332 Technology Transfer Jobs - Page 2

Role & responsibilities Manage technology transfer activities from development to commercial manufacturing for OSD tablets. Oversee and execute process scale-up, process optimization, and validation to ensure smooth transition into commercial production. Maintain an in-depth knowledge of USFDA regulations for OSD products and ensure compliance with all regulatory requirements during tech transfer activities. Work closely with R&D, manufacturing, and quality teams to address any technical challenges during tech transfer. Preferred candidate profile Prefered candidates from OSD (manufacture Tablets , capsules,)background . USFDA experince is must Its a plant based role.

We are looking for a highly skilled and experienced Test Pilot (UAV) to join our team at Marvel Geospatial Solutions Pvt Ltd. The ideal candidate will have 7-8 years of experience in the IT Services & Consulting industry, with expertise in UAV technology. Roles and Responsibility Develop and implement test plans for UAV systems to ensure they meet required standards. Conduct thorough testing and evaluation of UAV systems to identify defects and areas for improvement. Collaborate with cross-functional teams to resolve issues and enhance system performance. Analyze data from tests and provide recommendations for process improvements. Stay up-to-date with industry trends and advancements in UAV technology. Participate in developing best practices and standards for testing UAV systems. Job Requirements Strong understanding of UAV technology and its applications. Experience with testing and evaluating complex systems. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Strong communication and interpersonal skills. Familiarity with industry standards and regulations related to UAVs.

Role & responsibilities To execute activities related to R&D Process Development, along with a group comprising of Research Officers/ Research Assistants under guidance from the Project Leader/Group Leade Require to Plan and carry out Chemistry related experiments, recording the observation in Protocol Computer literacy etc. Job Description: Literature search with respect to assigned project and its documentation Experimentation (Process development, optimization and validation) Analysis, interpretation (HPLC, IR, NMR, Mass and CHN) and documentation of data General Laboratory Management etc. Scale-up and Technology transfer activity Project related impurities synthesis.

Role & responsibilities 1. Pilot Plant Operations Management: Supervise and lead a team of technicians and operators to ensure efficient and safe operation of the pilot plant. Develop and implement standard operating procedures (SOPs) for various pilot plant processes and activities. Coordinate with cross-functional teams, including research and development, engineering, and analytical to ensure seamless integration and execution of pilot plant activities. Monitor and maintain equipment and instrumentation, ensuring their proper calibration and functionality. Troubleshoot and resolve operational issues to minimize downtime and optimize productivity. Ensure compliance with safety protocols, environmental regulations, and good manufacturing practices (GMP) during pilot plant operations. 2. Process Development and Optimization: Collaborate with R&D teams to design, develop, and scale-up new processes and technologies for pilot-scale production. Conduct experiments and trials to optimize process parameters, yields, and efficiencies. Analyze and interpret data generated from pilot plant experiments, identifying trends and recommending improvements. Work closely with engineers to evaluate and select appropriate equipment and technologies for pilot plant operations. Document and maintain comprehensive records of pilot plant activities, including process parameters, batch records, and deviations. 3. Project Management: Plan and execute pilot-scale production campaigns in accordance with project timelines and objectives. Coordinate with internal stakeholders to ensure timely availability of resources, materials, and utilities required for pilot plant operations. Monitor project progress and provide regular updates to management, highlighting any potential risks or deviations from planned schedules Collaborate with external vendors and contractors, as necessary, to procure equipment, supplies, and services for the pilot plant. 4. Training and Compliance: Train and mentor pilot plant staff on standard operating procedures, safety protocols, and quality standards. Ensure compliance with regulatory requirements, quality management systems, and company policies. Participate in audits and inspections, addressing any findings and implementing corrective actions. Stay updated with industry trends, technological advancements, and best practices related to pilot plant operations Preferred candidate profile Should possesses strong knowledge of chemical processes, unit operations, and equipment commonly used in pilot-scale manufacturing Familiar with process optimization techniques, statistical analysis, and experimental design Excellent leadership and team management skills, with the ability to motivate and inspire a diverse group of individuals Strong project management abilities, including the capability to prioritize tasks, manage resources, and meet deadlines Effective communication skills, both verbal and written, with the ability to interact with cross-functional teams, senior management, and external stakeholders Attention to detail, analytical thinking, and problem-solving skills Takes personal responsibility to make things happen and continuously raise the bar. Displays a high degree of emotional maturity and awareness of own impact. Defines and leads change initiatives for own work area Continuously raises the teams performance to best in class levels and creates a culture of high accountability

