341 Technology Transfer Jobs - Page 11

Overview Solves highly complex business issues and problems with automated systems. Technology Requirements: Strong expertise in Siebel Configuration, Siebel Tools, Siebel Workflow, and Siebel Scripting. Proficient in installing and deploying enterprise-scale Oracle Siebel CRM environments, including Siebel Tools and Developer Web Client setup and configuration. Knowledge of Oracle Siebel Architecture, Administration, and integration, including automated builds, deployment manager, repository import/export, table activation, and object manager maintenance. Responsibilities Manages the development of software-as-a-service (SaaS) and enterprisewide applications associated with the collection, retrieval, accessibility and usage of data for internal department planning and activities Manages mission critical process flows and solutions for business problems Performs complex configuration, setup, and updating of application, including table definitions and access control Manages validity of complex data entered into established tables, fields and system databases Designs extensions and tailored solutions required for aligning packaged applications for business scenarios Builds and produces complex reports using query and flexible reporting tools to meet the requirements of business management and staff Manages set up and user accesses Implements changes in applications development, maintenance and system standards. Provides timely resolution of problems or escalation on behalf of customer Manages complex system upgrades including planning and scheduling, coordination and deploying Manages availability and performance of systems and application environments through proactive as well as reactive analysis and maintenance Leads cross-functional linked teams to address business or systems issues Qualifications Bachelor's Degree required. Advanced Degree preferred 7-10 years of experience in to Siebel CRM Experience into Open UI Development is Mandatory. Strong communication skills to effectively work with others Demonstrated ability to solve end user issues Advanced technical experience Ability to mentor team members Managing complex issues and applying root cause analysis Expert knowledge of applicable IT systems/applications Ability to implement new systems and tools Experience managing IT documentation processes Advanced analytical skills Advanced demonstration of project managing IT solutions Manages in a fast-paced, high growth, rapidly changing environment Demonstrated ability to identify and implement process improvements

Must to have experience on new product development, technology transfer, and process validation from R&D to pilot scale and further to commercial production. Develop BFD, PFDs, and P&IDs for new products and process trials.

To lead & support process development, scale-up, troubleshooting & optimization of chemical processes from laboratory to commercial plant scale, ensuring safety, cost-efficiency, and robust performance, Documentation & Compliance. Required Candidate profile BE/B.Tech/M.Tech - Chemical Engg. Full Time with 3+ years of experience specialty/fine Agro, pharma intermediates Knowledge of pilot plant setup, GLRs, SS reactors, reboilers, distillation columns, Perks and benefits GTLI/GPA/GMC/Transportation/Canteen

Role & responsibilities Responsible for technology transfer activities from lab scale to commercial scale. Maintain individual training records. Prepare and approve P&ID and PFDs. Prepare PFDs, mass balance and perform HAZOP study. Prepare trial reports. Draft, review, and approve TMPR and MPR documents. Design and review of critical equipments & approve GA drawing. Calculate Utility and effluent load. Co-ordinate for design, installation, and qualification activities. Maintain environment, health & safety parameters within company premises. Prepare controlling budgets for OPEX (material, consumables etc.) and contribute to CAPEX planning. Prepare, review, and approve the documents relevant to process development lab. Execution of SAP related activities. Act as a Functional Administrator (FA) for managing training activities for respective department in LMS. Perform daily operations in process development lab. Preferred candidate profile Proven experience in Technology Absorption & Validation department within a reputed API pharma organization. Hands-on expertise in the execution of validation activities for process control system. In-depth knowledge in execution of validation and scale up batches for all the products to be manufactured at site. Sound knowledge of SAP and BOM Creation. Proficiency in drafting and reviewing of SOP’s, HAZOP, TTR, etc. Excellent Communication and problem-solving skills. Should be assertive, proactive, and self-driven. Ability to work in adynamic environment.

Responsible for Technology Transfer related activities for a large chemical manufacturing unit in Bharuch. Required Candidate profile BE - Chemical from a reputed institute with 10+ yrs experience in same field.

