Role & responsibilities BE Electrical /Electronics/ Instrumentation: Responsible for monitoring of water system SCADA , Pretreatment water system , Purified water generation , WFI generation and distribution system , Pure steam generation and distribution system. Monitoring of EMS and BMS system To ensure differential pressures, temperature & Relative Humidity of classified areas within pre-determined limits. Supervise all vendor activities and verify all tests performed by them in clean room validation/variable refrigeration flow air conditioning systems. Authorized to review all documentation of HVAC activities in logbooks, log sheets, AHU filter cleaning records & FMS alarms summary, Qualification Documents of HVAC System. Responsible for AHU qualification / re-qualification & related documentation including in-house & out-sourced testing. Preparation / revision of SOPs for HVAC operations as well as GMP training related to HVAC. To initiate & filled the change control, Deviation & CAPA for HVAC section with coordination of QMS related to Projects. Responsible to Execution of Clean room and HVAC Project with Co-Ordination of Outsourced/Third party. Responsible for Purchase Requisition initiation for consumables. Managing communication with respective Outsourced/Third party vendors and provide support to all project and processes. Provide support to all Breakdown and preventive maintenance requests, Manage all communication and provide efficient feedback for all project activity To Provide Support to engineering department during the period of Plant Audit. To enrol engineering HVAC staff in all trainings in GMP and technical knowhow as and when it is conducted To follow Good Documentation Practices and Data Integrity requirements during any GxP Operation and recording at site. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. To ensure that, in case of any event of potential data breach, it shall be handled through SOP on Handling of Potential Data Integrity Observation. BE Mechanical: Responsible for monitoring of water system SCADA , Pretreatment water system , Purified water generation , WFI generation and distribution system , Pure steam generation and distribution system. Monitoring of EMS and BMS system To ensure differential pressures, temperature & Relative Humidity of classified areas within pre-determined limits. Supervise all vendor activities and verify all tests performed by them in clean room validation/variable refrigeration flow air conditioning systems. Authorized to review all documentation of HVAC activities in logbooks, log sheets, AHU filter cleaning records & FMS alarms summary, Qualification Documents of HVAC System. Responsible for AHU qualification / re-qualification & related documentation including in-house & out-sourced testing. Preparation / revision of SOPs for HVAC operations as well as GMP training related to HVAC. To initiate & filled the change control, Deviation & CAPA for HVAC section with coordination of QMS related to Projects. Responsible to Execution of Clean room and HVAC Project with Co-Ordination of Outsourced/Third party. Responsible for Purchase Requisition initiation for consumables. Managing communication with respective Outsourced/Third party vendors and provide support to all project and processes. Provide support to all Breakdown and preventive maintenance requests, Manage all communication and provide efficient feedback for all project activity To Provide Support to engineering department during the period of Plant Audit. To enrol engineering HVAC staff in all trainings in GMP and technical knowhow as and when it is conducted To follow Good Documentation Practices and Data Integrity requirements during any GxP Operation and recording at site. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. To ensure that, in case of any event of potential data breach, it shall be handled through SOP on Handling of Potential Data Integrity Observation. BE / Diploma in Instrumentation Engineering: Responsible for maintenance of water system SCADA , Pretreatment water system , Purified water generation , WFI generation and distribution system , Pure steam generation and distribution system. Maintenance of EMS and BMS system To ensure differential pressures, temperature & Relative Humidity of classified areas within pre-determined limits. Supervise all vendor activities and verify all tests performed by them in clean room validation/variable refrigeration flow air conditioning systems. Authorized to review all documentation of HVAC activities in logbooks, log sheets, AHU filter cleaning records & FMS alarms summary, Qualification Documents of HVAC System. Responsible for AHU qualification / re-qualification & related documentation including in-house & out-sourced testing. Preparation / revision of SOPs for HVAC operations as well as GMP training related to HVAC. To initiate & filled the change control, Deviation & CAPA for HVAC section with coordination of QMS related to Projects. Responsible to Execution of Clean room and HVAC Project with Co-Ordination of Outsourced/Third party. Responsible for Purchase Requisition initiation for consumables. Managing communication with respective Outsourced/Third party vendors and provide support to all project and processes. Provide support to all Breakdown and preventive maintenance requests, Manage all communication and provide efficient feedback for all project activity To Provide Support to engineering department during the period of Plant Audit. To enrol engineering HVAC staff in all trainings in GMP and technical knowhow as and when it is conducted To follow Good Documentation Practices and Data Integrity requirements during any GxP Operation and recording at site. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. To ensure that, in case of any event of potential data breach, it shall be handled through SOP on Handling of Potential Data Integrity Observation.

