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1.0 - 3.0 years
2 - 4 Lacs
Gurugram
Work from Office
Job Title - R&D Chemist Experience: 4+ years in R&D Industry- Leading pharma, CRO (Contract research Organization), Agrochemicals JOB DUTIES AND RESPONSIBILITIES (Please mention in below table) Plan, setup, monitor, and workup chemical reactions independently Monitor progress of the reactions by using standard methods and analytical techniques (TLC, GC, HPLC, LCMS etc) Isolate product and Optimize reaction conditions for improved yields and output Purify compounds by different methods using chromatography, distillation and crystallization etc. Characterization and identification of compounds using UV, IR, NMR, LCMS and GCMS etc Ensure parallel execution of multiple reactions conducted both by self and the team Scale up of R&D developed products to kg scale and then technology transfer to pilot plant Troubleshoot as appropriate for successful execution with intimation to supervisor Pls sent your resume mentioning the Below details Present CTC : Expected CTC: Company Name : Current Location: Notice Period: Native Place : If any candidates is suitable for this opening please sent me your updated profile on this mail id.
Posted 1 month ago
3.0 - 8.0 years
4 - 7 Lacs
Bharuch
Work from Office
R & D (Synthesis) For Agrochemical Industry in Saykha,Gujarat. Capital Placement Services 3 - 8 years 4-7 Lacs P.A. Bharuch, Ahmedabad, Vadodara Monitor progress of the reactions by using standard methods & analytical techniques (TLC,GC,HPLC, LCMS etc).Plan, setup, monitor, and workup chemical reactions independently.Isolate product & Optimize reaction conditions for improved yields & output Required Candidate profile Scale up of R&D developed products to kg scale and then technology transfer to pilot plant
Posted 1 month ago
1.0 - 5.0 years
3 - 6 Lacs
Patancheru, Hyderabad
Work from Office
Job Purpose: To support and lead technical initiatives such as process scale-up, troubleshooting, and capacity enhancement in API manufacturing, ensuring smooth technology transfer and continuous process improvements for optimized productivity and quality. Key Responsibilities: Assist in process scale-up from R&D to plant scale, ensuring smooth technology transfer and implementation. Support and lead process troubleshooting to resolve deviations, yield losses, and quality concerns. Drive capacity enhancement initiatives through debottlenecking and cycle time reduction. Collaborate with R&D, production, QA, and EHS teams for process validation and continuous improvement. Prepare and review process documents such as PFDs, P&IDs, Batch Manufacturing Records (BMR), and SOPs. Monitor critical process parameters and support investigations for any abnormalities. Conduct data analysis and root cause analysis (RCA) to optimize existing processes. Participate in audits and regulatory inspections by providing technical justifications. Ensure adherence to cGMP, safety, and environmental standards during implementation. Support new product introduction (NPI) and pilot batches in coordination with cross-functional teams. Required Skills & Competencies: Strong understanding of chemical engineering principles and API manufacturing processes Hands-on experience in process scale-up and technology transfer Knowledge of cGMP guidelines , safety protocols , and regulatory requirements Proficiency in root cause analysis, process troubleshooting , and documentation Analytical mindset with strong problem-solving abilities Good communication and team coordination skills
Posted 1 month ago
10.0 - 18.0 years
9 - 13 Lacs
Mumbai, Pune, Bengaluru
Work from Office
Immediate job opening for # SAP Cutover Manager_C2H_Pan India. Skill: Sap Cutover Manager Exp: 10+Years Location: Mumbai, Bangalore, Pune Job description: Must have demonstrated experience and a track record of success as Cutover Manager Lead on ERP transformations. Demonstrated through At least five years prior experience in having led SAP cutovers. Must have enterprise scale experience Develop and own the overall Deployment workplan. This should contain a list of deliverables and activities that will be executed by the Deployment workstream. Liaise with project teams to develop a detailed integrated cutover which include both technical and functional steps to be executed during the deployment phase. Identify risks, cross application dependencies and downstream impacts for each release. Manges risks and issues associated with the cutover and prepare appropriate mitigation plans Create and maintain a detailed Integrated Cutover Project Plan from inception, execution, and post-implementation. Determine go-live readiness criteria, socialize them with key stakeholders and obtain requisite approvals Plan and execute mock cutovers to help teams prepare for the final production cutover Responsible for ensuring successful planning and execution of integrated release cutover activities and associated systems outages Leads cutover activities for Pre Go-Live, Go-Live and Post Go-Live Coordinates requirements for Go Live Monitor data and cutover progress and communicate to leadership team including status, progress. Manage the scope and schedule of cutover activities Provide detailed backout options for severe contingencies Ensure compliance with IT processes including proper documentation and securing approvals of requisite changes through our Change Advisory Board process Provide timely escalation to IT leadership where necessary. Liaise with the functional SAP experts and business teams in order to assist with the planning and execution of Deployment activities. Plans the resources, human and physical required for cut-over activities. Develops the communication and escalation plan. (policies, procedures, downtime processes etc Provides Cutover status reporting to the project leadership and key stakeholders. Ensures entry into and exit out of cutover stage gates are met including the final Go/No-Go meetings. Acts as the final point of escalation for all Cut-over issues, proactively bringing about appropriate interventions when the Cutovermay be jeopardized.