About The Role : Role Purpose The purpose of this role is to provide solutions and bridge the gap between technology and business know-how to deliver any client solution Do 1. Bridging the gap between project and support teams through techno-functional expertise For a new business implementation project, drive the end to end process from business requirement management to integration & configuration and production deployment Check the feasibility of the new change requirements and provide optimal solution to the client with clear timelines Provide techno-functional solution support for all the new business implementations while building the entire system from the scratch Support the solutioning team from architectural design, coding, testing and implementation Understand the functional design as well as technical design and architecture to be implemented on the ERP system Customize, extend, modify, localize or integrate to the existing product by virtue of coding, testing & production Implement the business processes, requirements and the underlying ERP technology to translate them into ERP solutions Write code as per the developmental standards to decide upon the implementation methodology Provide product support and maintenance to the clients for a specific ERP solution and resolve the day to day queries/ technical problems which may arise Create and deploy automation tools/ solutions to ensure process optimization and increase in efficiency Sink between technical and functional requirements of the project and provide solutioning/ advise to the client or internal teams accordingly Support on-site manager with the necessary details wrt any change and off-site support 2. Skill upgradation and competency building Clear wipro exams and internal certifications from time to time to upgrade the skills Attend trainings, seminars to sharpen the knowledge in functional/ technical domain Write papers, articles, case studies and publish them on the intranet Deliver No. Performance Parameter Measure 1. Contribution to customer projects Quality, SLA, ETA, no. of tickets resolved, problem solved, # of change requests implemented, zero customer escalation, CSAT 2. Automation Process optimization, reduction in process/ steps, reduction in no. of tickets raised 3. Skill upgradation # of trainings & certifications completed, # of papers, articles written in a quarter

To be responsible for planning and execution of scale up, pilot plant operations & supervise smooth transfer from R &D to pilot plant till commercialization To ensure online documentation To ensure continuity of operations in subsequent shifts Required Candidate profile Must have experience of process development, scale up and technology transfer of formulations of different dosage.

Company Name : Oneiro Lifecare Pvt Ltd (Pharma API Company) Designation: Group Leader R & D Location – Ekalbara -Vadodara Role & responsibilities : 1. Literature search, route scouting and ROS finalization. 2. Prepare the cost estimation sheet after literature, feasibility and lab validation. 3. Indent the raw materials. 4. Design experiment for feasibility and optimization. 5. Synthesis of impurity standards and reference standards for intermediates, finished product and its characterization. 6. Prepare scientific documents like SER & TTD and share to QA. 7. Transfer the technology of API/intermediates to production department and provide the support during execution. 8. Support to production team for trouble shooting. 9. Identify cost improvement area in existing product. 10. Check lab note book and provide guidance if any. 11. Support to cross function team to resolve customer query. 12. Motivates, develop and train research staff to achieve goals. 13. To support in failure of investigation for OOS, OOT, Deviation and other failure. 14. To review and approval of standard operating procedure. 15. To review impact assessment to change control. 16. To support for new alternate vendor for key starting materials. 17. To support the manufacturing department if any troubleshooting occurs. 18. Responsible for other activities as instructed by Head R&D/ COO Technical whenever required. if interested and ready to relocate, contact on this email ID: corporate.hr@exemedpharma.com

End-to-end Tecnology Transfer activities Master document review related to tech transfer. Review QMS and artwork. Coordination with cross functioning team on project progress. Visit or review the project manufacturing site for project overview.

Work Experience (Total number of years/ experience/ background or equivalent) : Total experience (in years): 15 Experience in current role (in years): 6.5 Years Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management Primary Job Function - To drive technology transfer for Third party manufacturing, Loan license projects, Abbott s own manufacturing plants. To support Abbott site MS&T team as per requirements. To support Alternate supplier qualification of raw materials & API. To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements. Core Job Responsibilities - To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer. To prepare Master formula record & Technology transfer protocol for products identified for transfer. To Review receiving site s draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation. To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches. To review executed process validation batch documents & support FLQR approvals. To service, trouble shoot and solve production process problems at manufacturing site. To acquire sufficient process understanding at current manufacturing site to enable effective investigations of commercial batch failure or market complaints and to contribute towards appropriate CAPA. To carry out due diligence of new sites with focus on formulation and required infrastructure and support new product acquisitions & product certifications. To work towards improving knowledge base for handling of Parenteral products in addition to the other dosage forms such as Oral solids, Oral liquids, Topicals, etc. To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification and Material Harmonization. To initiate, review & approve change controls in Soltraq. To author, review & approve technical documents in Darius. To extend support to NPI activities like Dossier review, Product certification & FLQR approval. To extend support to I&D for new product launches, review & approval of technical documents, batch monitoring & FLQR approval. To keep track of ongoing projects and update senior management beforehand.

