Ocugen, Inc. is a biopharmaceutical company focused on developing innovative therapies to treat eye diseases and other conditions. They are also involved in the development of COVID-19 vaccine candidates.
Hyderabad
INR 15.0 - 25.0 Lacs P.A.
Work from Office
Full Time
Job purpose The Sr Manager/Associate Director, Program Management will partner with the Cross functional team (CFT)to lead the Development Program Team (DPT) to successfully execute the project and drug development strategies, as well as lifecycle plan. The Project Manager is accountable for integrated development plans including management of timelines, cost, quality, and risk mitigation by closely working with the CFT. The Project Manager provides an independent voice to shape the project strategy and drive optimal decisions for the broader portfolio value. This position can be assigned to any therapeutic area and work on projects at any stage of development. This is an onsite role. Duties and responsibilities The Sr. /AD - Project Manager is accountable for one or more DPTs of moderate complexity and is highly autonomous in their day-to-day work. The Project Manager may serve as part of a PM team supporting a large, highly complex DPT with oversight of a Senior PM. Partners with the Development Program Lead (DPL) to foster a high performing team and monitor the health and operating efficiency of the team as a unit Leads creation of team norms and operating principles with a focus on cross-functional input and accountability, and robust analysis of vetted options Acts as an integrator within the Development Program Team (DPT) and across the enterprise to ensure alignment and connect best practices Facilitates effective, science-based business decisions including development of scenarios as needed. Ensures all decisions are assessed as to their impacts and communicated to stakeholders in a transparent and timely manner Highlights interdependencies and downstream impacts of strategic decisions Proactively identifies risks and ensures mitigation plans are implemented Develops and coordinates resource planning across DPT to assure adequate resources are applied to the project Advise on governance expectations with focus on cross-functional input and rigorous debate For projects that are being jointly developed, works closely with a key strategic alliance partner Identify and mitigate project risks during the various phases of development of Drug and communicate risks to relevant stakeholders Collaborate with external CDMO, CRO, to define project timelines, establish and monitor KPIs, and manage relationship Define budget and resource needs, create work breakdown structures, set and track deliverables, perform critical path analysis. Ensure program communication and report program status to program team and Senior Leadership on regular basis. Recommend and implement best practices across program teams e.g., resource capacity planning, program risk management, team performance, timeline development, portfolio management. Well versed with developing dashboards for various projects depending on the Sr. Management requirement. Work with functional leaders to ensure positive team spirit and high functioning team. Prepare monthly progress reports and ad hoc reports as required. Participates in the development of Program Management tools, templates and processes. Additional tasks and projects as requested. Qualifications Ph.D. degree in a science discipline in a relevant scientific field with 15 years is required 5-10 years of relevant pharmaceutical industry experience, with at least 5 years managing cross-functional project teams Breadth of drug development expertise with solid understanding of project strategy and disease content to contribute to strategic discussions Experience in pharmaceutical drug discovery and development Knowledge of Drug development, manufacturing, Regulatory and clinical Possesses knowledge of all phases of the drug development cycle and has technical understanding toward the successful development and registration of pharmaceutical products Fully trained in all relevant PM processes and can competently use and employ essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution Ability to resolve complex problems and manage difficult stakeholder situations Ability to lead the development of critical path analyses and support scenario planning Excellent Project Management Skills drives execution while balancing speed, quality, and cost. PMP certification desirable Demonstrated ability to think strategically, work effectively in a matrixed environment, and execute multiple projects simultaneously Advanced working knowledge of Microsoft Project or Smartsheets, Excel, OneNote, and PowerPoint High level of personal integrity and strong conflict resolution and consensus building skills Ability to work effectively with cross-functional teams Flexible to work longer times depending on the requirement. Working conditions Incumbent will primarily work Monday Friday during normal business hours in an office environment. Travel up to 10% may be required. Physical requirements This is a largely sedentary role. Direct reports None
Hyderabad
INR 5.0 - 10.0 Lacs P.A.