Please share your resume at anita.searchrx@gmail.com Role & responsibilities Reports to Associate Vice President / Designee. Plans and supervises assignments for next level team members. Conducts detailed process discussion with own & other teams then moulding the process as safe, robust and economic. Anticipates the scale up problems based on lab data and resolves the same before manufacturing. Prepares a list of negative experiments and provides suggestions from a scale-up point of view. • Attends, participates and drives meetings with team members. Trains or ensures training of team members for scale-up and introduction of new technologies. • Reviews all technical documents including lab validation data, analytical reports, and technical reports during lab validation. Review scale-up equipment selected by team members including material of construction. Review project progress with teams and individuals. Coordinate with other departments like AR&D, Manufacturing, Chemical Research & Development to make the scale-up plan and ensures smooth execution. Ensures safety awareness and implementation within the team. Review of plans for product allocation and its process development. Review and suggest experiments for process safety study and release report. Coordinate with Process engineers and R&D scientists so that process safety concerns are addressed prior to manufacturing batches. Understanding the capacity enhancement of scale up batches. CIP project validations. OPEX controlling of the process Preferred candidate profile • Understanding the capacity enhancement of scale up batches. • CIP project validations. OPEX controlling of the process. • Operational excellence is good to have an understanding. SIX sigma is added advantage Knowledge on handling the investigations and root cause analysis.

Job Objective : Good knowledge in Basic & Detailed engineering and Skilled in Technology transfer to understand lab batch observation and execute at plant / pilot scale. Technical / Functional 1) Scaling yup new products with process optimization from pilot scale which involves lab studies and validate plant batches. 2) To understand the inherent risk of manufacturing process, quality and yield impact of new process and to meet critical operating ranges as per requirements. 3) To prepare technology transfer report along with cross functional team and highlighting the requirements to execute the plan. 4) To prepare capacity utilization of all products each quarter as per marketing projection and understand bottleneck facility and execute action plan to de-bottleneck after all departments approval. 5) Planning of all products along with new CMS and intermediate products without any disturbances/lags and execute plan with 100% equipment utilization. 6) Looking after investigations with active participation in lab studies and also be part of CAPA proposal team. 7) To look after process optimization in yield and quality while trouble shooting in commercial scale. 8) Looking after solvent recovery improvements and implementing new techniques. 9) To perform both basic and detailed engineering as per the process requirements. 10) To take lead role while performing HAZOP and Risk Assessment for all newly transferred product to execute along with cross functional team. 11) To look after products timely deliveries from Raw material source and interacting with purchase to make plant under full utilization. 12) Coordination with R&D and support (Technical, pricing of RM) for completion of new product proposal/RFP. 13) New CMS and Intermediate products technical detailing will be done and will act as single point contract between R&D and plant. Based on requirement necessary follow up will be done with CFT team members (QA, QC, Purchase, Maintenance, Production and R&D) to ensure that project will complete and deliver within timeline.

