science, operations, and financial precision, this role becomes your launchpad. Why You Should Apply • Drive budget + contract strategy across cutting-edge clinical programs, • High-visibility role partnering with Clinical Ops, Finance, Project Management & Legal, • Hybrid flexibility in the Greater Princeton region, • Impactful work in a nimble, growing, patient-focused biotech environment, • Growth path into Clinical Finance, Vendor Management, or Project Leadership What You’ll Be Doing • Draft, review & negotiate MSAs, CTAs, Work Orders, Amendments, NDAs, • Build detailed CRO, site, vendor, lab, imaging, and pass-through budgets, • Map protocol procedures to cost drivers, visit schedules & operational requirements, • Validate and reconcile invoices; ensure milestone-driven financial accuracy, • Partner cross-functionally to align contract terms, risk language & deliverables, • Maintain audit-ready documentation and support inspection readiness, • Drive contracting standardization, templates & process improvements About You • 2–6 years in clinical budgeting, contracting, vendor management, or CRO finance, • Strong understanding of trial operations, cost drivers & ICH-GCP, • Skilled negotiator with sharp analytical and cross-functional communication skills, • Bachelor’s in Finance, Business, Life Sciences or related discipline How To Apply Send your resume to ava@scientificsearch.com and reference Job #19784.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Title: SAP Engineer(MM/WM/PP/SD) Location: Hopewell, NJ The estimated salary range for this role is $110,000 - $120,000 depending on experience. Position Summary ProBio is seeking an experienced SAP professional with strong hands-on knowledge of the SAP MM/WM/PP/SD modules to advance our SAP application landscape. The role requires deep functional expertise and business acumen, with proven experience in WM and PP being highly desirable. Key Responsibilities (listed by importance, ≤10 items) • Daily operation, maintenance, and administration of SAP MM/WM/PP/SD modules., • Lead or support rollout projects and continuous-improvement initiatives related to MM/WM/PP/SD., • Monitor master data integrity and business transactions within MM/WM/PP/SD; ensure compliance with SOPs., • Gather business requirements, draft functional specifications, organize testing (UT, IT, UAT), and track post-go-live adoption. Qualifications • Education: Bachelor's degree, • Major: Any discipline., • Industry: Life-science or manufacturing preferred., • Experience: Minimum 3 years of SAP MM/WM/PP/SD operation or implementation experience in one or more modules., • Core Competencies:, • Able to independently perform customizing for any of MM/WM/PP/SD modules., • SAP certification, SAP CSV validation experience, or ABAP development skills are advantages., • Knowledge: Solid understanding of end-to-end business processes and key configuration points for any of MM/WM/PP/SD modules., • Language: Fluent in Chinese and English (reading, writing, speaking). #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Procurement Specialist - Temp to Hire (This is a Temporary position initially with a potential to be converted to Full time opportunity) About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. Job Scope: The position will report to the Head of US Site Operations Department and requires close collaboration with production teams and cross-functional departments is essential to address procurement needs, while maintaining communication with vendors to manage risks and opportunities. The role also includes managing compliance, audits, and providing necessary documentation. Essential responsibilities: Responsible for CAPEX & facility maintenance service procurement. Responsible for general procurement/purchasing and cost reduction initiatives. Internal/External customer focus to address issues and to collaborate assigned projects. Implement negotiations and contracts, collaborating with the relevant partners to optimize terms, cost and deliverables, ensuring the quality of service/ goods, and mitigating risks. Maintain relationships with key functional managers and their teams to ensure understanding of their needs and to facilitate the appropriate level of challenge. Responsible for MSA, annual contract, and bid management. Comply with global procure-to-pay standard operating procedures, policies and file system. Review supplier performance against contracted obligations, service levels and business requirements. Maintain material code and other configuration in ERP/SAP, S2P programs and others. Required Qualifications, Knowledge & Skills: A minimum of a Bachelor's degree is required for this position. Knowledge and understanding of overall supply chain and procurement cycle Strong communication, influencing, collaboration skills. Strong contract management and negotiations skills Strong Project and change management capabilities. Strong verbal and written communication skill with ability to expertly present sophisticated information. Ability to work independently with continuous performance integrity within continuous improvement working environment Excellent computer skills with Excel, Word, PowerPoint, and familiar with ERP/SAP system. Experience in working with multi-cultural teams. #LW #PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. Job Scope: This position is responsible for coordinating and overseeing facility outside services, engineering and construction capital projects for GXP & non-GMP facilities in New