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland) and London (UK), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department : Late Phase Quality Assurance Designation: Officer/Sr Officer Role: Clinical Data Management Auditor Experience 4-8 years: Education: M.Pharm/B.Pharm Salary: around 8 L Job Description: To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Client s requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for all assigned projects. Performing & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements. To perform retrospective audits of study related raw data like Informed Consent Forms, protocol, project management plan and associated Plan, IMP plan, IMP release checklists, Safety Management Plan (SMP), Clinical Study Report, Medical Imaging documents. Review of SOPs pertaining to Clinical Data Management (CDM) and preparation and review of SOPs pertaining to Quality Assurance. Audit of the clinical database and clinical data management documents (before database lock). Calculation of % Error rate for the clinical database (before database lock) and issue the same to clinical data management. Prepare CDM audit status for incorporation in Audit Certificate/QA statement. Review of Data Management Plan (DMP), Statistical Analysis Plan (SAP-clinical data management aspects) and e-CRF/CRF design of projects in which clinical data management activities are undertaken at/by Lambda Therapeutic Research Ltd Conduct System audit of Clinical Data Management and preparation of audit report. Review of TMF, SMF and Site selection visit report, IMP release checklist. COMPETENCIES Accountability Communication Work Ethic Presentation / Communication skills Organizational Culture fit

Multiple mailboxes handling, fluent in English (written/verbal communications), proactive for communications, Co-ordinating with clients as first contact point for routine communications, support during audits/inspections Basic knowledge of pharmacovigilance Well versed with MS outlook, Powerpoint, Excel. COMPETENCIES Accountability Communication Work Ethic Initiative Presentation / Communication skills Organizational Culture fit Flexibility/Planning & Organizing

Job Description: Reeport Writing Clinical Module Prepration Regualtory Query Responses COMPETENCIES Accountability Communication Work Ethic Motivation/Initiative Presentation / Communication skills Organizational Culture fit

Education: B.SC/M.SC/B.Pharm/M.Pharm Job Description: Multiple mailboxes handling, fluent in English (written/verbal communications), proactive for communications, Co-ordinating with clients as first contact point for routine communications, support during audits/inspections Basic knowledge of pharmacovigilance we'll versed with MS outlook, Powerpoint, Excel. COMPETENCIES Accountability Communication Work Ethic Leadership Presentation / Communication skills Organizational Culture fit

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical- Protiens & Biosimilars Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm or M.Sc. Experience: 0 to 2 years CTC Range: 3 to 4 Lacs Key Responsibilities: Design and execute experiments to assess the PK and immunogenicity of therapeutic compounds using a variety of assays and methodologies. Develop and validate bioanalytical methods for the detection and quantification of anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Collaborate with cross-functional teams to plan and conduct immunogenicity studies, ensuring compliance with regulatory guidelines. Analyze and interpret data, generate scientific reports, and present findings to internal teams and external stakeholders. Stay up-to-date with the latest advancements in immunogenicity bioanalysis and contribute to the development of innovative approaches. Maintain laboratory equipment, ensure data integrity, and adhere to quality control and safety protocols. Participate in regulatory submissions and assist in interactions with sponsor audits as needed. COMPETENCIES Communication Work Ethic Organizational Culture fit Accountability