Posted 1 month ago
9.0 - 14.0 years
9 - 13 Lacs
Hyderabad
Work from Office
Must have demonstrated experience and a track record of success as Cutover Manager / Lead on ERP transformations. Demonstrated through At least five years prior experience in having led SAP cutovers. Must have enterprise scale experience Develop and own the overall Deployment workplan. This should contain a list of deliverables and activities that will be executed by the Deployment workstream. Liaise with project teams to develop a detailed integrated cutover which include both technical and functional steps to be executed during the deployment phase. Identify risks, cross application dependencies and downstream impacts for each release. Manges risks and issues associated with the cutover and prepare appropriate mitigation plans Create and maintain a detailed Integrated Cutover Project Plan from inception, execution, and post-implementation. Determine go-live readiness criteria, socialize them with key stakeholders and obtain requisite approvals Plan and execute mock cutovers to help teams prepare for the final production cutover Responsible for ensuring successful planning and execution of integrated release cutover activities and associated systems' outages Leads cutover activities for Pre Go-Live, Go-Live and Post Go-Live Coordinates requirements for Go Live Monitor data and cutover progress and communicate to leadership team including status, progress. Manage the scope and schedule of cutover activities Provide detailed backout options for severe contingencies Ensure compliance with IT processes including proper documentation and securing approvals of requisite changes through our Change Advisory Board process Provide timely escalation to IT leadership where necessary. Liaise with the functional SAP experts and business teams in order to assist with the planning and execution of Deployment activities. Plans the resources, human and physical required for cut-over activities. Develops the communication and escalation plan. (policies, procedures, downtime processes etc Provides Cutover status reporting to the project leadership and key stakeholders. Ensures entry into and exit out of cutover stage gates are met including the final Go/No-Go meetings. Acts as the final point of escalation for all Cut-over issues, proactively bringing about appropriate interventions when the Cutovermay be jeopardized. Please Share below details and Updated Resume: MatchedYes/No:Full Name with Surname:DOB:Adhacard No(Mandatory):Alternate Contact Number:Total Experience:Relevant Experience:Current Location:Preferred Location:Current CTC :Expected CTC :Current Organization/ Contract with Current Org :Payroll Company:Notice period :Passport/ Expiry Date:Holding any offerYES/NO:
Posted 1 month ago
6.0 - 10.0 years
6 - 9 Lacs
Hyderabad
Hybrid
Notice Period Immediate Primary Skills: Azure admin, Scale Sets, VM administration, Windows fileserver, Load Balancers, SQL server RDS, Azure Managed Disk, Basic networking, .NET Job Details Hand-on experience in Scale sets, .NET, Azure DNS, ALBs.Networking knowledge to understand the various components between cloud and on-prem infrastructure.Identify and resolving connectivity issue by opening ports, get through firewalls, NSG, whitelist ip addresses on both on-prem and Azure envs.Configure database connectionsConfigure VM image backups, Azure Managed Disk replication, Configure and Test DR solution.Configure SQL server RDS replication on DR site
Posted 1 month ago
8.0 - 13.0 years
10 - 16 Lacs
Chandigarh
Work from Office
