14 Lcm Jobs nearby Mangalore

As a Senior Systems Specialist-Product Engineering LCM at Cytiva, you will leverage your engineering expertise to contribute to life sciences, diagnostics, and biotechnology with a shared commitment to innovation and tangible impact. Your role will involve various responsibilities and qualifications: Role Overview: You will apply multiple engineering disciplines to plan, organize, and conduct technical projects within the design, fabrication, modification, and evaluation of new or enhanced hardware products or systems at Cytiva. Your work will focus on life cycle management projects within the Bioprocessing Upstream systems. Key Responsibilities: - Formulate technical design concepts and establish system architecture for products, ensuring technical feasibility for life cycle management projects. - Design innovative solutions that meet all functional, performance, regulatory, reliability, and serviceability requirements for Bioprocessing Upstream systems. - Efficiently manage project life cycle from design to post-launch support/change management, adhering to internal project management methodologies. - Provide technical leadership, oversee engineering deliverables for yourself and the team, and ensure On-Time Delivery (OTD) and quality targets are met. - Focus on change management through Engineering Change Requests (ECR) and Engineering Change Orders (ECO), collaborating effectively with global cross-functional teams. - Hands-on working on the prototyping, testing, and verification of systems. Qualifications Required: - Possess a BE in Mechanical, Electrical and Electronics, or Instrumentation and Controls Engineering with 9-12 years of industrial experience in Engineering design for product life cycle management projects. - Experienced in handling ECRs and ECOs, comprehensive knowledge of Product Lifecycle Management (PLM) systems, and proficiency in design verification and testing. - Familiarity with project management practices and tools, technical expertise in specifying, selecting, and designing components, and experience in creating and modifying EBOM. - Strong analytical skills, expertise in technical problem-solving techniques, and in-depth understanding of various manufacturing processes. - Excellent presentation and communication skills, both verbal and written.,

As an Analytical Chemist, your role will involve developing analytical methods such as Routine Analysis using techniques like HPLC, GC, LCMS, KF, and FTIR. You will be responsible for maintaining analytical documentation including Protocols, specifications, etc. Additionally, you will be involved in the calibration of HPLC and GC instruments. It is essential to have knowledge about data integrity and ALCOA principles. You will also be working on Chiral method development. **Key Responsibilities:** - Performing Routine Analysis using HPLC, GC, LCMS, KF, and FTIR techniques - Maintaining analytical documentation including Protocols, specifications, etc. - Calibrating HPLC and GC instruments - Developing Chiral methods **Qualifications Required:** - Bachelor's degree in Chemistry or related field - Proven experience in analytical method development - Familiarity with data integrity principles and ALCOA guidelines,

As a LifeScience Regulatory Services Associate at Accenture, you will be part of the Life Sciences R&D vertical, contributing to regulatory services for leading biopharma companies. Your role will involve performing regulatory affairs LCM with Veeva skill set, submission in accordance with ICH guidelines, and reviewing and transforming source documents. Additionally, you will be responsible for performing Quality Control checks for all submission components, collecting and evaluating scientific data, advising on legal and scientific requirements, and ensuring compliance with current regulations. Key Responsibilities: - Perform regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities - Review and transform Source Documents - Perform Quality Control (Document QC) checks for all submission components - Collect, collate, and evaluate scientific data gathered as part of R & D - Advise on legal and scientific restraints and requirements - Ensure the organization`s products comply with current regulations - Build regulatory submission strategy, author CMC documents, and health authority packages Qualifications Required: - Master of Pharmacy In this role, you will be expected to solve routine problems with guidance from general guidelines, interact within your team and with your direct supervisor, and receive detailed instructions for daily tasks and new assignments. Your decisions will impact your own work within a predetermined scope as an individual contributor in a team setting. Please note that this role may require working in rotational shifts.,

As a Bioanalytical Scientist at our company, you will be responsible for: - Developing and validating bioanalytical methods using LCMS and other sophisticated instruments - Carrying out routine calibration of instruments - Demonstrating a thorough knowledge of LCMS, HPLC, HPTLC, GCMS, and other analytical instruments - Ensuring compliance with USFDA guidelines - Utilizing excellent communication skills to effectively coordinate with team members - Displaying good interpersonal and management skills - Holding strong basic knowledge of analytical instruments such as HPLC and LC-MS - Being accountable for group productivity, including the number of samples, analysis quality, quantity, and timelines, with a focus on improving Turn Around Time (TAT) Desirable Skills and Experience: - 2-5 years of experience in Bioanalytics Please note that the job is located in Manipal, India, and requires a Bachelor's Degree in Pharma. This is a Junior position in the Generics Development department, which is a full-time role.,