Jersey. This role will focus on working with external engineering design firms, construction contractors, landlords, and government offices, as well as all internal departments. Essential responsibilities: • Manage multiple facility outside services, engineering and construction projects ranging from $0.05MM to $30MM at any given time., • Direct day-to-day activities of project team to achieve the following for each project:, • Log and track action items through project lifecycle., • Bid, award, and select engineering firms, construction firms, equipment vendors, CQV consultants, and service contractors., • Ensure that user requirement specifications are appropriately met through high quality project deliverables., • Develop and maintain a project schedule to foster accountability and note staffing requirements., • Manage project capital budget, ensuring on-time and under-budget project completion. Ensure that POs and contracts are issued within budget and company standards., • Review and process change orders in accordance with contract requirements., • Prepare project updates and budget release presentations to be provided to upper management teams., • Build partnering relationships with project executives, landlords, contractors, and consultants., • Host Gemba Walks and track observations correction to fulfill continuous site improvement., • Execute and manage site-wide controlled drawings program. Complete physical verification, redline, correction, and control of drawings required for qualification activities., • Establish and maintain site security program. Assign new badges, control security clearances, and rectify security incidents. Qualifications • Bachelor's or advanced degree in Construction Management, Mechanical Engineering, Biomedical Engineering, or other Engineering capacity., • Strength in managing facility & construction projects for facilities in the pharmaceutical industry., • Experience in project management and engineering practices. PMP or similar project management certification is preferred., • Familiarity with estimating and bidding, • Experience in negotiating with landlord, government regulation offices, and engineering/construction contractors., • Understanding of manufacturing processes for plasmid DNA and viral vectors in the cell & gene therapy industry., • Possess strong written and communication skills., • Proficient in Auto Cad & Microsoft Project highly desired. The estimated pay range for the role is between $100000 - $120000 depending on experience and skill set LW PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio: ProBio, a subsidiary of GenScript, has a one stop biopharmaceutical R&D and production platform, mainly dedicated to cell and gene therapy (CGT) drugs, vaccine and biopharmaceutical discovery, antibody protein Provides end-to-end CDMO services from target development to commercial production. GenScript has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers. Since October 2017, it has assisted customers in the United States, Europe, Asia Pacific and other regions to obtain more than 50 IND approvals. Job Scope: The Automation Engineer is responsible for administration and management of the site's automation systems, including Supervisory Control and Data Acquisition (SCADA) system, PLCs, notification systems and computerized QC Lab instruments. The scope of the responsibilities includes the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems. The incumbent works cross-functionally with internal departments including Information Technology, Manufacturing, Facilities & Engineering, Quality Control, and Quality Assurance, as well as external resources/vendors to maintain the site's automation systems. The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Responsibilities: • Work closely with stakeholders to understand and fulfill system requirements and improve the quality of automated processes., • Collaborate with stakeholders, including Area Managers, System Owners, and System Users to ensure successful onboarding, use and retirement of automation systems., • Develop appropriate Validation Protocols, Reports, and Lifecycle documents., • Execute Validation Protocols and collecting test evidence., • Create and improve Administration SOPs of automation systems, • Monitor integrity, availability, performance and operability of automation systems., • Identify, investigate and correct technical issues, including performing root cause analysis for production errors., • Make adjustments, enhancements and applying patches or upgrades as required for automation systems, while adhering to the Change Control process., • Understand network operations, system operations, and Cloud-based systems., • Administer user access management., • Ensure compliance with applicable regulatory standards., • Maintain up-to-date knowledge of current technology trends, programming languages, and automation best practices for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and QC instruments., • Author appropriate Change Controls and Test Scripts and serve as the Subject Matter Expert for applicable technical changes in automation systems., • Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT)., • Liaison with Business, Quality Assurance, Managed Services, and IT to coordinate the Change Request processes, • Training:, • cGxP, • Applicable Corporate and Departmental Directives, Policies, and Procedures, • Good Manufacturing Practices and Good Documentation Practices, • Automation Control and Data