Company Name: SCL Lifesciences Ltd. Position: Assistant Manager / Deputy Manager Department: MSTG Location: - Chandigarh COMPANY PROFILE: - SCL Lifesciences Limited is a 30-year-old API manufacturing company with two manufacturing units located in Derabassi five KM from each other -one for domestic supplies and another for exports. We have USFDA, EU-GMP, WHO Geneva, KFTA, PMDA, and TGA, Australia certifications thereby opening the global markets. SCL lifesciences believes in the planet, people, and profits and has a dedicated cell for CSR working in rural schools. It has doubled its profits and turnover in the last three years and is being run by a professional board of both executive and independent directors. Job Summary: As the second in command of MSTG at SCL, you will support the Head of MSTG in overseeing and leading the Technology Transfer and Process Engineering activities within the API manufacturing division. You will assist the ensuring the smooth transfer of technology from development to manufacturing while optimizing process to meet efficiency and quality objectives. KeyResponsibilities:- 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 forprocess 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. Requirements: ¢ A minimum of a B.Tech (Chemical) or M.Tech (Chemical) or a related field is required. ¢ Proven experience (at least 10-15 years) in process engineering and technology transfer in API manufacturing. ¢ Strong knowledge of chemistry, process engineering principles, and pharmaceutical manufacturing processes. ¢ Familiarity with regulatory guidelines and requirements related to APImanufacturing and technology transfer. ¢ Experience in leading cross-functional teams and managing complex projects from development to commercialization. ¢ Excellent problem-solving skills with the ability toanalyze complex issues, identify root causes, and implement effective solutions. ¢ Strong leadership and team management abilities, with a track record of mentoring and developing talent. ¢ Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders. ¢ Detail-oriented mindset, with a commitment to quality, compliance, and continuous improvement.
Posted 1 month ago
1.0 - 6.0 years
2 - 5 Lacs
Vadodara
Work from Office
Role & responsibilities Knowledge about chemical reaction and chemical compounds. Awareness about R&D lab Instruments and Glassware. Setting up lab experiment assembly like reaction, distillation, vacuum distillation, separation, etc. Ensuring experiments are carried out safely and carrying out risk assessments. Maintain complete records of experimental results and analysing data of experiments. Optimize reaction conditions and troubleshoot technical issues. Ensure consistency and repeatability of process to get acceptable yield and quality. Preferred candidate profile M.Sc. in Chemistry having 1-6 Years Experience in R&D Synthesis having Chemical and Pharmaceutical Industry having problem-solving and decision-making skills, Strong analytical and organizational skills . Additional Information: At Avid Organics, we believe that we can achieve our mission to enhance value creation for our stakeholders only through the quality and commitment of our people. We continuously strive to unleash the potential of each individual. We leverage human capital for competitiveness by nurturing knowledge, entrepreneurship, and creativity. These strengths help us compete successfully in a global business environment and exploit emerging opportunities. We reward the will to succeed and the desire to compete with the best in the world. Our employees are intellectually stimulated and given the freedom to make their own decisions, driving our growth through innovation and experimentation. Apply Now! :- hr@avidorganics.net Visit our website apply us at https://www.avidorganics.net
Posted 1 month ago
0.0 years
1 Lacs
Dahej
Work from Office
Role & responsibilities: Candidates will have to work on Apprenticeship Training for one year. If your performance is excellent we will consider you for permanent job role opportunity. Department: Formulation Technology Transfer Preferred candidate profile: Candidates should have the below mentioned % criteria: In 10th & 12th Candidate should have 60% aggregate or above of both the classes. Candidates should not have any kind of ATKT/Backlog throughout M. Pharm degree. Location: Dahej, Gujarat Stipend: Rs. 12,000 per month (Fixed) Interested candidates please share your updated CV's on hrdahej@torrentpharma.com.