As a Biology expert, you will be responsible for the following key responsibilities: - Expertise in handling HPLC and LCMS, including troubleshooting techniques. - Proficiency in different extraction procedures and independent handling of bioanalysis for various matrices in PK and ADME studies. - Good understanding of various column chemistry and its application in method development. - Ensuring data integrity and maintaining good documentation practices, including recording data in LNB and completing studies as required. - Operating and maintaining laboratory equipment. - Ensuring all instruments are maintained in a calibrated status. - Managing consumables and chemicals necessary for the smooth conduction of PK studies without delays. Your required experience and skills include: - Master's degree with 6-10 years of experience in Pharmaceutical/Biotechnology/CRO industry in Bioanalysis, focusing on NCE, peptides, nucleosides, etc. - Solid knowledge and broad experience in Bioanalysis of various DMPK samples. - Familiarity with troubleshooting problems during Bioanalysis. - Excellent interpersonal skills and ability to work effectively in a team. - Proficiency in computer skills and a good understanding of statistics. - Demonstrating a strong sense of responsibility and work ethics.,

Role Overview: As a Global Labeling Team Manager, you will lead a team of Global Labeling colleagues based in India/Bangalore, driving the Global Regulatory Affairs (GRA) labeling mission. Your primary responsibility will be to guide the team on daily operations concerning Labeling Life Cycle Management (LCM) and to provide strategic labeling guidance for various projects. Key Responsibilities: - Oversee daily labeling operations and ensure compliance with pharmaceutical regulations and laws. - Act as the primary point of contact for internal stakeholders and facilitate cross-functional initiatives. - Build capabilities within the team and implement new methodologies to enhance onboarding processes and increase team capacity and agility. - Manage the performance of direct reports, including rewarding achievements, addressing complaints, and resolving issues. - Handle recruitment, resource allocation, workload management, and escalation resolutions. - Develop team development plans, offering opportunities for team members to enhance their skill sets. - Provide feedback on succession planning to align individual capabilities with organizational needs. - Champion and communicate the organizational vision and values, ensuring adherence to established work practices. - Prepare reports summarizing team activities, operational highlights, and progress as needed. Qualifications Required: - Experienced Professional: Over 12 years in the pharmaceutical industry, specializing in global labeling and regulatory affairs. - Expert in LCM: Strong background in Labeling Life Cycle Management (LCM) with a deep understanding of pharmaceutical regulations and compliance. - Effective Leader: Proven ability to manage and develop teams, guiding daily operations while fostering collaboration and continuous improvement. - Stakeholder Engagement: Skilled in building relationships with key stakeholders and driving cross-functional initiatives to enhance operational efficiency. - Talent Developer: Committed to nurturing team talent, providing opportunities for skill development, and aligning capabilities with organizational needs. Additional Company Details: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!,

As a Team Lead in Process Development at Dr. Reddys Laboratories Ltd., your primary responsibility will be to lead and guide the Injectable Process development team in areas of Quality by Design (QbD), Process selection, Scale Up, and Technology transfer to Manufacturing, Science & Technologies (MSAT)/ Formulation Technology Organisation (FTO)/ Contract Manufacturing Organisation (CMO). You will ensure that product development leads to the development of a robust manufacturing process throughout the clinical phases and commercial product life cycle. **Roles & Responsibilities:** - **Technology Transfer, Troubleshooting & Continuous Improvement** - Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM). - Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities. - Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers. - Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products. - Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments. - Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals. - Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving. - Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs). - **Cleaning Validation** - Prepare and review cleaning validation documents including protocols, reports, master plans, and assessments. - **Analytical Support** - Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance. - Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives. - **Subject Matter Expertise** - Serve as the subject matter expert for fill-finish processes, ensuring robust and compliant operations. - **Knowledge Sharing & Talent Development** - Facilitate knowledge sharing through discussions, training sessions, and invited talks to build analytical competence. - Support talent acquisition and induction processes to ensure recruitment of qualified personnel. **Qualifications:** - Educational qualification- Master in Pharma/ Ph.D in Pharma - Minimum work experience- 10-12 years of Experience and at least 6 years of experience in Drug product tech transfers & operations support (DP-MSAT) **Skills & Attributes:** - **Technical Skills** - Handled various forms of injectables which includes dry powders, lyo products, and liquid injections. - Knowledge of the technology transfers from site to site and R&D to operations. - Knowledge in Six Sigma Lean Techniques. - Knowledge about Good Documentation practices (GDP) and Good Manufacturing Practice (GMP). - **Behavioural Skills** - Excellent communication and interpersonal skills. - Strong analytical and problem-solving abilities. - Ability to work collaboratively with own team and cross-functional teams. In this role, you will have the opportunity to work in the Integrated Product Development Organisation at Dr. Reddys, where you will be contributing to the development of innovative, accessible, and affordable therapies for patients worldwide. You will be a part of a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions. At Dr. Reddys, we actively support your career growth and professional development through personalized learning programs. Our benefits are on par with the best industry standards and include joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself. Dr. Reddys believes in fostering a culture of empathy and dynamism, where individuals with diverse skills come together to make magic happen. Join us in our mission of ensuring that Good Health Cant Wait. Visit our career website at [Dr. Reddys Careers](https://careers.drreddys.com/#!/) for more details.,