Acquisition, • EHS, • Lab/Biological Safety, • Gowning Qualifications: • Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, various Repligen and Thermo Scientific instruments is a plus., • Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 5-7 years of related experience that provides direct scientific knowledge of automation systems operation and validation principles for computerized biologics production systems., • Proven experience as an IT Automation Engineer or similar role., • Direct knowledge of the biologics process equipment, SCADA/control systems, and supporting IT networking infrastructure., • Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, SCADA system architecture, Biotech Process Equipment/Systems., • Proficient in use of electronic systems, such as Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS)., • Knowledge of domestic / international regulatory guidelines / compendia and industry standards (FDA, ICH, USP and EMEA guidelines) for validation of computerized equipment and automation systems, including but not limited to 21 CFR Part 11, EU Eudralex Annex 11 and GAMP 5., • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines., • Comfort with collaboration, open communication, reaching across functional borders and being proactive., • A strong focus on business outcomes., • Ability to prioritize and juggle multiple concurrent projects and day-to-day requests Please note that this role is based fully onsite in Pennington, New Jersey. The estimated salary range is $90,000 - $120,000 annually. #PB #LW GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionDescription: Responsibilities: • Lead operational execution of assigned clinical trials under both:, • In-house managed models (direct CRA/site oversight), and, • Outsourced models (full-service or functional CRO partnerships), • Ensure consistent application of sponsor SOPs regardless of delivery model, • Drive study start-up, enrollment, and close-out milestones across all regions, • Directly manage CRAs and/or Lead CRAs assigned to in-house managed studies, • Provide functional oversight of IHCRAs - Assign, prioritize, and track IHCRA work activities, including: o Site document review and tracking o Remote monitoring support and follow-up o Query and action item tracking o TMF/eTMF filing support and completeness checks • Review IHCRA outputs for quality, timeliness, and compliance, • Provide feedback, coaching, and training input to IHCRAs in collaboration with line managers, • Assign sites, review monitoring plans, and ensure adequate site coverage, • Review monitoring visit reports, follow-up letters, and issue resolution, • Coach and mentor CRAs to ensure monitoring quality and compliance, • Provide sponsor oversight of CROs, vendors, and functional service providers, • Review and approve CRO deliverables (monitoring plans, reports, metrics, TMF status), • Ensure CRO performance aligns with contracted scope, KPIs, timelines, and quality standards, • Lead governance meetings, performance reviews, and escalation management, • Ensure clear documentation of sponsor oversight activities per ICH E6(R2/R3), • Experience supporting and overseeing both Risk-Based Monitoring (RBM) strategies and traditional 100% SDV monitoring models, as appropriate to study design, risk profile, and regulatory expectations, • Ability to transition studies between RBM and 100% SDV approaches based on protocol requirements, inspection feedback, or sponsor risk assessments, • Oversight of monitoring plans to ensure: o Appropriate SDV/SDR levels o Centralized monitoring outputs are reviewed and actioned o On-site, remote, and hybrid monitoring approaches are appropriately applied • Oversee protocol deviations, CAPAs, and quality issues, • Identify operational risks early and implement mitigation strategies, • Act as escalation point for complex site, CRA, or CRO issues, • Partner with sites to support enrollment, retention, and protocol adherence, • Ensure studies are inspection-ready at all times, • Support and participate in regulatory inspections and audits (FDA, EMA, Health Authorities), • Ensure timely TMF completeness and eTMF oversight (in-house and CRO-maintained TMFs), • Collaborate with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, and Supply Chain, • Provide operational input into protocols, ICFs, feasibility, and country/site strategy, • Support investigator meetings, site trainings, and study communications, • Provide regular study status updates to senior management, • Maintain oversight trackers, risk logs, issue logs, and KPI dashboards, • Ensure accurate documentation of decisions, deviations, and actions, • Any other duties as assigned by Supervisor.Requirements: Qualifications Education • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (required), • Advanced degree preferred Experience · 8+ years of clinical research experience, including management of both in-house and outsourced trials, with 6+ years of onsite monitoring CRA experience, including people management and CRO oversight exposure • Experience managing global or multi-regional Phase I–III trials preferred Core Competencies & Skills • Strong understanding of sponsor oversight responsibilities under ICH-GCP, • Hands-on experience with both direct CRA management and CRO governance, • Expertise in RBM, centralized monitoring, and quality risk management, • Strong leadership, communication, and stakeholder management skills, • Ability to manage multiple studies and vendors simultaneously, • Proficiency with CTMS, eTMF, and clinical systems Preferred Experience • Sponsor-side experience in biotech or pharmaceutical companies, • Experience transitioning studies between in-house and outsourced models, • Experience in complex or rare disease trials, • Prior inspection support experience Travel Up to 60% travel- Focused on co-monitoring, audit readiness visits, CRO oversight visits, inspections