As a Product Manager at Hyuman, you will play a crucial role in the end-to-end product development process, ensuring that our skincare products embody our commitment to self-care and innovation. You will lead the way from concept to commercial execution, driving technology transfer and liaising with vendors to deliver quality and intentional skincare solutions to empower women to feel confident in their skin. Your responsibilities will include managing the procurement of ingredients and materials, collaborating with internal teams for timely product launches, and ensuring consistency and quality throughout the product lifecycle. You will troubleshoot manufacturing issues, support lab testing, and assist Quality Control in upholding supply chain standards. Building strong relationships with vendors, suppliers, and R&D collaborators will be essential, along with identifying opportunities for innovation and efficiency within the vendor network. To excel in this role, you should have a Bachelor's degree in cosmetology, Chemistry, Pharmacy, or a related field, along with 2-3 years of experience in the personal care, cosmetics, or beauty industry. A strong understanding of product development and brand vision is crucial, as well as excellent communication and stakeholder management skills. You should be comfortable making agile decisions and multitasking across teams to drive the success of our skincare products at Hyuman.,

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will play a crucial role in leading method development, validation, stability studies, and technology transfer activities. Your meticulous nature and extensive experience will be essential in collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. You should possess strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement. Your responsibilities will include developing, optimizing, and validating analytical methods such as HPLC, GC, UV-Vis, and Dissolution according to ICH and regulatory guidelines. You will be responsible for preparing and maintaining validation protocols, analytical reports, and ensuring compliance with Good Documentation Practices (GDP). Additionally, you will oversee method transfer to QC, provide training, and address any troubleshooting issues that may arise. Conducting stability studies, preparing data reports, and collaborating with cross-functional teams to support product development will also be part of your role. Furthermore, you will be expected to investigate and resolve analytical issues, including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs) as necessary. Maintaining up-to-date documentation and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be integral to your responsibilities. You will also evaluate vendors and key starting materials (KSMs) and provide insights to management based on your findings. In terms of past experience, you should have a strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. Proven experience in method development, validation, and regulatory compliance is crucial for this role. Familiarity with global pharmaceutical regulations such as those from the FDA, EMA, WHO, and ICH guidelines is essential. You should also be skilled in handling regulatory submissions and documentation, possess excellent problem-solving abilities, and have experience mentoring R&D scientists. Familiarity with CAPA systems and good documentation practices will further strengthen your candidacy for this position.,

About Rubicon Research: Rubicon Research Limited is a fast-growing pharmaceutical formulation company dedicated to delivering value to customers and investors through the development, manufacturing, and marketing of branded specialty and generic prescription pharmaceutical products in regulated markets. With a product portfolio of over 250 SKUs across more than 70 product families, Rubicon Research has established a strong presence in the US market through its subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. The company operates two US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities. Headquartered in Thane, India, Rubicon Research also maintains a sales and marketing office in New Jersey, USA. For more information, please visit www.rubicon.co.in. Position Title: Senior Executive-Formulation Development Type: Full-time Location: Thane, Maharashtra. Key Responsibilities: - Develop new products and optimize existing formulations for various dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS) targeting regulated markets like the US, Europe, and ROW. - Conduct literature and patent searches, reviews, discussions, and documentation. - Perform API characterization, preformulation studies, and other related activities. - Plan and execute laboratory experiments on a daily basis. - Develop prototype formulas, optimize formulations and processes. - Prepare relevant documents such as MFC, BMR, STP, PDR, CPS, etc. - Collaborate with other departments including Stores, QA, RA, BD, IP sphere, CTS site, etc. - Coordinate with the Analytical Group for regular analysis of experimental samples. - Ensure effective execution of technology transfer activities at the manufacturing site. Qualifications & Pre-Requisites: - Master's in Pharmacy (Pharmaceutics). - Must-Have Skills: Formulation development experience in Solid & Liquid Oral products; experience with Pellets projects is preferred.,