Role & responsibilities 1. Formulation & Development for emerging & regulated market. 2. Execution of Lab Trial batches & Tech Transfer activities at site. 3. Lab note book writing & documentation ensuring compliance with regulatory guidelines \ Preferred candidate profile - Experience in Tablets, Capsule, Pellets, ER, SR, and DR product development for emerging market.

Job Title: Management Associate MPD – AMA Contract Resource Department: MPD-BB, AMA PHC Location: Andheri East Chakala, Mumbai Position Type: Full-Time, Contractual Vacancies: 1 Job Description: We are seeking a Management Associate to support the MPD – AMA team on a contractual basis. This role involves key responsibilities in pharmaceutical documentation, data management, and coordination to ensure efficient support to formulation and analytical development teams. Key Responsibilities: Setup of Enovia DSM for formulation parts and documentation. Compilation and tracking of stability study data for review and approval in Enovia. Raise and manage Change Controls in Veeva QA system for MPD department (CCPs in scope). Maintain status trackers for ongoing/pending CCPs and ensure timely closure and action item follow-ups. Support the MPD Process and Analytical teams with preparation of batch records and other regulatory documentation. Create Coupa Purchase Orders (POs) based on verified quotations. Perform QC Soft entries for reports on stability data, raw material samples, and protocol documentation. Coordinate with the MPD lab team for: Disposal of laboratory waste. Dispatching samples for external testing with accurate documentation. Updating records for destruction of leftover stability samples. Assist in TT document and supplier qualification reviews . Liaise with RM suppliers for collection and review of material qualification and safety documents . Perform additional tasks as assigned by the MPD team. Qualifications: B. Pharm / M. Pharm from a recognized institution. Experience: Minimum 2 years of relevant experience in Formulation Development (F&D) and Technology Transfer functions in a reputed pharmaceutical company. Key Skills: Familiarity with Veeva QA, Enovia DSM, QC Soft, and Coupa Strong knowledge of pharmaceutical documentation and stability study processes Experience in Change Control and Regulatory Compliance Good communication and coordination skills Proficient with MS Teams, SharePoint, and Email correspondence

Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information

Role & responsibilities 1. Literature Search, Pharmacopoeia and Patent Search, Review and Discussion and Documentation. 2. Application of NOC, Test License, Manufacturing and Import License 3. Reference product Characterization, Manufacturing and Import License. 4. Reference product Characterization, Reverse Engineering and prototype development. 5. Preformulation study, Manufacturing of bench scale trials for formulation development. 6. Manufacturing of process optimization batches, scale up batches and submission batches. 7. Preparation of Bill of Material, Master Formula Record for manufacturing of submission batches. 8. Preparation of Product development Report for regulatory filing of products. 9. Should have knowledge on product development requirements for Regulated market (EU/UK/Canada). 10. Should have knowledge on QbD and DOE, formulation development and Process development of drug products. 11. Coordination with CFTs like: DQA, Clinicals, Regulatory, Technology transfer and production for smooth development and transfer of product from laboratory to Production floor. 12. Knowledge on IR/MR solid oral drug products. Preferred candidate profile Male candidate only