Work from Office
Full Time
Job Purpose As part of the Ocugen team, the Computer Vision and Image Analysis Engineer will develop and manage systems for Ocugen that enable computers to process and interpret visual data, much like how humans perceive the world through sight. The ideal candidate should bring experience working in wide range of responsibilities, all centered around developing and optimizing systems that enable machines to interpret visual data. The candidate should also be experienced as a technical specialist for Image Analysis and Machine Learning projects. This position is located in Hyderabad, Telangana, India. Duties And Responsibilities Accountable to design and implement systems that allow computers to understand and analyze visual data in a manner similar to human vision to meet Ocugen business needs with a focus on regulated functions: Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders. Participate in the development of solutions and manage project/change timelines. Integrate visual models into real-world applications, ensuring that machines can interpret and react to their environment accurately and efficiently. Creating and fine-tuning algorithms that enable machines to interpret visual data and make decisions based on their sight is a core aspect of a Computer Vision Engineers work. Liaise with computer system vendors, Quality, and the business to coordinate implementation activities. Work with the business to develop system and user requirements. Define and oversee documentation of user manuals, configuration and design specifications. Perform rigorous testing and validation under different conditions to ensure the models perform well in real-world scenarios. Applying advanced techniques in image processing and deep learning to tasks such as image recognition, object detection, segmentation, and pattern recognition . Designing algorithms that can perform tasks like Image Recognition and Object detection. Deep understanding of machine learning techniques and problem-solving skills to create models that can accurately process and understand complex visual information. Implement techniques to process and analyze images and videos. This involves tasks such as Enhancing Image Quality, Image Denoising, Extracting meaningful information from raw visual data. Should have a solid grasp of image processing algorithms and the ability to apply them to real-world scenarios. Training machine learning models to classify and recognize visual data. Working with large datasets to develop models that can differentiate between various objects or patterns. Optimizing Code to reduce latency and ensure smooth operation. For e.g. Optimizing code to process video streams in real-time for security cameras, allowing quicker and more accurate threat detection. Staying up-to-update with the latest computer vision and artificial intelligence advancements is crucial. This involves reading research papers, experimenting with new techniques and implementing state-of-the-art methods. Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and organizational growth. Qualifications : Masters degree in computer science or technology with at least 5+ years direct experience working with Image Analysis and Machine Learning enduring Governance to drive strategic Product Roadmap Deliveries. Focus on mastering languages like Python, C++, and Java, as they are fundamental in computer vision projects. Python libraries like OpenCV and frameworks like TensorFlow & PyTorch are especially important for building and deploying models. Apply your knowledge by building projects, such as creating a facial recognition system using open-source datasets. Practical experience is invaluable. Experience and knowledge of quality and regulatory business processes. Direct hands-on experience implementing GxP computerized systems and maintaining validated state. Strong process improvement skills and orientation. Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment. Proven strong communication skills in interacting with users and technical communities. Ability to communicate ideas in both technical and user-friendly language. Collaborative working approach. Computer Skills: Experience in Machine Learning, Python, C++, and Java. Experience with Other Regulated Applications would be an asset. Computer networking knowledge. Experience working on SaaS (Software as a Service) systems. Working conditions This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements This is a largely sedentary role. Direct Reports None
Hyderabad
INR 8.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Job Purpose As part of the Ocugen team, the Preclinical Science and Innovation/Pharmacologist/Toxicologist will involve in planning and monitoring preclinical studies to ensure they are conducted efficiently, accurately, and in compliance with regulatory standards. You will collaborate closely with cross-functional teams to drive study progress, address challenges, and achieve project objectives. The ideal candidate should have expert level experience in drug discovery toxicology. He or she will help direct the design and management of pre-clinical toxicology studies and other safety studies as well as IND enabling activities. We are seeking toxicologists with strong research background in leading toxicology studies who are career-driven, have strong leadership skills, and a depth of experience in working on collaborative research teams. This position is located in Hyderabad, Telangana, India. Duties And Responsibilities: The incumbent is responsible for the liaison and coordination as well as providing scientific support to internal and external partners in terms of international preclinical projects management, including follow-ups. The incumbent also has to ensure that related timelines and budgets are met, activities are properly executed, and adequate resources are allocated. Typical roles and responsibilities for Toxicologist are, Conduct product safety and health risk assessments on the range of products and components through all phases of IND development Work on multi-functional teams and serve as primary toxicology liaison Gather information and provide guidance to project teams regarding all testing standards Provide strategic and hands-on management, ensuring toxicology studies are conducted in line with appropriate regulatory guidelines and standards, these include FDA, WHO, GLP, & ISO Initiate and manage contracts in conjunction with finance group and coordinate activities with academic collaborators for preclinical development in the areas of toxicology, pharmacology, and pharmacokinetics Lead or manage the design, monitoring and interpretation of In Vitro, In Vivo or pre-clinical safety studies conducted under Good Laboratory Practices (GLP) Author or present relevant toxicology information in appropriate journals or at conferences Provide input into safety-related statements and other documentation for use with the public and the media Gather needed information and identify areas of improvement, and provide needed training Participate on cross-departmental teams to contribute to the development or revision of departmental policies and procedures. Key responsibilities: Serves as a recognized toxicology expert and provides scientific and technical leadership to address toxicology issues and support US development programs. Collaborate with HQ to prepare the toxicology part of responses to inquiries from regulatory agencies (Investigator's Brochure, non-clinical assessment sections of INDs, CTAs, and NDAs, etc.). Planning and managing preclinical projects for different programs Act as the project team representative for toxicology on multidisciplinary project