As an Assistant General Manager (AGM) Formulation Development specializing in Injectable dosage forms, you will be responsible for the development, scale-up, and validation of both simple and complex formulations for Injectable products. Your primary focus will be on creating dosage forms compliant with regulations in the US, EU, India, Canada, Brazil, and other markets. Your key responsibilities will include: - Developing Injectable dosage forms for various global markets - Scaling up and transferring technology for Injectable products across different regions - Designing formulation strategies and overseeing the drug product development roadmap - Reviewing stability data of products under development and during validation batches - Handling regulatory queries and conducting studies as necessary - Coordinating with internal departments and external vendors for drug product development - Troubleshooting product and process failures, particularly for US, EU, and other markets - Providing technical guidance to subordinates and ensuring compliance with laboratory practices and safety regulations - Following Good Documentation Practices and Data Integrity requirements during GxP operations - Ensuring understanding and adherence to Data Integrity requirements and consequences - Reviewing data for compliance with Data Integrity requirements in the context of job responsibilities Your role will be crucial in ensuring the successful development and validation of Injectable dosage forms for multiple markets, requiring strong technical expertise, regulatory knowledge, and attention to detail.,

Role & responsibilities Review of Technology data package and preparation of Gap analysis document. Preparation of technology transfer protocol and report. Co-ordination with FD for smooth Tech Transfer. Monitoring of validation batches at production site. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. Review of MPCR and protocol. Planning for Execution of Process design, Process qualification batch. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. Should be part of handling deviation, change control and failure investigations. Process manufacturing parameters for Qualification batches Vs Commercial batches. Preparation and reviewing of intended batch documents for regulatory submission. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products. Preferred candidate profile required from OSD pharmaceutical Executive - TT: Exp required: 04 to 06 years Dy. Manager: Exp required: 09 to 12 Years Candidate should be willing to relocate/work in Nanjangud, Mysuru Plant.

Roles and Responsibilities Lead process development activities for hormone manufacturing processes, focusing on scale up and technology transfer. Develop and implement new technologies to enhance capacity and improve efficiency in existing processes. Collaborate with cross-functional teams to identify areas for improvement and optimize processing conditions. Ensure compliance with regulatory requirements during all stages of product development. Provide technical support to production teams to resolve issues related to process operations. Desired Candidate Profile 8-12 years of experience in pharmaceutical industry, preferably in hormonal manufacturing or similar field. B.Tech/B.E. degree in Chemical Engineering from a recognized institution. Strong understanding of chemical engineering principles, including mass transfer kinetics, heat transfer, and fluid mechanics. Experience with process development methodologies such as PFDs (Process Flow Diagrams), P&IDs (Piping & Instrumentation Diagrams), and SOPs (Standard Operating Procedures).

Technology transfer, scale-up at external/Third-party manufacturing/CMO sites. Coordinate with CMOs/internal teams for trials, validation and commercial production. Documents preparation for scale-up, validation and timely execution at CMOs. Food allowance Provident fund Health insurance

Raynas Infra & Geomatics services is looking for Drone Operator / Pilot (DGCA Pilot License) to join our dynamic team and embark on a rewarding career journey Operate drones for various applications. Conduct pre-flight and post-flight inspections. Ensure compliance with safety and regulatory standards. Maintain and update drone equipment. Collaborate with team members on drone projects. We required Geomatics Engineer with minimum Qualification of (BE/BA/Bsc/B-COM/B-tech/M-tech in any Stream) Working knowledge of Mission Planner Software and DJI Phantom 4 Pro V2,Idear Forge Nijja Drone.

Hiring for Process & Technology Transfer Engineer Dahej Qualification: BE Chemical Experience: 3 to 7 Years CTC: 6.5 LPA Female Prefer Send CV on sdpbharuch@gmail.com subject with : Process Dahej Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/IwMunSfhN5a4Aqvd1lVxpj Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