Posted 1 month ago
3.0 - 6.0 years
5 - 12 Lacs
Hyderabad
Work from Office
Walk-in Interviews: Process R&D & Process Engineering | 28th June'25 | Hyderabad Are you a seasoned Process R&D Scientist or Process Engineer driven by the intricacies of pharmaceutical scale-up and optimization? Aurigene Pharmaceutical Services Ltd, a leading CDMO at the forefront of drug development, is strategically expanding its core technical teams. We are seeking distinguished scientific and engineering professionals whose expertise will directly shape our advanced API development and manufacturing processes. This is an invitation to leverage your specialized knowledge and make a tangible impact within a high-growth environment. Positions Available: 1) Scientist - Process R&D (API) - Qualification & Experience: M.Sc . (Chemistry) with 3 - 6 years of experience - Responsibilities: Driving process optimization, scale-up (mg to kg), technology transfer, analytical interpretation (IR, NMR, Mass, GC, HPLC), documentation, and troubleshooting - Added Advantage: Flow chemistry experience 2) Team Member - Process Engineering - Qualification & Experience: B.Tech . Chemical Engineering with 3-6 years of - industrial experience - Responsibilities: Ensuring process feasibility, safety & compliance during scale-up, executing technology transfer, overseeing batch operations, and leading cost optimization initiatives Walk-in Interview Details: Date: Saturday, 28th June, 2025 Time: 9:00 AM to 12:00 PM Venue: Aurigene Pharmaceutical Services Ltd, Bollaram Road, Jaya Prakash Narayan Nagar, Miyapur, Hyderabad, Telangana 500049 Please remember to bring: - Your updated resume - Latest appraisal letter - Last 3 months' salary slips We look forward to meeting passionate individuals ready to make an impact!
Posted 1 month ago
6.0 - 9.0 years
6 - 8 Lacs
Bengaluru
Work from Office
We are seeking a highly skilled and motivated Drug Product Development Scientist to join our dynamic team focused on developing biologic drug products. The ideal candidate will have extensive experience in the formulation, development, and scale-up of biologic drug products, such as monoclonal antibodies, vaccines, and gene therapies. The Ideal candidate would have: 5+ years of experience in drug product development preferably in the Biologics space. Candidate is expected to have hands on experience (not limited to) on analytical techniques like, HPLC, UPLC, Lyo, Karl Fischer, Solo VPE, MFI etc. Stability study: designing, protocol drafting, data evaluation and reporting Process related documents like FMEA, risk assessments, process characterization. specifications, TTD, etc. Basic idea of various regulatory filing and their requirements Understanding on filter validation Good communication skill (writing and verbal) Attitude to collaborate Required Qualifications: Education & Experience : BS/MS degree in Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemical Engineering, or related field. experience in drug product development for biologics (e.g., monoclonal antibodies, vaccines, gene therapies). Strong knowledge of formulation science, particularly in biologic drug products (injectable solutions, lyophilized products, etc.). Experience in GMP (Good Manufacturing Practices) and regulatory compliance for biologics. Hands-on experience with bioreactor operations, protein purification, and bioprocessing techniques is highly desirable.
Posted 1 month ago
1.0 - 6.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Walk-In Drive For Technical Service Department(TSD)- MSN Laboratories, Pashamylaram, R&D center on Friday 27-06-2025. Role & responsibilities Knowledge of process engineering activities from lab development to commercial execution. Process engineering calculations for scale up . Preparation of technology transfer documentation like PFD, P&ID, and equipment suitability. Supporting research team in generating safety data Knowledge of HAZOP/HIRA Conducting simulation experiments in lab Batch monitoring during manufacturing to ensure smooth scale up Preparation of campaign reports after the completion of the project for knowledge transfer. Department : TSD Qualification: B.Tech Chemical Engineering Designation : Executive/Sr Executive Job Location MSN R&D Center Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue Details :Venue Details : MSN Laboratories Pvt. Ltd, R&D Centre, Pashamylaram (V), Patancheru (M), Sangareddy (D.t), Telangana Friday 27-06-2025. Please share CV to dinesh.baratam@msnlabs.com Subject TSD Profile
Posted 1 month ago
5.0 - 6.0 years
4 - 5 Lacs
Kadi, Ahmedabad
Work from Office