teams. Be the interface with toxicology with HQ, health authorities, and the toxicology community to expand our companys local presence and influence in the field. Highly organized individual to manage multiple projects, and work within cross-functional team. Plan and anticipate upcoming difficulties in plan execution, prepare contingency plans and strategies to overcome these difficulties. Qualifications: PhD in toxicology, pharmacology, or a related biological science with 5+ years of experience, or master's degree with 7 years of experience in the biotech/pharmaceutical industry. Understanding of current existing guidelines, regulations, requirements, and standards (GLP, ISO, OECD, ICH, etc). Proven ability to communicate well within a multifunctional drug development team, with excellent oral and written communication skills. The ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. The ability to proactively develop connections within the organization and with the external scientific community and utilize these resources in the resolution of issues. Experience managing complex pre-clinical studies in accordance with pertinent regulatory requirements. A record of accomplishment managing multiple pre-clinical studies concurrently. Strong project management skills and experience managing complex timelines for clinical studies Experience with clinical and nonclinical programs in biotechnology and pharmaceutical industries Strong analytical skills including interpretation of biologics, vaccines including preclinical and clinical samples Good knowledge of Word, Excel, Power Point, Outlook and Teams; Knowledge of MS Project or Smartsheet considered as an important asset. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies Working conditions: This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements: This is a largely sedentary role. Direct Reports NA
Hyderabad
INR 7.0 - 17.0 Lacs P.A.
Work from Office
Full Time
Job purpose The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested.
Hyderabad
INR 10.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Description As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose The Principal Biostatistician will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above. Expertise: Familiarity with statistical principles, CDISC data, and standards. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.
Hyderabad
INR 12.0 - 18.0 Lacs P.A.
Work from Office
Full Time
Job purpose The Manager/ Sr. Manager of Pharmacovigilance will navigate the complex landscape of clinical safety, on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports directly to the Chief Medical Officer at Ocugen. Duties and responsibilities As the Manager/ Sr. Manager of Pharmacovigilance, Clinical Quality, Safety and Pharmacovigilance, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance. The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugens clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these. The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients, and the general public. Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs. Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety. Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function. Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies. Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen’s studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions. Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities: Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. Provides input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Eight(8) to Thirteen (13) years pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management. Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. e.g. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing, and verbal communication skills. Ability to convey complex concepts through clear and concise messages. Excellent problem-solving skills, contingency planning, and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment. Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.
Hyderabad
INR 10.0 - 16.0 Lacs P.A.
Work from Office
Full Time
The Pharmacovigilance Lead will provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports AD, Clinical Development and Pharmacovigilance. Duties and responsibilities As the Pharmacovigilance Lead, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugen's clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen's studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives Interfaces with key high-level internal and external stakeholders, contributes to, and approves regulatory reports/submissions/queries. He/she independently addresses complex safety issues as a key decision-maker Provides strategic input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Degree in Medicine (MBBS, MD, Pharm D or equivalent) is required. Eight(3-8) years of pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. Eg. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing and verbal communication skills Ability to convey complex concepts through clear and concise messages Excellent problem solving skills, contingency planning and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.
Hyderabad
INR 10.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Job purpose The ideal candidate will be responsible for compiling, managing, and maintaining critical documents and data related to batch records, assay records, and other essential documentation in a highly regulated environment. This role is crucial for ensuring the accurate tracking, trending, and compliance of data. Duties and responsibilities Compile Data from Batch Records: Collect and organize information from batch production records, ensuring all relevant data is accurately recorded and easily accessible. Ensure batch records are compliant with Good Manufacturing Practice (GMP) standards and relevant regulatory guidelines. Compile and Review Assay Records: Gather and manage assay data, ensuring it is consistently and accurately recorded. Collaborate with laboratory teams to ensure timely and correct documentation of assay results. Data Tracking and Trending: Monitor and track production and assay data over time to identify any variations, trends, or issues. Develop and maintain data tracking systems to ensure that trends and variations are documented, evaluated, and reported effectively. Prepare and present regular trend analysis reports to management and other stakeholders. Document Control: Maintain a system of organized, up-to-date documentation related to batch and assay records, ensuring compliance with all regulatory requirements. Review and approve documents for accuracy, completeness, and consistency in line with established protocols and SOPs (Standard Operating Procedures). Compliance & Quality Assurance: Ensure all documentation adheres to regulatory requirements such as FDA, EMA, ICH, and GMP guidelines. Participate in internal audits, inspections, and document reviews to ensure compliance with industry standards. Qualifications • Master degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or related field. • 5+ years of experience in document management or quality control within the biopharma. • Strong knowledge of GMP, GLP (Good Laboratory Practice), and relevant industry regulations. • Experience in compiling and managing batch records, assay records, and production data. • Proficiency in Microsoft Office Suite and document management systems (e.g., Veeva Vault). • Excellent organizational skills with a keen attention to detail. • Ability to manage multiple priorities in a fast-paced environment. • Strong analytical skills and experience with data trending and report generation.
