113 Tech Transfer Jobs - Page 5

Job Description Company: Emcure Pharmaceuticals Ltd. Role: Officer/Executive Department: Technical Services Location: Kurkumbh, Pune. Observations of Demo Batches at R&D for NPI/CIP Projects. Provide what-If Parameters to R&D. Review of all Trial & Validation related documents. Execution of Trial & Validation Batches. Arrange Cross Function Team Meeting at Site for NPI/CIP Projects execution. Imparting training to Cross Function Team at KK for NPI/CIP. Identify Modification Requirements for NPI/CIP. Preparation of Process Flow Diagram and Piping & Instrumentation Diagram. Engineering calculations & equipment mapping for new products at Kurkumbh & F-II site. Sample arrangement from ongoing projects (Trial Batches) to R&D from Kurkumbh site. Preparation of Quality Risk Management Study. Trial batches executed BMR, Protocol submission to DQA. Review of Validation documents at Contract Manufacturing Organization/site. Review of Raw Material consumption for Validation campaign at Contract Manufacturing Organization/site.

Execute and manage technology transfer of OSD products from R&D to manufacturing. Coordinate and monitor scale-up and exhibit batches in line with regulatory requirements. Ensure USFDA and other regulatory compliance throughout product development and scale-up. Prepare and review tech transfer documents , protocols, and reports (BMRs, MFRs, PVPs, etc.). Support investigation and troubleshooting of manufacturing issues, and suggest process optimization. Collaborate with cross-functional teams: R&D, QA, RA, Manufacturing, and SCM. Participate in audits and provide technical support during regulatory inspections. Drive continuous improvement initiatives to enhance productivity, cost efficiency, and quality. Qualifications: B.Pharm / M.Pharm in Pharmaceutics or related discipline. 7-11 years of relevant experience in Tech Services Hands-on experience with OSD formulations, preferably for the US market . Proven experience in scale-up , exhibit batches , and tech transfer. Strong understanding of regulatory guidelines (USFDA) Excellent documentation, communication, and cross-functional collaboration skills.

Sun Pharmaceutical Industries Ltd. Position: Senior Manager API Production (Block Head) Grade: G9B Location: API Ahmednagar - Production Planning and scheduling (day to day basis) - Ensuring resources available (BMR, Raw Material Manpower etc.) Liaison with QC/QA/STORE/Eng. Dept. for solving of trouble shooting problem. - Implementation and monitoring of GMP Standard. - Introduction and scale up of technology transfer. (New Prod 1ct) Constantly monitoring and improvement of product process, efficiency, services etc. - Documentation work, Monthly Report, data preparation (Process trend analysis) and root cause analysis. - Ensure the availability of consumable items & Planning of RM require as per campaign basis. - Ensure the documents related to process I cleaning / House Keeping. Control on fresh as well as recovered solvents/ spent solvent. - Ensure the solid and process waste transfer to respective area and record maintaining. - Other activities entrusted from time to time. Review the prepared/ Revision of BMR and SOP. - Operation of electronic system i.e.ONE HR portal, Metis Track wise, Minitab, Out Look etc. - Ensure Preventive Maintenance of Plant Equipment's in time frame. Ensure the training to subordinates. - Extended Facility of reactor Area of Plant-06 production Planning and scheduling (day to day basis)

Key Responsibilities: - Technology Transfer: • Assist in managing the technology transfer process for new products and process for new products and processes from R&D to commercial production. • Collaborate with cross-functional teams including R&D, Manufacturing, Quality and Regulatory Affairs to facilitate successful technology transfer within specified timelines and quality standards. • Contribute to the development and implementation of strategies to mitigate risks associated with technology transfer process. Process Engineering : • Support process engineering activities aimed at optimizing manufacturing processes for efficiency, scalability, and cost effectiveness. • Participate in identifying opportunities for process improvements, conducting studies, and implementing solutions to enhance product quality and yield. • Assist in providing technical guidance to the engineering team to drive continuous improvement initiatives. Compliance and Documentation: • Assist in ensuring compliance with regulatory requirements and industry standards throughout technology transfer and process engineering activities. • Review documentation related to technology transfer, process optimization and validation protocols as needed. Cross Functional Collaboration : • Work collaboratively with other departments to facilitate smooth technology transfer and process improvements. • Support Quality Assurance and Regulatory Affairs in regulatory filings and inspections as required. Leadership and Development: • Support Head of MSTG in providing leadership, mentoring and guiding to the MSTG team, promoting a culture of innovation, teamwork and continuous learning. • Identify training needs and development opportunities for team members to enhance their skills and capabilities. Interested candidates forward resume on anuverma@scllifesciences.com or Whats app/ call on 9988339860.

Technology Transfer professional to support seamless scale-up and integration of new products/processes from the production floor. The role bridges development and manufacturing, ensuring process understanding, compliance, and efficiency.

Role & responsibilities • To receive and understand the technology from FnD dept. • To design optimisation for process parameters & participate in the trials at R&D. • To transfer the technology from R&D to receivers site for the respective product. • To monitor the TT demo / exhibit/scale up and optimization batches. • To review the technical information sheet, product detail, raw material/accessories/ equipment requirement for plant trial/SU/Exhibit batches. • To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements. • To get involved and observe in the TT demo batch with F&D. • To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc. • To take the exhibit batches at the manufacturing locations and take care for its trouble shooting. • To prepare the summary reports. • To perform investigation for Deviation/ OOS/ OOT observed during SU/EB at plant. To prepare agency query responses.

