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10.0 - 15.0 years
35 - 40 Lacs
bengaluru
Work from Office
Role-specific: Preparation, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Record (PDR). Issue, Checking and Review of Operations documents. Preparation and review of Batch Manufacturing Records, SOPs, PDRs & Protocols. Conduct training for all DSP employees for prepared BMRs, PDRs and related documents. Review of TTD s, protocol and Quality Department Protocols related to Operations. Investigation of Batch failures in Operations. Monitor and follow good aseptic behavior inside BMP5 DSP Facility. Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals. Update the batch progress in PRM s and participate in client discussions. Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Liaise with regulatory affairs to ensure compliance with industry standards and guidelines. Ensure that all DSP processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements. Develop and implement strategic plans to achieve project milestones and goals. Mentor and develop team members to foster a high-performance culture. Education Master s degree/ bachelor s degree in pharmacy, master s degree in Pharmaceutical Sciences. Industry Experience Minimum 10 -15 years of relevant practical experience in mAbs Downstream process and documentation. Other competencies required for the role Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment. Experience with automation and data analysis tools applied for cell culture bioprocessing. Familiarity with regulatory submissions and quality systems in the biopharmaceutical industry. Strong interpersonal skills with ability to work with internal and external stakeholders. Excellent written and verbal communication skills for regulatory documentation and presentations. Strong knowledge of bioprocessing principles, cell culture techniques, and scale-up methodologies. Perform review of protocols (study protocols, equipment qualification protocols etc. ). Review the executed protocols and provide adequate support for timely closure of the same Preparation of general DSP related procedures, protocols, risk assessment and BMRs. On-time initiation & closure of deviations, investigations, CAPA and change controls. Safety and DI Responsibilities: Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security. Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety. Understand all necessary safety protocols and always follow the same to ensure safety for all. Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals.
Posted Date not available
6.0 - 9.0 years
8 - 11 Lacs
ahmedabad
Work from Office
The BP Cell Culture Sales Specialist will report to the BP Cell Culture India Leader and is part of the Cytiva India Commercial organization located in Ahmedabad will be working remotely to cover the assigned region . At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. What you will do: Provide pre and post sales technical support to customers and sales teams on cell culture related product lines (Cell Culture Media and feeds, Process Liquids and Buffers, Serum, Custom services, Bioreactor and Microcarriers) Plan and achieve target assign (Order /sales/ Design in) Based on effective root cause analysis provide technical solution and troubleshooting the process to achieve customer goals. Design-In of cell culture products in customer process and achieve higher market share in the region Develop good long-term customer relationships, and high customer satisfaction utilizing optimum level resources. Collect customer and market feedback from the field and channel it to internal team and relevant departments Ensure exhaustive reporting of all on-field activities and customer contacts on SFDC. Maintain record of sampling. Conduct product/technical training programs for internal and external customers Who you are: Master s degree in biotechnology, Engineering degree in biotechnology or biochemical engineering 6-9 years of hand on experience in Biopharmaceutical industry in upstream process development (Mammalian). Proven skills in handling various cell lines/lineages, process optimization and CQA modulation Hand on experience in concentrated fed batch/perfusion process development is an added advantage Proficient in basic cell culture techniques and stable cell line development
Posted Date not available
3.0 - 8.0 years
5 - 10 Lacs
bengaluru
Work from Office
Development of regional breast cancer patient cohort stratification platform and novel therapeutic strategies by leveraging NSMCE2 E3 SUMO enzyme deficiency and chemotherapeutic drug sensitivity: Insights from Indian clinical samples and cellular model studies Eligibility Masters degree in Biomedical Science/ Biotechnology/ Microbiology/ Molecular Biology/ Biochemistry/ Any branch of Life Science with at least 55% marks Desirable qualification Prior experience in cell and molecular biology techniques including cell culture, Western blotting, cloning, FACS, patient sample handling, tissue histopathology will be preferred Duration The project is for 3 years. Yearly extension is based on annual review of the performance. The position is co-terminus with the project.
Posted Date not available
2.0 - 5.0 years
6 Lacs
bengaluru
Work from Office
JOB DESCRIPTION Designation: Senior Research Associate (9-II) Job Location: Bangalore Department: Pathology / IHC About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation . Job Purpose (1-2 Lines): This is a lab-based position for histopathology/ IHC, and the major p urpose is clinical biomarker assay development, validation, and analysis. Key Responsibilities: Undergo training, handle and perform independently, routine histopathology techniques including sectioning, embedding, grossing and H&E staining. Undergo training and perform monoplex chromogenic automated IHC assays, with 100% compliance to internal standardization guidelines Undergo training on handling all automated equipments, starting from autostainers, coverslippers to digital scanners. Use these equipments as directed in Work instructions. Scan slides fluently using Digital slide scanners, label and maintain whole slide Image repository. Perform and support cell culture techniques independently. Document & maintain appropriate records of all lab related processes Reagent Inventory & Slides/Block Management, including but not limited to tracking inflow of commercial blocks/slides, reblocking if required, maintaining an inventory with details of consumption of blocks/slides, uploading on Image repository platform with proper labelling, tracking expiry of reagents etc. Actively participate in SOP preparation and periodic review. Document and maintain appropriate records Perform other lab duties as instructed. Educational Qualification and Experience M.Sc/M.Tech in Biology/Biotechnology/ Biochemistry or equivalent with 2-5 years of relevant experience in histopathology/IHC, working in research settings, academia, and corporate (Hospitals/Pharma). Technical/functional Skills: (Maximum 4-6 Points) Experience in performing routine histopathological techniques is required . Previous knowledge and experience in biomarker assay development and validation is preferred Previous molecular pathology laboratory management skills desired. Behavioral Skills: Good communication and analytical skills Enthusiasm to learn quickly with minimal training Should be meticulous at the documentation and capable of multitasking Team player and able to adjust in a fast pace work environment Equal Opportunity Employer: .
Posted Date not available
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