KEY FUNCTIONS / RESPONSIBILITIES Project initiation activities:- To understand project timelines and required activities for the timely execution. To perform literature search required for idea generation form (IGF) upon receiving IGF. To review DMF received from suppliers. To prepare product feasibility based on IGF received. To create the item codes for material and procure material and Reference Listed Drug (RLD). To assist AD lab for Q1 Q2 estimation of RLD. To draft tentative specification for API, RM and finished good. To plan laboratory trials and stability batches. To finalize proposed manufacturing process. To initiate filter validation process with the filter supplier. To handle Bead mill and high pressure homogenise . Documentation:- To prepare tech transfer documents including MFR, BOM, Process flowchart, Critical process parameters and critical quality activities. To review product specifications, manufacturing documents. To prepare documents for trial batches. To prepare product development report. To prepare and review SOPs and prepare response for internal audits. To review documents related to filter validation. Product Specification/ Tech Transfer/ Commercialization To organize and execute trial pre exhibit and exhibit batches at plant. To execute first three commercial batches at plant. To provide technical support for existing commercial batch. To perform investigation of failures during exhibit batches/ stability (Out of Specification). Innovation To come up with innovative and patentable formulations proposals. To come up with novel ideas which can reduce workload or expenses. Train, mentor and supervise the team To mentor RAs in planning the project activities in minute and actionable details. Help RAs in carrying out literature search. Help RAs in carrying out procurement of RLD, API and excipients. Plan and execute Knowledge sharing session for compatibility studies, reverse engineering, laboratory batches planning, filter compatibility, process optimization and recent updates in the field to emphasize importance of timeline adherence to team member

As a Senior Chemist in the Pharma Manufacturing Industry located in Vatva, Ahmedabad, your role will involve utilizing your M.Sc. in Organic Chemistry and 5 to 8 years of experience in API / Intermediates manufacturing within the pharmaceutical sector. Your responsibilities will include hands-on experience in the synthesis of APIs and intermediates, conducting literature searches using platforms such as SciFinder, Chemical Abstracts, Free Patent Online, and Journals. You will be involved in feasibility studies, route selection for synthesis, multi-step synthesis, yield improvement, and cost reduction strategies. Additionally, you will be responsible for tasks such as extraction, purification, distillation, lab validations, process development with strong documentation including Tech reports, process safety reports, and cost sheets. Furthermore, you will lead technology transfer from the laboratory to kilo lab and plant scale, while coordinating with IPR, Regulatory Affairs, and QA departments. Proficiency in tools like Chemdraw / Chemsketch is essential for this role. Please note that only male candidates from the Pharma Manufacturing Industry will be considered for this position. If you are seeking a challenging full-time, permanent role that requires your expertise in organic chemistry and pharmaceutical manufacturing, we look forward to receiving your application. With Regards, Himani(HR) 9377165778,

As a Manager-II in the MSTG department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide support for the execution and monitoring of trial, scale up, exhibit process qualification batches. You will be involved in preparing and reviewing new product documents such as material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols. Additionally, you will be required to prepare regulatory responses and share process knowledge with cross-functional departments through presentations for smooth technology transfer. You will play a key role in reviewing and evaluating product history and process parameters for technical remediation and improvement of product robustness. Your duties will also include preparing and submitting investigation reports for OOS, OOT, and any failure during exhibit/validation/commercial batch manufacturing and stability testing. Furthermore, you will be responsible for tracking activities related to change control, CAPA, planned deviations, unplanned deviations, and more. Your role will involve preparing and reviewing product containment approaches, risk assessment reports for new products, elemental impurities, Nitrosamine impurities, and residual solvent. You will also be tasked with arranging placebos for quality control testing, change part development, and evaluating the feasibility of products. Statistical evaluation for process assessment, preparation and review of standard operating procedures, training schedules, conducting training sessions, and participating in regulatory audits to support the plant will also be part of your responsibilities. Overall, as a Manager-II in the MSTG department, you will be at the forefront of ensuring the quality and compliance of processes and procedures while contributing to the continuous improvement and development of new products within the organization.,

Job Title: Dy Manager R&D-Technology Transfer Location : Mumbai Location Industry: Pharma Industry Experience: Minimum 5.to 10 years . Able to scale up technology from R&D to Kilo scale/ pilot scale/ commercial scale Coordination with R&D team for generating negative study data, concluding to optimize process parameters interested candidates can share cv to hr3@sarthee.com or call at 9033033650