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Act as Senior Analyst in Bioanalytical Biosimilar Department Department : Bioanalytical- Proteins & Biosimilars Designation: Executive Location : - Ahmedabad Education : M.SC Biotechnology/ Biochemistry Experience: 4-6 yrs. CTC range : 8-10 Lac/annum Job description: Act as a Senior analyst for method validation and studies for LBA PK methods. Candidate has ability to develop and validate of LBA based bioanalytical PK methods and handling of 2 Project/MV activity together with 2-3 analyst team. Analyze serum samples clinical studies as per respective draft/method SOPs. Independent execution of ELISA / ligand binding assays, Collate, analyze and interpret data. Troubleshoot technical challenges during conduct of MD/MV/Projects. Review or prepare Method SOPs, BA-PBS SOPs, Study Plans, Analytical Reports and Validation Reports. Assist in reconciliation of study or MV raw data, Respond to QA and QC communications for in study or in process audits. Management of inventory for critical reagents or study specific general reagents. COMPETENCIES Accountability Communication Work Ethic Organizational Culture fit Initiative

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Late Phase QA Designation: Assistant General Manager Job Location: Ahmedabad (Gujarat) Education: M.Pharm/Ph.D. Experience: 15+ years CTC Range: 20 to 30 Lacs Job Description: Ensure data compilation for Quality Review Board Meeting for Late Phase trials and functions; Data compilation, meeting preparation and discussion, MOM preparation and further followup of action items. Review effectiveness of CAPA management (identification, reporting, impact assessment and CAPA implementation) and Review of various study documents. QA statement and Audit certificate issuance as per applicable regulatory guideline. To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Client s requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for allassigned projects. Conducting & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to current ICH GCP, Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements. Participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.To Support Head- QA/Designee for preparation & review of QA sops and review of system sops of other department (Clinical Trial Management, Medical affairs, medical imaging) for correctness, adequacy and compliance. To provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections. To support Head-QA/Designee for handling regulatory inspections and sponsor system audit, arranging data for regulatory inspection and sponsor system audit, responding to regulatory or sponsor queries pertaining to clinical trial/medical imaging issues, co-ordinate for regulatory/sponsor inspections/audits. To perform retrospective audits of Study protocol and study related raw data, as required. Update Head-QA/Designee regularly on the level of compliance and compliance issues. COMPETENCIES Accountability Work Ethic Initiative Technical Knowledge Organizational Culture fit

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Department: Bioanalytical Operations Designation: Research Associate Job Location: Ahmedabad (Gujarat) Education: M.Pharm/B.Pharm Experience: 5 to 7 years CTC Range: 5 to 7 Lacs Job Description: Ensure project coordination and conduct the study as per protocol and SOPs requirements. Work in close coordination with the Principal Investigator and Study team. Review of study protocol, ICF, CRF and other appendices (applicable in case of Special studies). Handling study related IMPs and its relevant documents (IP retrieval, verification, accountability, dispensing etc.). Communicate with sponsors, other departments and team on appropriate aspects of the clinical studies. Compile and complete raw data in TMF and resolve all QA/QC queries in timely manner. COMPETENCIES Accountability Communication Work Ethic Presentation / Communication skills Organizational Culture fit

Role & responsibilities 1. Act as a Principal Investigator / Co-investigator in phase-1 studies, Biosimilar and BA/BE studies in all therapeutic area as well as various kind of formulation. 2. Feasibility assessment of different molecules as per request from sponsors. 3. Conducted complex BA/BE study at hospital site as Principal Investigator. 4. Involved in Audit/Inspection handling and Projects conducted as Principal Investigator have been audited and cleared by different regulatory. 5. Leading and guiding the Research Staff as Team Lead. 6. Prepare and review protocols for clinical studies 7. Ensure compliance to protocol, SOPs and Regulatory requirements 8. Communicate IEC related issues to all concerned 9. Coordinate with Project Coordinators for all project related matters 10. Monitor and manage adverse events 11. Coordinate with panel of consultants to seek medical opinion as and when required 12. Ensure timely response to QA findings 13. Interact with sponsors on medical related matters 14. Handle safety related issues and ensure appropriate communication 15. Prepare and review reports for clinical studies 16. Overall supervision of screening and check-in activities 17. Write and review related SOPs 18. Contribute towards scientific development of the organization 19. Support clinical trial group 20. Handle medical confidential report and case management 21. Help maintain and update all the systems and SOPs in the department 22. Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs. 23. Any other responsibilities as assigned by the Head of the Department