ORGANISATIONAL OVERVIEW JOB DETAILS Preparation Review of Quotations for BA/BE studies, Late phase clinical trials and pharmacovigilancestudies of the organization Finalization of Quotations in line with final protocols preparation execution of Project SpecificAgreements / Contracts. Preparation and review of Phase I Quotations in consultation with medical team BD. Preparation and review of Quotes for special services like, Nutraceuticals studies, Clinical Lab projects,Biosimilars, complex studies, Standalone CDM, Stats Medical writing services Provide inputs on pricing based on study design complexity to BD Team for Quote Discussion / Pricenegotiation with sponsor. Preparation of Annual Rate Contracts Bid Grids for RFPs in consultation with BD leads. Maintain master database of quotations shared. KEY DELIVERABLES ALLIED RESPONSIBILITIES EXPERIENCE Minimum 2 years of experience in Costing Proposal. EDUCATIONAL QUALIFICATION Bachelor/ Master s in commerce /Graduate / Postgraduate COMPETENCIES Accountability Communication Work Ethic Initiative Leadership Employment History Technical Knowledge Academic Qualifications Motivation/Initiative Interpersonal / Leadership skills Presentation / Communication skills Impression and Enthusiasm Organizational Culture fit Accomplishments Strengths Flexibility/Planning Organizing

ORGANISATIONAL OVERVIEW We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad - India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities.Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly.Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team. JOB DETAILS The candidate should lead DP manufacturing within the Process Sciences group. The role entails utilization of the prospective candidate s vast technical experience to lead a team that will be focused on manufacturing of drug product of clinical grade product quality. KEY DELIVERABLES Drive for results Highest integrity, committed to ethics and scientific standards.Uses an approach to address the task or situation such as delegation, planning, timelines.Perseveres to find ways to work through localized challenges or barriers. Building Effective Teams Empowers team members and encourages them to contribute their skills/ideas.Gets the right talent mix for the task. Shares credit and celebrates wins. Process Management Strong organizational skills, including the ability to prioritize personal and direct reports workload.Abreast with the latest technical innovations and familiarity with Regulatory expectationsSimplifies complex processes.Makes process improvements where value addition is relevant and important.Resourceful, uses resources and people wisely.Be data driven if providing solutions to challenges - also should have the ability to take calculated risks and manage the risks in the most transparent manner.Very good understanding and implementation of the best documentation practices including paper and electronic record keeping.Sufficient industry experience in handling cross functional interactions.Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups. ALLIED RESPONSIBILITIES Strong understanding of DP unit operations like freeze/thaw, filtration, filling, lyophilization, visual inspection, leak detection and packaging. Strong understanding and provide technical leadership for manufacturing aspects for clinical DP including aseptic and compliance aspects in GMP setting. Identify best DP technologies and work with vendors to custom design filling equipment for GMP manufacturing, implementation of critical aseptic compliance aspects like control of bioburden, implementation of PUPSIT. Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects. Support drug product filling line mock up review, functional design review, on site support of FAT and SAT for drug product filling line. Technical leadership for critical validation aspects of DP like media fills, filter validation, hold times, capping. Set up visual inspection program including operator training kits, qualification program. Set up packaging operations for clinical drug product supply. Provide operational expertise and leadership in managing production of clinical material in GMP setting for fill and finish, with deliverance on critical KPIs like right on time, yield and product quality. Technical leadership for troubleshooting of deviations and assess for root cause, implementation of corrective actions and assessment of product quality. Strong understanding of documentation requirements and data integrity applicable for running manufacturing operations. Strong understanding of Annex 1 requirements for aseptic processing. Work with IT and Engineering to ensure that data on manufacturing process parameters, and batch data is accessible and available in formats for data analysis. Must be focused on usage of statistical tools to evaluate process performance and process consistency. Good collaboration skills with clients Responsible for authoring and reviewing technical reports related to drug product, and contribute to regulatory submissions and audits with health agencies. Identify and communicate best practices within the CDMO function. Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development EXPERIENCE Experience in drug product operations (fill and finish) in a GMP setting is required. Experience of leading and managing a team in the bio-pharma industry is very much preferred. Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing, visual inspection and packaging operations. Strong operational expertise in running aseptic operations for drug product manufacturing, and understanding of compliance and implementation aspects around cross contamination, microbiological contamination and facility layout for GMP manufacturing. Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects. Experienced in supporting drug product filling line mock up review, functional design review, on site support of FAT and SAT. Preferred to have knowledge of fill finish of complex biologics like antibodies (monoclonal, bispecifics), recombinant proteins and enzymes. Cross functional technical knowledge is highly desirable. Excellent oral and written communication and interpersonal skills will be desired. EDUCATIONAL QUALIFICATION Masters or Ph.D in Chemical/Biochemical Engineering or similar disciplines with 12+ years of work experience in drug product development and manufacturing or B.Tech/B.E in Chemical/Biochemical engineering or similar disciplines with 14+ years of work experience in drug product development and manufacturing. COMPETENCIES Accountability Communication Work Ethic Initiative Leadership Flexibility/Planning Organizing Organizational Culture fit Motivation/Initiative Impression and Enthusiasm Presentation / Communication skills Interpersonal / Leadership skills Technical Knowledge Accomplishments Strengths

ORGANISATIONAL OVERVIEW Lambda Therapeutic Research stands at the forefront of the global Clinical Research Organization (CRO) landscape, with its headquarters in Ahmedabad, India, and a presence extending across Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), London (UK), and Warsaw (Poland).Our unwavering mission revolves around providing comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Lambda consistently sets new standards in the Clinical Research sector, achieving milestones through both organic growth and strategic acquisitions. In 2019, we strategically expanded our North American presence by acquiring Novum Pharmaceutical Research Services, a distinguished 50-year-old CRO. This strategic move, following the integration of Biovail s RD facilities in Canada in 2010, marked Lambda s second significant acquisition in North America. It is a key player in the CRO industry.Lambda Therapeutic Research has earned widespread recognition for its dedication to excellence, including being named the Best Indian CRO by Frost Sullivan (USA) and receiving the esteemed title of Great Indian Workplace by UBS Transformance. Recently, Lambda proudly received the Regulatory Excellence Award at the CPhI Awards 2023 and the Industry Partner of the Year Award at the Global Generics Biosimilar Awards 2023 . Lambda has also been acknowledged by Industry Outlook as one of the Top 10 CROs ( Contract Research Organizations ) 2023 . These accolades underscore our unwavering commitment to regulatory compliance, industry leadership, and impactful collaborations within the biotech, pharmaceutical and clinical research sectors. JOB DETAILS Work as principal investigator KEY DELIVERABLES ALLIED RESPONSIBILITIES EXPERIENCE 5 years of progressively responsible experience in clinical research in an academically based research institute, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required. EDUCATIONAL QUALIFICATION MBBS COMPETENCIES Accountability Communication Work Ethic Initiative Leadership Employment History Technical Knowledge Academic Qualifications Motivation/Initiative Interpersonal / Leadership skills Presentation / Communication skills Impression and Enthusiasm Organizational Culture fit Accomplishments Strengths Flexibility/Planning Organizing

Role & responsibilities 1. 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 Clients requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for all assigned projects2. 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 requirements3. Support Head-QA/Designee for handling regulatory inspections, Sponsor system audit, arranging data for regulatory inspection, Sponsor system audit4. Provide Audit and inspection support for assigned projects including where feasible, advising the project team during preparation and conduct of external audits and inspection5. 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 related documents6. Prepare and review of QA SOPs, review of system SOPs (CTM, MI, CTM-MS) and working instructions of other department (Clinical Trial Management) for correctness, adequacy and compliance7. After completion of all the stages of audit for undertaken clinical trial, prepare the risk analysis of observations and suggest mitigation plan to concerned department and to share the report with management8. To review and provide inputs to sponsor query responses and facilitate regulatory inspections at site in conjunction with operation team (as applicable)9. Planning and communications for On-site audit for all applicable projects, vendor audit Management10. Compilation of the data and updation of internal tracker/database at regular interval to perform trend analysis11. Audits of Trial Master File, Site Master File, Protocol deviation tracker and SAE tracker at various stages of the clinical trial12. Process Owner of Training Management System13. Update Head-QA/Designee regularly on the level of compliance and compliance issues14. Any other responsibilities as assigned by the Management/HOD15. To assist in completion of assigned system audits16. Audit of the clinical database and clinical data management documents (before database lock)17. 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 statement18. Review of Data Management Plan (DMP), Statical Analysis Plan (SAP CDM aspects) and eCRF/CRF design of projects in which clinical data management activities are undertaken at/by Lambda Therapeutics Research Ltd19. Conduct System audit of Clinical Data Management and preparation of audit reportPreferred candidate profile - Candidate should have minimum 4 yrs. experience in Clinical Research Organisation.