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Title: SAP Engineer(MM/WM/PP/SD) Location: Pennington, NJ The estimated salary range for this role is $110,000 - $120,000 depending on experience. Position Summary ProBio is seeking an experienced SAP professional with strong hands-on knowledge of the SAP MM/WM/PP/SD modules to advance our SAP application landscape. The role requires deep functional expertise and business acumen, with proven experience in WM and PP being highly desirable. Key Responsibilities (listed by importance, ≤10 items) • Daily operation, maintenance, and administration of SAP MM/WM/PP/SD modules., • Lead or support rollout projects and continuous-improvement initiatives related to MM/WM/PP/SD., • Monitor master data integrity and business transactions within MM/WM/PP/SD; ensure compliance with SOPs., • Gather business requirements, draft functional specifications, organize testing (UT, IT, UAT), and track post-go-live adoption. Qualifications • Education: Bachelor's degree, • Major: Any discipline., • Industry: Life-science or manufacturing preferred., • Experience: Minimum 3 years of SAP MM/WM/PP/SD operation or implementation experience in one or more modules., • Core Competencies:, • Able to independently perform customizing for any of MM/WM/PP/SD modules., • SAP certification, SAP CSV validation experience, or ABAP development skills are advantages., • Knowledge: Solid understanding of end-to-end business processes and key configuration points for any of MM/WM/PP/SD modules., • Language: Fluent in Chinese and English (reading, writing, speaking). #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionDescription: Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. RESPONSIBILITIES: GCP Compliance Oversight · Ensure all clinical trials are conducted in compliance with ICH-GCP, regulatory requirements, and sponsor SOPs. · Provide GCP oversight across Phase I–IV clinical trials conducted globally. · Interpret and implement GCP regulations, guidance documents, and industry best practices. · Monitor adherence to protocol, regulatory commitments, and ethical standards. Quality Management & Risk Oversight · Develop and implement Quality Management Systems (QMS) related to clinical research. · Support implementation of Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) strategies. · Review Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk logs. · Identify systemic quality risks and recommend corrective actions. Audit & Inspection Readiness · Plan, coordinate, or support GCP audits including: o Investigator site audits o Vendor audits o Internal process audits · Support preparation for regulatory inspections (FDA, EMA, MHRA, etc.). · Manage inspection readiness activities, documentation review, and mock inspections. CAPA Management · Oversee Corrective and Preventive Action (CAPA) processes related to GCP findings. · Investigate protocol deviations, compliance issues, and audit findings. · Track CAPA implementation and effectiveness. · Ensure timely closure of audit observations. Clinical Trial Oversight · Provide independent quality oversight of CROs, vendors, and investigative sites. · Review key trial documents including: o Protocols o Monitoring plans o Data management plans o Safety reporting procedures · Ensure appropriate sponsor oversight of outsourced activities. (For outsourced projects) SOP Development and Maintenance · Develop, review, and maintain clinical SOPs, work instructions, and quality procedures. · Ensure procedures align with: o ICH E6(R2)/E6(R3) o Regulatory requirements o Company quality systems. Training and GCP Education · Develop and deliver GCP training programs for clinical teams. · Ensure training compliance across clinical staff and vendors. · Provide guidance on GCP interpretation and best practices. TMF and Documentation Compliance · Ensure compliance with Trial Master File (TMF) requirements. · Conduct TMF health checks and quality reviews. · Ensure essential documents are complete, accurate, and inspection ready. Vendor and CRO Oversight · Evaluate CRO and vendor quality systems. · Participate in vendor qualification and oversight activities. · Review vendor performance and compliance metrics. Regulatory & Ethical Compliance · Ensure compliance with: o Institutional Review Boards (IRB)/Ethics Committees o Regulatory submissions and approvals o Safety reporting requirements (SAE/SUSAR). Continuous Improvement · Identify opportunities to improve clinical processes and quality systems. · Implement lessons learned and best practices across programs. · Support quality culture across clinical teams. Requirements: QUALIFICATIONS Bachelors or Advanced degree in life sciences, pharmacy, or medicine. 5+ years of experience in quality and clinical development in pharma space with involvement in regulated clinical trials, clinical safety, pharmacovigilance. Strong knowledge of ICH-GCP, FDA, EMA regulations. Experience with audits, inspections, and quality systems. Prior experience with CRO oversight and global trials. EDUCATION & EXPERIENCE: Advanced degree in life sciences, pharmacy, or medicine preferred.