Roles and Responsibilities 1. Review of Technology data package and preparation of Gap analysis document. 2. Preparation of technology transfer protocol and report. 3. Co-ordination with FD for smooth Tech Transfer. 4. Monitoring of validation batches at production site. 5. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. 6. Review of MPCR and protocol. 7. Planning for Execution of Process design, Process qualification batch. 8. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. 9. Should be part of handling deviation, change control and failure investigations. 10. Process manufacturing parameters for Qualification batches Vs Commercial batches. 11. Preparation and reviewing of intended batch documents for regulatory submission. 12. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products.

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

Role & responsibilities 1. Development of stable, bioequivalent pellets dosage form (IR/ SR/ DR/ ER/ MUMPS) 2. Efficient technology transfer of pellets projects from R&D to plant level. 3. Closely working with Plant tea for trouble shooting of ongoing commercial pellets projects. 4. Oversee all aspects of pellets dosage form including planning, execution, and innovation strategy. 5. Evaluation and implementation new technology for pellets product development. 6. Collaborate with internal team and external partners for project success. Preferred candidate profile 1. Strong expertise in pellets dosage product development and its technology transfer to plant. 2. Strong analytical and problem-solving skills with a proactive approach. 3. Ability to align R&D strategies with business goals, 4. Excellent communication and stakeholder management abilities.

Vibonum Technologies Pvt Ltd (Althera Groups) is hiring Technology Transfer Executive for its OSD Pharma manufaturing plant at Nanjangud, Mysore. 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: 03 to 06 years with M. Pharm Candidate should be willing to relocate/work in Nanjangud, Mysuru Plant. Benefits: Free canteen facility Free transport facility Medical Insurance All Statutory benefits etc.

Key Responsibilities: - An executive with extensive expertise in Biologics Manufacturing: Product Technical Life Cycle Management. - Lead MSAT cell culture upstream projects and technical investigator. - Planning and designing using DOE approach for process development and characterization of upstream operations. - Working as team with other cross functional teams and contributing the domain expertise for advancing the pipeline molecules as required. - Identify opportunities for improving the product quality and quantity as per current and future market demand. - Hold time study of all process intermediate, reagent, media & Feed. - Perform all functions associated with process transfer and scale up to manufacturing e.g. develop process understanding, perform gap analysis / FMEA / RCA, generate process models, author / review process descriptions and batch Records, support equipment commissioning, process training, and validation activities. - Perform all functions associated with process monitoring, trending of in process and lot release parameter and quality data by using various software tools e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes. - Continuous monitoring of manufacturing batches of assigned projects. - Review of protocol, study report, SOP and review of lab documents. - Play a member role in resolving technical issues for all functions to improve compliance throughout the site. Serve as investigation team member for process-impacting deviations and investigations. Provide technical guidance on change controls and how they might impact the processes and product specifications. - Statistical data analysis & Develop the Statistical model for the batch monitoring.

Key Responsibilities • Responsible to understand the New process/ Tech transfer during the walk through and ensuring the facility accordingly. • Responsible to Plan and completing line modification activities as per Execution plan (based on the process requirement). • Responsible to review the change control for site initiation for New Product/ Stage/ Campaign. Accordingly arranging the other documents to execute batch in the plant like Tech pack, Risk assessment, PSSR, PID etc. • Responsible for co-ordinating with other departments like Warehouse, Engineering, QC, Process Engineering, PR&D, HSE & QA to complete start up activities as per the time line. • Review process with respect to Quality, Safety, Yield, and Waste management, availability of Utility source and accessories. Collecting relevant details from PE & PR&D to execute the batch smoothly. • During initiation of New product/ stage or change in process, training shall be imparted to concern subordinates and Production team. • Responsible to track the batch status w.r.t Quality, Yield, Cycle time according to dispatch time line by co-ordination with Production team. • Verifying data with respect to critical parameters, purity and yield along with batch cycle time of previous batches before executing new campaign / batches. • Responsible to report the deviations/ observations /abnormalities immediately to Superiors & Concern persons. • Responsible to complete the investigation (Product deviation & OOS) w.r.t process. • Responsible for technical troubleshooting the problem araised during process execution. • Responsible for ensuring safety practices & instruct to subordinates for the same. • Responsible to ensure the RM approved stock availability in advance for batch charging to meet dispatch target. • Responsible for assigning job and monitoring team members work deliverables. No. of Reportees 12 to 18 years of process engineering experience. Qualification & Experience M.Tech /B.Tech Chemical Engineering with 13+ years exp. Key Competencies (Technical, Functional & Behavioural) Excellent verbal and written communication, persuasiveness, inter-personal skills, adaptability, foresight, understanding of business processes

Job Description: Department: Formulation R&D Experience: 3 - 7 Yrs. Qualification: M.Sc / M.Pharma Skills: Should have prior experience and knowledge of development of Soft Gelatin Capsules Technical Documentations - BOM / MFR stability study guidelines , QMS knowledge of pharmaceutical development Technology Transfer to commercial site Should have knowledge of development of other dosage forms (Solid Orals / Liquids /Semi-solids) Good to have knowledge on Nutra / Ayurvedic Regulations