Who We Are Applied Materials is the global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that helps our customers manufacture display and semiconductor chips- the brains of devices we use every day. As the foundation of the global electronics industry, Applied enables the exciting technologies that literally connect our world- like AI and IoT. If you want to work beyond the cutting-edge, continuously pushing the boundaries of"science and engineering to make possible"the next generations of technology, join us to Make Possible® a Better Future. What We Offer Location: Bangalore,IND At Applied, we prioritize the well-being of you and your family and encourage you to bring your best self to work. Your happiness, health, and resiliency are at the core of our benefits and wellness programs. Our robust total rewards package makes it easier to take care of your whole self and your whole family. Were committed to providing programs and support that encourage personal and professional growth and care for you at work, at home, or wherever you may go. Learn more about our benefits . Youll also benefit from a supportive work culture that encourages you to learn, develop and grow your career as you take on challenges and drive innovative solutions for our customers."We empower our team to push the boundaries of what is possible"”while learning every day in a supportive leading global company. Visit our Careers website to learn more about careers at Applied. Key Responsibilities Working knowledge of NPME role. Under guidance of management, develops, implements, and releases new product BOMs for medium complex assemblies and product structure. Works with senior NPME to implement new product manufacturing, test, and sourcing strategies. Develops and validates Operation Method Sheets (OMS) for medium complex assemblies. Partners with Sr NPMEs in 3D solid model virtual analysis process, including Master Layout (MLO) and Digital Mock Up (DMU). Participates in design reviews, providing DFA, DFAe, DFTp, ITO, and operational efficiency improvement feedback to new product development team to drive cost, quality, and cycle time goals. Partners with Sr NPME to log change requests and executes change control processes including Non Standard Requests (NSRs), Engineering Change Orders (ECOs), Change Control Board (CCB), Supplier Problem Sheets (SPSs), Engineering Specification Waivers (ESWs). Documents product-related issues/enhancement opportunities. Assists in determining root cause analysis.. Leads the Managed Build process for assemblies/modules. Provides technical support and training to Applied and contract manufacturing resources, including piece part suppliers related to assemblies/modules. May perform other duties as assigned. Other : This position may require standing for extended periods of time, walking, working in tight spaces, bending, squatting, twisting, kneeling, reaching, lifting, the ability to distinguish between colors, the ability to work in an environment with noise that may be difficult for some individuals with sensitivity to noise, and the use of hand and power tools. Additionally, because this position also may involve working in a clean room, the use of appropriate Personal Protective Equipment such as coveralls, hoods, booties, safety glasses, gloves, respirators, chemical aprons, and face shields may be required. Functional Knowledge Demonstrates expanded conceptual knowledge in own discipline and broadens capabilities Business Expertise Understands key business drivers; uses this understanding to accomplish own work Leadership No supervisory responsibilities but provides informal guidance to new team members Problem Solving Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents Impact Impacts quality of own work and the work of others on the team; works within guidelines and policies Interpersonal Skills Explains complex information to others in straightforward situations Additional Information Time Type: Full time Employee Type: Assignee / Regular Travel: Relocation Eligible: No Applied Materials is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law.

Who We Are Applied Materials is the global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that helps our customers manufacture display and semiconductor chips- the brains of devices we use every day. As the foundation of the global electronics industry, Applied enables the exciting technologies that literally connect our world- like AI and IoT. If you want to work beyond the cutting-edge, continuously pushing the boundaries of"science and engineering to make possible"the next generations of technology, join us to Make Possible® a Better Future. What We Offer Location: Bangalore,IND At Applied, we prioritize the well-being of you and your family and encourage you to bring your best self to work. Your happiness, health, and resiliency are at the core of our benefits and wellness programs. Our robust total rewards package makes it easier to take care of your whole self and your whole family. Were committed to providing programs and support that encourage personal and professional growth and care for you at work, at home, or wherever you may go. Learn more about our benefits . Youll also benefit from a supportive work culture that encourages you to learn, develop and grow your career as you take on challenges and drive innovative solutions for our customers."We empower our team to push the boundaries of what is possible"”while learning every day in a supportive leading global company. Visit our Careers website to learn more about careers at Applied. Key Responsibilities 1.With management supervision, develops, implements, and releases new product BOMs for moderately complex assemblies and product structure. Works with senior NPME to implement new product manufacturing, test, and sourcing strategies. 2.Develops and validates Operation Method Sheets (OMS) for moderately complex assemblies. 3.Partners with Sr NPMEs in 3D solid model virtual analysis process, including Master Layout (MLO) and Digital Mock Up (DMU). Participates in design reviews, providing DFA, DFAe, DFTp, ITO, and operational efficiency improvement feedback to new product development team to drive cost, quality, and cycle time goals. 4.Partners with Sr NPME to log change requests and executes change control processes including Non Standard Requests (NSRs), Engineering Change Orders (ECOs), Change Control Board (CCB), Supplier Problem Sheets (SPSs), Engineering Specification Waivers (ESWs). 5.Documents product-related issues/enhancement opportunities. Assists in determining root cause analysis.. 6.Leads the Managed Build process for assemblies/modules. 7.Provides technical support and training to Applied and contract manufacturing resources, including piece part suppliers related to assemblies/modules. 8.May perform other duties as assigned. Other : This position may require standing for extended periods of time, walking, working in tight spaces, bending, squatting, twisting, kneeling, reaching, lifting, the ability to distinguish between colors, the ability to work in an environment with noise that may be difficult for some individuals with sensitivity to noise, and the use of hand and power tools. Additionally, because this position also may involve working in a clean room, the use of appropriate Personal Protective Equipment such as coveralls, hoods, booties, safety glasses, gloves, respirators, chemical aprons, and face shields may be required. Functional Knowledge Demonstrates expanded conceptual knowledge in own discipline and broadens capabilities Business Expertise Understands key business drivers; uses this understanding to accomplish own work Leadership No supervisory responsibilities but provides informal guidance to new team members Problem Solving Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents Impact Impacts quality of own work and the work of others on the team; works within guidelines and policies Interpersonal Skills Explains complex information to others in straightforward situations Additional Information Time Type: Full time Employee Type: Assignee / Regular Travel: Not Specified Relocation Eligible: Yes Applied Materials is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law.