Role & responsibilities Experience in the development of Generic APIs Development / improvement of the assigned products and overall review of development activities. To finalize route based on literature or feasibility of process or availability of raw materials. Technology transfer, scale-up and troubleshooting To provide required relevant information for regulatory filing and response to regulatory queries. To prepare and review documents Maintain the development records and overall review of given projects. To maintain records as per IMS requirements. Preferred candidate profile Must have experience in the development of Generic APIs

Responsible for scale up technology from R&D to Kilo scale/ pilot scale/ commercial scale Coordination with R&D team for generating negative study data, concluding to optimize process parameters Observe R&D demo batches & preparation of demo batches report Identify & propose ideas to improve process efficiency, effective utilization for unit process & operations Preparation of BFD, PFD, P&ID, mass balance, energy balance sheets Monitor process optimization & validation batches at pilot/ commercial scale at different manufacturing sites Support the external job work activity to achieve desired yield and quality Coordination with cross functional teams to implement process through scale-up & capacity enhancement Preparation of optimization & validation campaign reports after completion of projects

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for prior art, and establish proof of concept through experimentation. Collaboration with cross-functional teams including Manufacturing Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), and production teams across different geographies will be crucial for technology transfer and timely execution of submission batches. Your role will also involve identifying challenges, bottlenecks in development, and providing mitigation proposals at various stages of product development. Furthermore, you will be responsible for problem-solving, prioritizing activities, conducting development trials, and ensuring alignment with established milestones. Clear communication with internal stakeholders, proactive identification of challenges or risks, and adherence to business unit Key Performance Indicators (KPIs) will be essential aspects of your role. On a day-to-day basis, you will work closely with the formulation development teams to achieve key milestones, conduct experiments following QbD principles, and prepare presentations at different stages of product development. Your tasks will include literature reviews, sourcing API and Excipients, conducting preformulation studies, executing development trials, interpreting analytical data, and preparing necessary documentation for regulatory submissions. To be successful in this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 1 year of experience or an M.Pharm in Pharmaceutical Sciences with a minimum of 3 years of experience from reputable universities. Prior experience in working with generic pharmaceuticals in regulated markets such as the US, EU, or Canada will be advantageous. Your commitment to personal accountability, effective work habits, continuous learning, and collaboration with internal teams will be instrumental in contributing to the success of our organization's mission to make good health more affordable and accessible globally.,

KPMG India is looking for Executive - Government Technology Executive - Government Technology to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

l Interaction with R&D department for new product development l Equipment mapping for kilo lab and kilo lab to pilot plant. l Responsible for preparing BPCR,PCOCR l Responsible for lab demonstration in R&D l Study of new product in R&D and plan batch in pilot scale l Planning for raw materials for batch trial. l Enquiry floating of equipment and technical clearance of equipment. l Responsible for scale up activities of new projects as well as cost reduction of product and waste reduction. l Able to lead subordinate technology transfer process engineer team l Planning and resource management for continuously pilot plant operation. l Equipment selection, Process mapping, Time cycle calculation, Volume calculations for new product . l Responsible for material balance and energy balance of product. l Utility calculation,hydraulic calculation and cost estimation of new products l Identify and analyze bottlenecks,implement best practice and continuous improvement for process optimization. l Optimize resource utilization,reduce waste for process efficiency. l Capacity calculation capacity enhancement for any new or existing products. l Plant development, Plant validation batches report preparation. l Detailed workout for equipment modification along with detailed job list & PFD for scale up purpose

Role & responsibilities To perform the Technology transfer of Product from R&D to Site receiving activities and QMS related activities at the manufacturing plant . To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. To provide technical support for change management, investigations of deviations or OOS, CAPA identification and QMS related activities at plant. Ensure cGMP and Regulatory compliance.