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About Probio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. Position Summary (Sr.) EHS Manager is responsible for establishing, leading, and continuously improving the EHS program for a single-site biologics and GCT CDMO in New Jersey, covering process development (PD) through GMP manufacturing of plasmid DNA, viral vectors and biologics. This role ensures full compliance with federal, state, and local regulations, supports client and corporate requirements, and drives a strong safety culture across labs, pilot, and GMP suites. Key Responsibilities • Own and manage the site EHS Management System in compliance with OSHA, EPA, DOT, NFPA, and NJ state/local regulations., • Develop, maintain, and implement EHS policies, procedures, and programs., • Lead environmental compliance: hazardous/universal waste, wastewater, air emissions, Tier II/SARA reporting, and NJDEP permits., • Lead or support the Biosafety Officer function; oversee biosafety programs for BSL-2 / BSL-2+ plasmid and lentiviral operations., • Ensure safe handling and control of viral vectors, biological materials, chemicals, cryogens (LN2), and compressed gases., • Plan and coordinate industrial hygiene assessments and occupational health programs (e.g., respiratory protection, medical surveillance)., • Lead EHS risk assessments, incident/near-miss investigations, root cause analysis, and CAPA; track and report EHS KPIs., • Deliver EHS onboarding and refresher training; maintain strong floor presence and coach line leadership., • Represent EHS during client audits, regulatory inspections, and site visits; support EHS sections of quality/technical agreements., • Own the site Emergency Response Plan and coordinate drills and external responder engagement. Qualifications • Bachelor's or above degree in Environmental Science, Occupational Health & Safety, Industrial Hygiene, Engineering, Biology, or related field required., • 10+ years of EHS experience with site-level responsibility in biotech/pharma/CDMO or similar regulated environment., • Strongly preferred: experience with biologics or viral vector operations (plasmid DNA, lentivirus, BSL-2 labs, GMP manufacturing)., • Solid knowledge of OSHA 29 CFR 1910, RCRA, basic CAA/CWA requirements, DOT HazMat; familiarity with biosafety standards (BMBL, NIH Guidelines)., • Preferred certifications: CSP, CIH, CHMM, RBP/CBSP or equivalent., • Proven ability to work cross-functionally, communicate clearly, and provide practical, operations-friendly EHS solutions in a fast-paced setting. The estimated salary range is $100,000 - $150,000, based on experience level. #LW PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017 Position Overview: The position reports to the Sr. Scientist, is ideally suited for a professional with extensive technical knowledge, and a proven track record of developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients. Responsibilities: • Support the set-up, development and maintenance of a GMP QC-Analytics Lab, • Generate and characterize engineered cell lines, including production of MCB and WCB for cell-based assay development., • Develop, optimize, and execute molecular and cellular assays to assess vector performance using qPCR/ddPCR based assay, Western blot, ELISA and Flow cytometry., • Independently plan, perform, analyze, and interpret experiments, present clear data summaries and recommendations to cross-functional teams and clients., • Prepare technical reports, study summaries, and presentation materials to support decision-making., • Collaborate closely with other teams in CMC and coordinate cross-functional activities to support tech transfer and CMC activities., • Drive continuous improvement by identifying and implementing new tools, technologies, and best practices in CGT CMC analytics., • Ensure compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements. Qualifications: • Ph.D. with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field., • Demonstrated hands-on experience in lentiviral vector release testing and characterization (required)., • Expertise in molecular and cell biology techniques, including qPCR, ddPCR, ELISA or DNA Sequencing/Analysis., • Hands-on experience with Western blotting and flow cytometry for protein and cell-based analyses., • Exposure to NGS-based methods for vector or genome characterization is a plus., • Working knowledge of Good Documentation Practices, data integrity, and ALCOA+ principles., • Strong problem-solving skills with the ability to work independently and collaboratively in a team environment., • Excellent interpersonal, verbal, and written communication skills., • Familiarity with regulatory requirements and guidance from agencies such as FDA and ICH; experience with EU Annex 1 and laboratory audits is a plus. Pay range is estimated between $80k - $110k based on skill set and experience. #PB #AH GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017 Job Scope The Senior Manager, Quality Operations is responsible for Manufacturing & QC Shop-Floor Quality, Batch Release, Document Control, and Training functions. He /She oversees the group responsible for quality functions related to Good Manufacturing Practices (GMP) and Phase-Appropriate compliance for both clinical and marketed Gene Therapy products and Plasmid DNA at the Hopewell manufacturing facility. He /She is expected to grow and develop the group commensurate with the business need. Essential Responsibilities: Lead Probio Quality Operations and