Role & responsibilities Cell Culture & Production Support: Perform aseptic handling and maintenance of cell cultures (e.g., Vero, BHK or other cell lines) in adherent and/or suspension formats. Prepare and sterilize culture media, buffers, and reagents as per batch requirements and SOPs. Monitor and record cell growth parameters, viability, and morphology. Scale-up cell cultures for downstream processing or viral seed production. Facility & Environmental Monitoring: Conduct routine facility checks including temperature, humidity, pressure differentials, and cleanroom conditions. Coordinate and ensure compliance with environmental monitoring schedules (viable/non-viable particles, surface, and air sampling). Assist in maintaining facility readiness and hygiene per cGMP standards. Documentation & Quality Compliance: Prepare and review SOPs, batch manufacturing records (BMRs), logbooks, and calibration/maintenance records. Maintain data integrity and compliance with Good Documentation Practices (GDP). Participate in internal and external audits, ensuring timely closure of CAPAs. Quality Management System (QMS): Support implementation and maintenance of QMS elements: deviations, change controls, CAPA, risk assessments, and document control. Participate in training programs related to QMS and GMP compliance. Working knowledge of QMS software/tools is an added advantage. Desired Skills: Proficiency in aseptic techniques and cleanroom operations. Strong understanding of GMP, GLP, GDP, and ISO standards. Good written and verbal communication skills. Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi)
Posted 1 month ago
2.0 - 6.0 years
3 - 7 Lacs
Mumbai
Work from Office
- Responsible for the availability of raw materials as per lab requirements -To analyse quality results and discuss the experimentation plan with Research Incharge. - Understand the safety aspects of all reactions and chemicals to be used - Ensure the setup ( reaction assembly, distillation, filtration, reaction work-up, crystallization) as planned - Carry out reaction process as per the provided plan, get the analysis done of raw material , in process reaction intermediate and product - Record all observations and give suggestions for improvement - Ensure proper housekeeping of the lab - Maintain highest safety practices while working by using required PPEs (Personal protective equipment) - Maintain the log sheets of all the experiments regularly with critical observations and feed the data into Electronic Lab Notebook (ELN) - Stack of all the chemicals & glassware as per 5S (sort, set-in-order, shine, standardize, sustain) - After reaction completion, decontaminate the glass apparatus
Posted 1 month ago
2.0 - 6.0 years
3 - 7 Lacs
Vapi
Work from Office
- Responsible for the availability of raw materials as per lab requirements -To analyse quality results and discuss the experimentation plan with Research Incharge. - Understand the safety aspects of all reactions and chemicals to be used - Ensure the setup ( reaction assembly, distillation, filtration, reaction work-up, crystallization) as planned - Carry out reaction process as per the provided plan, get the analysis done of raw material , in process reaction intermediate and product - Record all observations and give suggestions for improvement - Ensure proper housekeeping of the lab - Maintain highest safety practices while working by using required PPEs (Personal protective equipment) - Maintain the log sheets of all the experiments regularly with critical observations and feed the data into Electronic Lab Notebook (ELN) - Stack of all the chemicals & glassware as per 5S (sort, set-in-order, shine, standardize, sustain) - After reaction completion, decontaminate the glass apparatus and give for further cleaning. - Segregate effluents as per the lab system
Posted 1 month ago
8.0 - 13.0 years
15 - 25 Lacs
Navi Mumbai
Work from Office
Experience in Process Optimization, quality control, Safety compliance, data analysis, Continuous improvement, Project management, documentation Scaleup & technology transfer for different processes from R&D & finally to Commercial plant Required Candidate profile Strong knowledge of chemical manufacturing processes & equipment 10 years of experience as a Process Engineer in the specialty chemicals/ Pharma/ Aroma Chemicals industry
Posted 1 month ago
2.0 - 7.0 years
3 - 7 Lacs
Panch Mahals, Halol, Vadodara
Work from Office
Department: Technology Development Group (Kilo Lab) Pilot Plant Post: Executive – Sr. Executive Experience: 3 - 8 Years Education: B.E / B. Tech – Chemical Engineer Work Location: Halol, Vadodara Industry: Chemical / Agro Chemical / Specialty Chemicals Profile Responsibilities: Development of safe, scalable, cost-effective processes in the Kilo Lab / Pilot Plant. Support commissioning of processes at the commercial plant, developed in KL/PP. Troubleshooting existing processes as per business/production requirements. Experience working in KL/PP and scale-up teams. Handling various chemicals, preferably in the specialty chemical industry. Experience in batch & continuous process development in KL/PP. Strong technical knowledge of safety practices in process design. Basic engineering calculations – Utility, solvent recovery, mass balance, and energy balance. Preparation of block diagrams, PFDs, layouts, and equipment lists. Support design team with PFD, P&ID, equipment sizing, and MOC selection. Develop strategies to enhance productivity/yield or reduce cycle time and energy utilization.