As a Project Coordinator within our organization, you will be responsible for a variety of key tasks and activities to ensure the successful execution of projects. Your primary duties will include: - Creating and maintaining reports for KPI tracking, dashboard creation, and other PMO related data points. - Managing and overseeing smaller projects with a value below $100K, ensuring alignment with project objectives and stakeholder expectations. - Performing end-to-end Project LCM activities, including planning, execution, monitoring, and closure. - Tracking project deliverables, timelines, and budgets while proactively identifying and mitigating risks. - Coordinating with cross-functional teams to facilitate smooth project execution. - Preparing and maintaining project documentation, such as status reports, project plans, and risk assessments. - Ensuring compliance with project governance and quality standards. - Identifying process improvement opportunities and contributing to best practices. - Acting as the primary point of contact for stakeholders, ensuring clear and timely communication. - Facilitating project meetings and providing actionable insights for decision-making. - Supporting change management initiatives to align with evolving business needs. - Fostering collaborative working relationships within operations and across all levels and departments of the organization to execute project coordination activities and company priorities. - Achieving performance targets established by leadership for applicable Key Performance Indicators. - Performing any other duties as assigned by management. Qualifications: - Bachelor's degree in Business Administration, Project Management, Information Technology, or a related discipline. - Minimum of 4-6 years of relevant experience in project coordination or project management within IT/Infrastructure or related industries. - Proficiency in project management tools such as MS Project, Smartsheet, and ServiceNow. - Strong understanding of project planning, scheduling, and budgeting techniques. - Familiarity with project management methodologies like Agile, Waterfall, and hybrid models. - Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring the overall quality of delivery. - Strong analytical skills, including requirements documentation, troubleshooting, and creative problem-solving. - Experience in risk management and mitigation strategies. - Competence in preparing project reports and stakeholder presentations. - Working knowledge of procurement and vendor coordination processes. - Familiarity with financial tracking and cost control within project constraints. - Understanding of compliance and governance processes in project execution. - Excellent communication skills, both written and verbal, customized for the U.S. market. - Proficient in MS Office (Word, PowerPoint), Outlook, SharePoint, etc. - Highly skilled in Microsoft Excel.,

As a Chemist, your role involves performing standard chemical and physical analysis of inner and outer nutritional products in the quality control lab using wet chemistry techniques and instrumental analyses. You will contribute by conducting laboratory testing, preparing standards and reagents, calibrating and operating sophisticated laboratory instrumentation, reviewing product certificates of analysis, maintaining Certificates of Analysis (C of A) files, and providing input on Standard Operating Procedures (SOPs), Test Methods, and laboratory documents. Additionally, you will participate in investigations, address Out of Specifications (OOS), resolve deviations, and implement Corrective and Preventive Actions (CAPA) with general supervision while strictly adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Key responsibilities: - Interpreting test results - Maintaining a safe, clean, and efficient laboratory environment - Ensuring routine calibration and performance verification of lab equipment and instrumentation Although there are no supervisory responsibilities, you should possess the ability to adapt as the external environment and organization evolve. Successful candidates will demonstrate the ability to complete testing according to established methods, proficiency in lab instrumentation and multiple test methods, problem-solving skills, and the capacity to coordinate workload effectively. Qualifications required: - Bachelor/Master of Science in Chemistry, Biochemistry, or related scientific fields, or equivalent experience - Knowledge of LC/MS and GC/MS - Previous cGMP regulation and compliance knowledge - Nutraceutical or pharmaceutical laboratory work experience - Familiarity with ISO17025 Lab Management Join us in this exceptional opportunity to contribute to world-class research and shape the future of nutritional science.,