Role & responsibilities The candidate should lead DP manufacturing within the Process Sciences group. The role entails utilization of the prospective candidates vast technical experience to lead a team that will be focused on manufacturing of drug product of clinical grade product quality. Specific Job Responsibilities: Strong understanding of DP unit operations like freeze/thaw, filtration, filling, lyophilization, visual inspection, leak detection and packaging.Strong understanding and provide technical leadership for manufacturing aspects for clinical DP including aseptic and compliance aspects in GMP setting.Identify best DP technologies and work with vendors to custom design filling equipment for GMP manufacturing, implementation of critical aseptic compliance aspects like control of bioburden, implementation of PUPSIT.Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects.Support drug product filling line mock up review, functional design review, on site support of FAT and SAT for drug product filling line.Technical leadership for critical validation aspects of DP like media fills, filter validation, hold times, capping.Set up visual inspection program including operator training kits, qualification program.Set up packaging operations for clinical drug product supply.Provide operational expertise and leadership in managing production of clinical material in GMP setting for fill and finish, with deliverance on critical KPIs like right on time, yield and product quality.Technical leadership for troubleshooting of deviations and assess for root cause, implementation of corrective actions and assessment of product quality.Strong understanding of documentation requirements and data integrity applicable for running manufacturing operations. Strong understanding of Annex 1 requirements for aseptic processing.Work with IT and Engineering to ensure that data on manufacturing process parameters, and batch data is accessible and available in formats for data analysis.Must be focused on usage of statistical tools to evaluate process performance and process consistency.Good collaboration skills with clients Responsible for authoring and reviewing technical reports related to drug product, and contribute to regulatory submissions and audits with health agencies.Identify and communicate best practices within the CDMO function.Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development Core Competencies Drive for resultsHighest integrity, committed to ethics and scientific standards.Uses an approach to address the task or situation such as delegation, planning, timelines. Perseveres to find ways to work through localized challenges or barriers. Building Effective TeamsEmpowers team members and encourages them to contribute their skills/ideas. Gets the right talent mix for the task. Shares credit and celebrates wins.Process ManagementStrong organizational skills, including the ability to prioritize personal and direct reports’ workload.Abreast with the latest technical innovations and familiarity with Regulatory expectationsSimplifies complex processes.Makes process improvements where value addition is relevant and important.Resourceful, uses resources and people wisely.Be data driven if providing solutions to challenges – also should have the ability to take calculated risks and manage the risks in the most transparent manner.Very good understanding and implementation of the best documentation practices including paper and electronic record keeping.Sufficient industry experience in handling cross functional interactions.Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups. Relevant Functional/Technical Skills or Industry Experience Experience in drug product operations (fill and finish) in a GMP setting is required.Experience of leading and managing a team in the bio-pharma industry is very much preferred.Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing, visual inspection and packaging operations.Strong operational expertise in running aseptic operations for drug product manufacturing, and understanding of compliance and implementation aspects around cross contamination, microbiological contamination and facility layout for GMP manufacturing.Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects.Experienced in supporting drug product filling line mock up review, functional design review, on site support of FAT and SAT.Preferred to have knowledge of fill finish of complex biologics like antibodies (monoclonal, bispecifics), recombinant proteins and enzymes.Cross functional technical knowledge is highly desirable.Excellent oral and written communication and interpersonal skills will be desired. Relevant Professional / Educational Background: Masters or Ph.D in Chemical/Biochemical Engineering or similar disciplines with 12+ years of work experience in drug product development and manufacturing or B.Tech/B.E in Chemical/Biochemical engineering or similar disciplines with 14+ years of work experience in drug product development and manufacturing.