Posted 1 month ago
9.0 - 12.0 years
8 - 15 Lacs
Vadodara
Work from Office
Company Name: Oneiro Lifecare Pvt Ltd Designation: Asst Manager/ Dy Manager Job Location: Ekalbara, Vadodara Role & responsibilities Lead and manage process development, scale-up, and technology transfer activities. Provide the Documents, P&ID, PDF, PDS, and Material & Energy Balance, costing sheet to New Products as well as Existing Products Optimize process parameters to improve yield, quality, and productivity. Troubleshoot process-related issues and ensure smooth production operations. Work closely with R&D, QA, QC, EHS, and production teams. Conduct risk assessments, HAZOP studies, and implement process safety measures. Support new product introductions and validation activities. Ensure compliance with cGMP, regulatory guidelines, and internal SOPs. Develop and maintain process documentation such as PFDs, P&IDs, batch records, etc. Identify and implement cost-saving initiatives and energy optimization. Train and mentor junior process engineers. Preferred candidate profile 10+ years of experience in Process Engineering in the Pharma / API industry . Strong knowledge of chemical unit operations and equipment (reactors, centrifuges, dryers, etc.). Hands-on experience in tech transfer , scale-up , and cGMP processes. Excellent analytical, problem-solving, and communication skills. Proficient in MS Office, AutoCAD, or other process simulation tools is an advantage. Should be familiar with safety and environmental regulations.
Posted 1 month ago
2.0 - 7.0 years
6 - 12 Lacs
Hyderabad
Work from Office
Formulation Chemist who can Turn wild ideas into real, shelf-ready formulas that make oral hygiene actually exciting. You will lead our R&D lab to create toothpaste thats viral-worthy, dentist-approved, and earth-kind from first sketch to factory, Annual bonus Food allowance Provident fund
Posted 1 month ago
7.0 - 12.0 years
8 - 15 Lacs
Jadcherla
Work from Office
We are looking for a meticulous and experienced Technology Transfer Manager to spearhead the efficient transfer of technology for solid dosage forms at Evertogen Life Sciences . This pivotal role involves overseeing the seamless transition of OSD products from R&D or third-party development to our manufacturing plant, ensuring successful scale-up, unwavering regulatory compliance, and adherence to the highest quality standards. The ideal candidate will champion the preparation and review of critical technical documents, including technology transfer protocols, BMR/BPR, and process validation reports, while actively coordinating with cross-functional teams such as QA, QC, RA, and Production. This role demands a proactive individual adept at troubleshooting technical challenges, participating in scale-up batches, and driving continuous improvement initiatives. If you are passionate about optimizing pharmaceutical manufacturing processes, possess a strong understanding of QbD principles, and thrive in a collaborative environment, we encourage you to bring your expertise to Evertogen and contribute to our mission of delivering high-quality, affordable medications to the global market. Your contributions will directly impact our ability to meet client needs and maintain a diverse product portfolio. Job Details: Industry : OSD Formulation (Pharmaceuticals) Department : Technical Transfer Role : Assistant Manager Tech Transfer Location : Jadcherla Compensation : Up to 15 LPA Experience : 8+ years Employment Type : Full-time Qualification : M.Pharm / B.Pharm / M.Sc. in Pharma or related field Responsibilities: Technology Transfer Execution & Documentation: Lead technology transfer projects for solid dosage forms, ensuring adherence to timelines and quality standards. Develop technology transfer protocols covering critical process parameters and quality attributes. Oversee preparation and review of essential documentation (Technology Transfer Plans, Gap Analysis Reports, Process Flow Diagrams, BMR, BPR, Process Validation Reports). Coordinate cross-functional activities (R&D, Manufacturing, QA, RA) for seamless transfer and scale-up. Monitor process performance, addressing deviations or challenges. Maintain detailed records of technology transfer activities, ensuring compliance and data integrity. Ensure documentation adheres to cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Manage document archival and retrieval. Process Validation & Scale-Up: Participate in process validation activities for robust manufacturing processes of OSD Formulations. Analyze process data to identify CPPs and CQAs for process control strategies. Troubleshoot technical issues during scale-up and validation, implementing corrective