As a Sr Technical Specialist at Philips, you will be responsible for developing the Philips API, Microservices, and FrontEnd applications to expose and orchestrate functionality of various services, both internal and from 3rd party software. You will actively participate in implementing the platform approach across central horizontal teams and function-specific vertical teams. Collaboration with vertical teams in the development and Lifecycle Management (LCM) of services is also a key aspect of your role. Key Responsibilities: - Develop microservices adopting a managed API way of working targeting cloud deployments - Create FrontEnd Applications using React/Angular - Develop services using SOA/Rest/Micro Service patterns and programming languages like Java, Python, Go, NodeJS - Design APIs and common services within a given domain - Utilize cloud technologies from public cloud providers and associated middleware - Work with Open API Specification and API documentation tools such as Swagger and Postman Qualifications Required: - Bachelor's degree in engineering (computer science or equivalent) with 10+ years of experience - Expertise in creating microservices and FrontEnd Applications - Proficiency in SOA/Rest/Micro Service patterns and programming languages - Experience in designing APIs and services within a domain - Familiarity with cloud technologies and associated middleware - Knowledge of Open API Specification and API documentation tools As part of a geographically distributed team, you should have a global mindset and the ability to collaborate with teams across different time zones. You should excel at designing and writing meaningful tests, possess excellent communication skills, and be a team player working with cross-functional teams. Having an appreciation for multiple domains within healthcare and wellness, along with sensitivity to cultural differences in globally spread teams, is essential for success in this role. Please note that for office-based roles, in-person work is required at least 3 days per week. Onsite roles necessitate full-time presence at the company's facilities, while field roles are primarily conducted at customers" or suppliers" locations. If you are interested in making a difference in healthcare technology and have most of the required experiences, we encourage you to apply for this role at Philips. Learn more about our company's commitment to improving healthcare access for everyone and our rich history by visiting our website.,

You will be responsible for: - Preparing, reviewing, and approving technical protocols, reports, and product impact assessments related to product lifecycle management (LCM) - Initiating change controls, incidents, and risk assessments related to technology transfer activities - Supporting technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products - Coordinating with cross-functional teams for execution and documentation of new products, scale-ups, and line or site transfers - Supporting investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments - Providing technical support for process changes and improvements along with addressing regulatory deficiencies and supporting audits to ensure timely product approvals - Collaborating with cross-functional teams to improve manufacturing processes - Conducting data analysis to identify trends and opportunities for process improvement - Assisting in the implementation of process improvements and new technologies - Ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements Qualifications: - Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy About the Department: Integrated Product Development Organisation The Integrated Product Development Organisation at Dr. Reddys integrates deep science capabilities and cutting-edge technology to develop innovative, accessible, and affordable therapies for patients worldwide. They are committed to accelerating access to healthcare solutions globally, with capabilities in API, Formulations, Clinical, Intellectual Property, and Regulatory Affairs. Serving 55+ markets, their product development efforts drive a portfolio of more than 1,000 products. Benefits Offered: Dr. Reddys actively supports your career growth and professional development through personalised learning programs. The benefits include joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself. Work Culture: At Dr. Reddys, the core guiding principle is "Good Health Cant Wait". They see healthcare solutions as a means to help patients lead healthier lives and foster a culture of empathy and dynamism. With a focus on individual ability, teamwork, and shared success, Dr. Reddys believes in empowering people to stay fit.,

You will be responsible for overseeing the Program and Project Management of External Manufacturing at Biocon Biologics. This includes participating in business case preparations and approvals, preparing project charters, and managing technology transfers. You will be expected to have a high-level understanding of Supply Network Management and ensure the successful delivery of projects on time and within the approved budget. Key Responsibilities: - Follow the Governance Structure and Escalation Matrix defined within the Global Program Management function - Finalize project scope and plans, track Plan Vs Actual, and proactively build scenarios for impact mitigation - Monitor project progress using scheduling tools such as MSP and Office timeline - Coordinate with cross-functional teams for program deliverables, manage communications, escalations, and problem-solving - Plan the program budget on an annual, quarterly, and monthly basis, forecast budgets for Development programs, and liaise with various teams to finalize budget forecasts for the fiscal year - Ensure data package readiness for dossier submissions, liaise with Regulatory Affairs team for LCM Programs, and coordinate with cross-functional teams for timely response submissions to agency queries - Facilitate the plan and data readiness for scientific advice/feedback from regulatory agencies - Ensure readiness of Confidentiality Disclosure Agreements (CDA), Master Service Agreements (MSA), and Statements of Work (SOW) before engaging with external vendors and CROs - Liaise with Procurement and Logistics teams to facilitate and track shipments of project-related materials, test items/drugs, and testing/biological samples - Ensure availability of project-related consumables, equipment, and critical reagents required for the program - Develop systems and processes to enhance operational efficiency, provide MIS and Management reporting, promote project management practices among Cross-Functional Teams (CFTs), and identify business-enhancing opportunities that can be proposed as projects Qualifications Required: - Bachelor's degree in a relevant field, such as Project Management or Supply Chain Management - Strong understanding of Program and Project Management principles - Excellent communication and stakeholder management skills - Ability to work effectively in cross-functional teams - Prior experience in External Manufacturing or related fields is preferred (Note: No additional details of the company were included in the provided job description),