The candidate should establish Process automation functionality for Development labs and cGMP facility for Lambda CDMO. The role entails utilization of the prospective candidates vast technical experience to execute and run a team that will be focused on day-to-day work of Process automation and its integration in compliance environment. Candidate should be subject matter expert in implementation of digital platforms (e.g. MFCS, Unicorn, ELN, LIMS, Empower, Chromeleon, CDS, AVEVA Pi and eLog Book) Specific Job Responsibilities: Plant Automation Systems Management: Maintain and optimize plant automation systems, including SCADA, PLC and IPC systems with L2 integration. To organize for and maintain the latest software for PLCs, HMIs and SCADA in plant and QC.Troubleshooting and Resolution: Troubleshot and resolve issues promptly to minimize downtime and ensure operational efficiency for critical biopharmaceutical equipment like bioreactors, chromatography systems, robotic filling lines, QC and analytical equipments. Automation Recipe Development: Create and validate process automation recipes for biopharma equipments like Bioreactors, Chromatography, TFF systems, HPLC systems, liquid handling unitsL1-L4 Integration: Drive the automation aspects of integration across L1 (data from instruments/equipment), L2 (e.,g SCADA/PLC), L3 (e.,g EBR), L4 (e.,g Historian)Functional Specification: Review of functional specification documents from instrument / equipment vendors for automation aspects.6. Active Involvement in MES Project Activities: Play a key role as a core team member in overseeing and driving MES (Manufacturing Execution System) project activities along with users and IT.Manage and supervise tasks related to L2 Integration activities to support MES utilization.Develop and executed project plans for MES implementation and automation system.Assist in preparing and reviewing Standard Operating Procedures (SOPs) and work instructions related to the MES project.Serve as the SME for selecting technical specifications of MES infrastructure package materials, including MES software licenses and various hardware components such as tablets, printers, barcode scanners.7. Project Coordination: Coordinate with the team according to project schedules to monitor, track and ensure progress.8. Cross-functional Collaboration: Collaborate with cross-functional teams, including end-users, IT, operations, and quality assurance to facilitate the seamless integration of MES with ERP, weigh scale, and L2 systems.9. Efficient Management of Project Material Procurement and Installation: Manage the procurement and installation of project materials, ensuring timely delivery and adherence to project timelines.10. Compliance with Health, Safety, Environment, and Energy Policies: Ensured adherence to Environment, Health and Safety policies to maintain a safe and compliant workplace Provide support during regulatory inspections.11. Adherence to Good Documentation Practices and Data Integrity: Ensured compliance with Good Documentation Practices (GDP) and Data Integrity requirements during all GxP operations and documentation at the site.12. Data Breach Management: Ensured that any potential data breach is addressed in accordance with the SOP for Handling of Potential Data Integrity Observations Core Competencies Should be a bio-pharma industry expert in process and analytical automation.Strong organizational skills, including the ability to prioritize personal and direct reports workload.Abreast with the latest technical innovations and familiarity with Regulatory expectationsAnalyzing automation problems and providing inputs for change.Very good understanding and implementation of the automation across CDMO functions and electronic record keeping.Sufficient industry experience in handling cross functional interactions.Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups. Relevant Functional/Technical Skills or Industry Experience Responsible for preparation and review of documentation related to qualifications of LIMS, ELN and any other digital platforms.Responsible for automation related troubleshooting.Knowledge of systems like Siemens, X works, Delta V DCSKnowledge of Java, C++, Python advantageous.Experience working with control panels and PLC control systemsExperience in troubleshooting and set up support for automation for biopharmaceutical equipment like bioreactors, robotic filling equipment, chromatography systems.Strong knowledge of industry-specific regulations and standards.Ensuring the quality and suitability of systems installed in the CDMO facility for maintaining integrity and safety.Technical competence in appropriate scientific discipline or technology will be of great value.Strong Cross functional communication skills is highly desirable.Excellent oral and written communication and interpersonal skills will be desired. Relevant Professional / Educational Background: BTech/MTech/BE in Electrical Engineering / Computer Engineering/Information Technology / Control Systems Engineering / related Branch of Engineering with 8 to 12 years of relevant work experience in Process and analytical Automation and digitization for biopharma/biotech or relevant contract research labs.The preference will be for personnel who have prior experience in Process and analytical Automation and its compliance.Work experience on digital compliance in the bio-therapeutic industry will be an added advantage.