Job Description: 1.Candidate must have knowledge Product Development, Characterization, Literature Search, Prototype Development, Scale-up Batches, Exhibit Batches, DOE Experiments , PDR Preparation & Development related documentation. Experience in US ,EU Markets .Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D.Role & responsibilities Position : Executive/Sr Executive/Asst Manager Experience : 3 12 Yrs. Qualification: M. Pharm -Pharmaceutics Total Exp: Current CTC: Exp CTC : Notice Period: Current Designation:

Dear Respected All, Greeting from Biophore India pharmaceutical Pvt Ltd. We have opening for Formulation R&D Department - oral solution exp or Injectable Experience : 2-10 Yrs Job Location: Pashamylaram - Patancheruv Job Description: Candidate must have knowledge-Literature Search, Product Development,Scale-up Batches, Characterization, Prototype Development, , Exhibit Batches, DOE Experiments , PDR Preparation & Development related documentation. Experience in US ,EU Markets .Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. Ref to Friends or colleagues Please share me update resume: careers@biophore.com Total Exp : Current C T C : Exp C T C : Notice Period: Current Designation:

Roles and Responsibilities Develop process designs, including P&IDs, flowsheets, and equipment sizing. Conduct process simulations using Aspen Hysys, Aspen Plus, or other relevant software tools. Collaborate with cross-functional teams to optimize processes for energy efficiency and cost reduction. Perform debottlenecking studies to improve plant capacity utilization and reduce bottlenecks. Participate in scale-up activities from lab to commercial production. Preparation of Process flow (PFD) & P&ID Monitoring the Process validation batches as per cGMP Experience on Solvent recovery and re use Experience on Process time cycle reduction Equipment mapping and suitability as per the process Material and energy balance calculation Desired Candidate Profile B.Tech/B.E. degree in Chemical Engineering (or equivalent). 1-5 years of experience in chemical processing engineering with expertise in technology transfer, process validation, and scale up. Strong understanding of chemical engineering principles and practices; knowledge of thermodynamics, kinetics, mass transport phenomena etc.

Dear Respected All, Greeting from Biophore India pharmaceutical Pvt Ltd. We have opening for Formulation R&D Department - oral solution exp or Injectable Experience : 2-7 Yrs Job Location: Pashamylaram - Patancheruv-Sangareddy Dist. Job Description: Candidate must have knowledge-Literature Search, Product Development,Scale-up Batches, Characterization, Prototype Development, , Exhibit Batches, DOE Experiments , PDR Preparation & Development related documentation. Experience in US ,EU Markets .Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. Ref to Friends or colleagues Please share me update resume: careers@biophore.com Total Exp : Current C T C : Exp C T C : Notice Period: Current Designation:

Applications are invited for the Post of Junior Research Fellow (JRF) for the ANRF-SERB funded Core Research Grant (CRG)Projectin theSchool of Chemical Engineering (SCHEME),atVellore Institute of Technology (VIT), Vellore (Sanction order dated 01 August 2024) Title of the Project Design and Characterization of Novel Hydrodynamic Cavitation Reactor for Wastewater Treatment Qualification M. Tech / M.E in Chemical/Environmental Engineering, or a related engineering field with one or two years of experience in water and wastewater treatment is desirable. Describe if any Candidates having knowledge inconducting lab/pilot scale experiments in wastewater treatment will be given preference.