As a Program and Project Manager at Biocon Biologics, you will be responsible for the development programs related to biosimilars. Your key responsibilities will include: - Developing business cases, preparing project charters, and managing project schedules - Tracking project execution, budget commitments, and spends to ensure successful delivery on-time and within approved budget - Following the Governance Structure and Escalation Matrix defined within the Global Program Management function You will also be responsible for scope and schedule management by finalizing project scope and plan, tracking plan vs actual, and proactively building scenarios for impact mitigation. Monitoring the progress throughout the project lifecycle using scheduling tools like MSP and Office timeline will be crucial. Stakeholder management will be a key aspect of your role, involving coordination with cross-functional teams for program deliverables, managing communications, escalation, and problem-solving to ensure project deliverables stay on track. In terms of budget management, you will plan the program budget (Annual/Quarterly/Monthly), forecast budgets for Development programs, liaise with Finance, R&D, Regulatory, Clinical & Ops teams, and monitor/control project progression to ensure on-time and within budget completion. Your responsibilities will also include regulatory tasks such as ensuring data package readiness for dossier submissions, liaising with RA team for LCM Program, and facilitating plan and data readiness for scientific advice/feedback from regulatory agencies. Additionally, you will work closely with the Legal team to ensure readiness of CDA, MSA, SOW before engaging with external vendors and CROs. Liaising with Procurement and Logistics teams for shipments, procurement of project-related items, and managing technology transfers to third-party service providers or in-house facilities will also be part of your role. As part of the PMO responsibilities, you will develop systems and processes to enhance operational efficiency, handle MIS and management reporting, promote project management ways of working among CFTs, and identify business-enhancing opportunities that can be proposed as projects. The ideal candidate for this role should have 5 to 10 years of overall experience, with a preference for biosimilar experience.,

Role Overview: As a Software Engineer II, Backend at Skit.ai, you will play a crucial role in designing and developing highly available, reliable, secure, and fault-tolerant systems. You will be responsible for managing multiple services, improving product reliability, and contributing to engineering efforts to solve complex problems. Additionally, you will be expected to provide technical support to address incidents and escalations efficiently. Key Responsibilities: - Design and develop highly available, reliable, secure, and fault-tolerant systems. - Take responsibility for multiple services and collaborate with Tech stakeholders to improve product reliability. - Contribute to engineering efforts from planning to execution and delivery to solve complex problems. - Manage individual priorities, deadlines, and deliverables effectively. - Provide Level 2 technical support to address incidents and escalations. Qualifications Required: - Bachelor's degree in Engineering. - Proven ability to design, develop, and manage microservices at scale. - Proficiency in handling incidents and escalations of complex technical issues. - Willingness to collaborate across team boundaries and work with different roles. - Eagerness to learn and experiment with new languages and technologies. About Skit.ai: Skit.ai is the pioneer Conversational AI company that is revolutionizing collections with omnichannel GenAI-powered assistants. Their Collection Orchestration Platform streamlines collection conversations by syncing channels and accounts, while their Large Collection Model (LCM) powers the strategy engine to optimize interactions and enhance customer experiences. Skit.ai has received prestigious awards and recognitions, including the BIG AI Excellence Award 2024 and the Stevie Gold Winner 2023 for Most Innovative Company. Headquartered in New York City, NY, Skit.ai is dedicated to driving innovation in the AI space. Note: This is a requirement for one of Uplers" clients - Skit.ai. Uplers aims to simplify the hiring process and support talents in finding relevant opportunities to progress in their career. Apply today for a chance to join a dynamic work environment and take your career to the next level!,