actions. Evaluate the impact of process changes on product quality. Collaborate with engineering and production to optimize manufacturing processes. Ensure compliance with validation lifecycle management. Quality & Regulatory Compliance: Ensure compliance with cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Conduct risk assessments and implement mitigation strategies. Participate in audits, addressing findings and implementing corrective actions. Maintain understanding of regulatory requirements and best practices in OSD Formulation. Oversee CAPA implementation. Promote a culture of quality and compliance. Technical Troubleshooting & Continuous Improvement: Lead troubleshooting during initial commercial batches, identifying root causes and solutions. Apply problem-solving methodologies to address technical challenges in OSD Formulation. Identify process improvement opportunities. Utilize SPC tools to monitor process performance. Implement Lean Six Sigma principles. Champion continuous improvement. Cross-Functional Collaboration & Stakeholder Management: Coordinate with QA, QC, RA, and Production teams. Facilitate communication and collaboration among teams. Manage stakeholder expectations. Build relationships with internal and external partners. Generate progress reports, highlighting milestones, challenges, and risks. Present technical data to teams and management. Lead meetings to discuss project status and make decisions. Act as a liaison between R&D, Manufacturing, and stakeholders. General Expectations and Past Experiences: Possess 8+ years of hands-on experience in technology transfer within OSD manufacturing, demonstrating a strong understanding of the entire process lifecycle. Demonstrate proficiency in preparing and reviewing critical technical documents such as technology transfer protocols, BMR/BPR, and process validation reports. Exhibit a thorough understanding of Quality by Design (QbD) principles and their application in pharmaceutical manufacturing. Showcase strong technical troubleshooting skills with the ability to identify and resolve issues during scale-up and commercial manufacturing. Proven ability to coordinate and collaborate effectively with cross-functional teams, including QA, QC, RA, and Production. Demonstrate a solid understanding of regulatory guidelines (US FDA, EU EMA) and CGMP compliance requirements for pharmaceutical manufacturing. Experience risk assessment methodologies and CAPA management systems in a pharmaceutical setting.
Posted 1 month ago
3.0 - 8.0 years
2 - 7 Lacs
Dahej
Work from Office
Role & responsibilities: To receive instructions from AM / Manager / GM. To plan the work as per instructions from department head. To track the daily exhibit / site shift product's trail, engineering, Exhibit & Validation (not limited to) batches manufacturing and monitor it's progress constantly. To organize, supervise and control the activities of Technology Transfer department. To co-ordinate and co-operate with various departments like Raw material store, Engineering, Quality Assurance, Administration, Information Technology, Operational Project, Quality Control, Production etc. for smooth functioning of Technology Transfer department. To check and update various documents and records, ensure production records filled online during batch manufacturing. To check and maintain housekeeping of the department. To enforce latest developments in GMP, SOP's etc. To observe and report to the seniors of Product / Material / Machine for their abnormal identified behaviour during production process. To counter check Raw Materials Dispensing and to recheck the material prior to their use in production processes. To ensure that the Quality, Health, Safety, Environment policy and procedures are followed. To prepare documents of New Product (ANDA) and site shift products (which includes CCF, MFC, BMR, QFR, ISP, PPQP, QRM, ESR TT Protocol, TT Report & PPQR (not limited to). To prepare documents for MES activity. To check, (i) Sampling request to Quality Assurance Department (ii) Material requirements requisitions (iii) Received batch from RM department To check / verify, (i) Daily Work in progress status. To achieve required production targets as per the budgetary norms. Handling of change parts. To ensure proper follow of company's rules and regulations. To ensure that all documents are complete in all respect prior to next stage of processing. To write requisition slips of Auxiliary Materials / Stationary materials etc. of daily use. To procure and control the utilization of such materials. To maintain optimum stock level of such materials for smooth functioning of department. To carry out any additional