Batch Release Program for Gene Therapy and Plasmid Manufacturing. This may include, but may not be limited to the following functions: • Develops procedures for and performs local batch disposition for Gene Therapy Drug Substance, Drug Product, MCB (Master Cell Bank), Plasmid and Finished goods manufactured at the Hopewell, NJ site., • Issues batch compliance documentation such as Certificates of Conformance/ Compliance / Quality (CoCs/COQs), Certificates of Analysis (CoAs), BSE/TSE Statements., • Develops and manages QA functions related to Cell Bank and Plasmid disposition, usage, and lifecycle., • Oversees ProBio QA Area Release/ Line Clearance Procedures and facility walkthroughs., • Oversees the QA approval of calibration reports for GMP equipment/instruments in Maximo, • Supports internal and external audits to assure compliance with GMP regulations., • Manages or performs QA "person-in-plant" type activities during cell bank receipt, manufacturing, filling, labeling, visual inspection, packaging, warehousing and shipping activities. Directs Document Control, Records Management & training activities for the Gene Therapy Manufacturing Site Activities. This may include, but may not be limited to the following functions: • Oversees Document control activities related to approval of local electronic documents such as SOPs, Standards, Forms, Work Instructions, Master Batch Records, and specifications., • Develops and implements local procedures for control of drug product label proofs, printed labels, and reconciliation of unused/damaged labels., • Manage Veeva Vault administration for all Veeva Vault applications., • Supports interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems., • Recommends Quality system changes to enhance overall job performance and Quality functions and partners with peers in overseeing the implementation of these changes. Qualifications: • Bachelor's degree in a scientific discipline and a minimum 7 years of experience in Quality or related role(s) in a pharmaceutical, biotechnology or related environment, and at least 3 of which have been in a CMC-focused Quality position., • Experience with Veeva Vault Quality Docs and Training, • Proficiency with Microsoft Office., • Excellent verbal and written communication skills., • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members., • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines., • Demonstrated knowledge of biologics, viral vector, and plasmid manufacturing and testing. The Pay range is estimated between $110000 - $150000, based on experience and skill set LW PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. Position Overview: The position reports to the Sr. QC Manager is ideally suited for a professional with extensive technical knowledge, and a proven track record of developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials and participating in the technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients. Responsibilities: • Apply knowledge of bio separation techniques to support method development, troubleshooting, and process characterization, • Support the establishment, development and optimization of Analytical Development (AD) and Quality Control (QC) laboratories to enable both Non-GMP and GMP testing•, • Design, develop, and execute analytical methods, including method development, method qualification/validation, technology transfer, and product testing., • Own method lifecycle management activities, including authoring and reviewing protocols, reports, and technical documentation., • Support procedure lifecycle activities, including authoring and reviewing Standard Operating Procedures (SOPs) and associated forms. Perform, • and interpret a broad range of analytical assays, including but not limited to UPLC/HPLC, CE-SDS, and analytical ultracentrifugation (AUC)., • Drive continuous improvement initiatives across AD and QC, identifying opportunities to enhance assay robustness, efficiency, and data quality., • Analyze complex datasets and effectively communicate results, observations, and recommendations to internal and external stakeholders, • Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams to support product and process advancement., • Perform other duties as assigned based on business needs, • Up to 15% traveling to support CDMO projects or business development activities. Qualifications: • Master's degree with 2+ years of relevant industry experience, or Bachelor's degree with 5+ years, or Ph.D. with relevant experience., • Degree in Chemistry, Biochemistry, Molecular Biology, or related scientific field; experience in gene and cell therapy is a plus., • Hands-on experience with analytical techniques such as UPLC/HPLC, CE-SDS and/or AUC; experience working with MALS and/or CAD detectors is a plus., • Experience executing assays in accordance with Standard Operating Procedures and protocols in a regulated or controlled environment., • Strong problem-solving skills with the ability to work independently and collaboratively in a fast-paced environment., • Familiar with principles of Good Documentation Practices, Data Integrity, and ALCOA+., • Strong interpersonal, verbal, and written communication skills., • Experience with Next-Generation Sequencing (NGS) is a plus., • Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus. Pay range is estimated between $80k - $110k based on skill set and experience. LW PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

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