Applications are invited for the Post of Junior Research Fellow (JRF) for the ANRF-SERB funded Core Research Grant (CRG)Projectin theSchool of Chemical Engineering (SCHEME),atVellore Institute of Technology (VIT), Vellore (Sanction order dated 01 August 2024) Title of the Project Design and Characterization of Novel Hydrodynamic Cavitation Reactor for Wastewater Treatment Qualification M. Tech / M.E in Chemical/Environmental Engineering, or a related engineering field with one or two years of experience in water and wastewater treatment is desirable. Describe if any Candidates having knowledge inconducting lab/pilot scale experiments in wastewater treatment will be given preference.

Role & responsibilities Job Title: MSAT - Technology Transfer Specialist (Injectables) Job Summary: The MSAT Technology Transfer Specialist for Injectables will be responsible for overseeing the transfer of injectable drug products from development to commercial manufacturing. This role requires close collaboration with cross-functional teams, including R&D, Quality, Manufacturing, and Engineering, to ensure a seamless transfer process, operational excellence, and compliance with cGMP regulations. Key Responsibilities: Technology Transfer Oversight: Lead and coordinate the transfer of injectable drug products from development to commercial production facilities. Ensure that all documentation, including protocols, procedures, and specifications, is complete and accurate during the transfer process. Collaborate with R&D and other departments to troubleshoot and resolve technical issues during the technology transfer. Cross-Functional Collaboration: Work closely with internal teams (Manufacturing, Engineering, Quality, and Regulatory Affairs) to ensure alignment and understanding of technical requirements during the transfer. Serve as a point of contact between the development team and the commercial manufacturing site, facilitating communication and ensuring a smooth transition. Process Development and Optimization: Provide technical expertise to optimize manufacturing processes for injectables. Identify and implement process improvements to enhance product yield, quality, and cost-effectiveness. Ensure that manufacturing processes are scalable, robust, and compliant with regulatory standards. Regulatory Compliance: Ensure that all aspects of the technology transfer process adhere to cGMP (current Good Manufacturing Practices) and regulatory requirements. Support regulatory submissions by providing necessary documentation and technical information as needed. Training and Knowledge Transfer: Develop and conduct training sessions for production personnel, ensuring that they are well-prepared for the commercial production of the injectable products. Transfer critical knowledge related to formulation, filling, and packaging processes to manufacturing teams. Process Validation: Lead and support process validation activities, ensuring that processes are qualified and validated in accordance with regulatory requirements. Oversee the creation, review, and approval of process validation protocols and reports. Problem Solving and Troubleshooting: Troubleshoot and resolve any issues that arise during the technology transfer and manufacturing processes. Apply scientific and technical knowledge to identify root causes and implement corrective and preventive actions. Continuous Improvement: Lead or support continuous improvement initiatives to enhance the efficiency, quality, and consistency of the injectable manufacturing processes. Support initiatives to reduce cycle times, improve yield, and minimize waste. Documentation and Reporting: Prepare and review required technical documentation, including batch records, validation protocols, and reports. Ensure timely and accurate reporting of technology transfer progress, challenges, and resolutions to senior management. Project Management: Manage the technology transfer timeline, ensuring all milestones are met within established deadlines. Monitor the progress of technology transfer activities, identify potential risks, and implement mitigation strategies to ensure successful completion. Qualifications: Education : Bachelors or master’s degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field. Experience : 5+ years of experience in technology transfer, manufacturing, or process development within the pharmaceutical industry, with a focus on injectables. Strong knowledge of cGMP and regulatory requirements for injectable drug products. Proven experience in process optimization, troubleshooting, and scaling up manufacturing processes. Experience with project management and cross-functional team collaboration. Skills: Strong technical understanding of injectable drug products, including formulation, filling, and packaging processes. Excellent communication, teamwork, and leadership skills. Proficient in technical documentation and report writing. Familiarity with Lean, Six Sigma, or other process improvement methodologies is a plus. Preferred candidate profile

Knowledge of ich guidelines and different global regulatory authorities requirements related to products and its methods, control strategy towards critical quality attributes. Understand customer expectations on to-be manufactured product.

Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.