responsibility entrusted from time to time. Monitoring of Production process at each stage. To understand and follow all written procedure and manufacturing instructions mentioned in the respective batch record or any other quality document before starting production activity. To monitor constantly the CAPA of deviations, OOT and OOS to complete within time frame. To perform the investigation within timeframe related to quality system i.e. deviation, OOT and OOS. To be in communication with TRC and it's cross functional team for coordination and knowledge sharing of new site transfer products. To ensure that all SOP trainings are fulfilled on periodic basis. To coordinate activities like visit, document transfer and monitoring (but not limited to) related to manufacturing of products at CMO site. Preferred candidate profile: Candidates should have experience in Pharmaceutical background. Qualification: M. PHARM. Experience: 3 to 8 Years
Posted 1 month ago
4.0 - 6.0 years
8 - 12 Lacs
Kerala
Work from Office
Manage entire technology transfer from R&D to manufacturing. Lead pilot plant trials/scale-up protocols Work closely with Production/QA/EHS teams Conduct fit-gap assessments Monitor pilot batches/readiness for commercial launch Required Candidate profile 4+ yrs exp in tech transfer/pilot scale-up in API, in Pharma cos. Familiar with distillation/extraction/solvent recovery/filtration/drying system Expert in GMP/EHS practices
Posted 1 month ago
1.0 - 4.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Housekeeping of the R & D area and maintaining all apparatus related to experiment. Verification of weighing equipment. Validation experiment carried out on a related project. Manufacturing the products as per R&D trials. To develop the process as per ICH / pharmacopoeia quality. To optimize the finalized process and scale-up. To generate the negative and challenging data required to meet the scale up challenges. Verification batch and validation batches. Coordination with the ADL department. Coordinate work with lab peers. To maintain a lab notebook of all current projects. To check and review the calibration record of the instruments / equipment. To take safety awareness related to hazardous reactions. Give reporting to the department head as per timeline.
Posted 1 month ago
4.0 - 8.0 years
6 - 10 Lacs
Hyderabad
Work from Office
Role & responsibilities Job description Dosage forms experience: Solid Oral & Injectable experience in TTD/PDL/MS&T. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development in R&D and in Pilot/Manufacturing Site. Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments. Dedicate Experience in technology transfer of product(s) under development activities from scale up, exhibit batches. To lead and support the site transfer products from scale up to product launch. To prepare, review and hand-over the Technology Transfer Dossier to plant and communicating effectively to CFT team :- MFR, MPR, BMR, BPR, Preliminary Risk assessment (as per QbD) Risk Assessment of before going to Scaleup Risk Assessment of before going to Exhibit batches Scaleup Protocol & reports Scaleup Sampling and Exhibit batch sampling Plan Exhibit batch reports Control Strategy (Qbd) before Scaleup, Exhibit batches Risk assessment of CPP over CQAs and etc. And not limited to. To provide the technical inputs for initiation of Scale up batches. To provide the technical presentation on new product initiation to Cross functional team. To monitoring and execution of Scale up batches for site transfer products as well as in-house developed products. To co-ordinate with cross functional teams for smooth technology transfer. To review the exhibit batch documents, intended documents for filing purpose. Qualifications M.Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in technology transfer solid oral formulations and injectable products.
Posted 1 month ago
2.0 - 7.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Dear Respected All, Greeting from Biophore India pharmaceutical Pvt Ltd. (oral solution exp) We have opening for Formulation R&D Department. Position : Executive or Sr Executive 1)Candidate must have knowledge Prototype & Product Development. 2) Must have Literature Search. 3) Scale-up Batches, Exhibit Batches, DOE Experiments. 4) PDR Preparation & Development related documentation. 5) Experience in US ,EU Markets. 6) Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. Good Communication Skills Ref to Friends or colleagues Please share update resume: careers@biophore.com Total Exp : Current CTC: Exp CTC: Notice Period: Current Designation
Posted 1 month ago
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