Hyderabad
INR 12.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality standards for products or services. Author or review Ocugen quality standards, procedures, and work instructions. Participate in cross - functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers. Build strategic relationships with CDMOs (Contract Development and Manufacturing Organization) within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed, and escalated, as necessary. Establish, maintain , and monitor supplier files including Quality Agreements with CDMOs and directly related suppliers to the CDMOs. Responsible for the quality review and approval of master batch records, executed batch records, reports, protocols, analytical methods, change controls, investigations, OOS (Out of Specifications), OOT (Out of Trends), deviations, and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities. Support RCA (Root Cause Analysis and associated tools) and product impact assessments for investigations resulting from deviations and OOS events. Oversee, review, and approve quality testing processes and identify gaps in testing. Oversee, review, and approve manufacturing processes and identify gaps in manufacturing. Overseeing, reviewing, and approving quality events and ensuring effectiveness is part of business improvements. Staying up to date with relevant laws and regulations to ensure compliance. Train other employees in quality standards and procedures and handle quality reports, documentation, and records. Collect and analyze QA data and prepare monthly and quarterly metrics regularly. Work with GMP vendors to ensure their quality and conduct vendor audit if necessary. Participate in internal audit program and followup on CAPA (Corrective and Preventive Actions) assigned to closure within the timeframe. Eliminating products that are not up to standards and finding the reasons for product problems Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives. Qualifications: Bachelor' or Masters in Biology, Chemistry, or related fields. At least eight (8) years for BS and five (5) years for MS GMP experience with a focus on quality with substantial operational and GMP experience supporting Biologics/Vaccines/Cell and gene therapy products. At least five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; at least two (2) years managing Phase 1-3 clinical trials. Prior experience and a broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge of the international regulatory landscape is preferred. In-depth knowledge of and ability to interpret and apply GMP EU, FDA (Food and Drug Administration), USP (United States Pharmacopeia), Phr. Eu., WHO, PMDA, and ICH regulations and guidelines. Excellent written, verbal, listening, and interpersonal communication skills. Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants, and contractors). Integrated Quality leader who can build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. Proven background in GxP and GMP audit management, risk management, mitigation, and controls. Proficient in Veeva Vault systems (QualityDocs, Training, eQMS, RIM, etc.). Working conditions This position operates primarily in an office setting and may include 10% of travel. This position is in Hyderabad, INDIA (on-site). This position will work in US business hours. Physical requirements This is a sedentary role.
Hyderabad
INR 4.0 - 5.0 Lacs P.A.
Work from Office
Full Time
Job purpose : The Admin Assistant will be responsible for playing a crucial role in ensuring the smooth functioning of the office. He will be responsible for providing essential support to the office staff and maintaining a clean and organized workspace. Duties and responsibilities: Provide front-desk coverage by managing a busy, multiline phone system, greeting guests as they enter the office, managing incoming/outgoing mail and shipments, and maintaining an organized, clean office environment. Provide administrative support to senior leaders, including email correspondence and generation and distribution of memos, letters, spreadsheets, forms, and faxes Plan, organize, and schedule company meetings in the office, off-site, and via videoconference Coordinate domestic and international travel arrangements for employees Order and oversee office supplies and food deliveries for group meetings Organizing and maintaining physical and electronic files, creating filing systems, and managing databases. Scheduling and coordinating team meetings and events, preparing agendas, and taking meeting minutes. Assisting with bookkeeping, expense reporting, invoicing, and basic accounting tasks. Ordering and managing office supplies. To Ensuring the cleanliness and tidiness of all office areas. Facilitating and booking the meeting rooms. Maintain inwards and outwards register Reporting any maintenance or repair issues of AHU, Electricals and office equipment. Assisting in the coordination of office events and functions. Assisting Finance, IT & HR to perform their daily operations. Qualifications & Skills : Proven experience as an Administrative Assistant or Office Admin Assistant Bachelors degree Computer skills English written and verbal communication skills Strong time-management skills and multitasking ability Aptitude for learning new software and systems Working conditions: This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Hyderabad
INR 14.0 - 19.0 Lacs P.A.
Work from Office
Full Time
Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with U.S.-based Biometrics leadership to align deliverables and timelines across global development programs. Support biostatistical leadership by overseeing the development and validation of Statistical Analysis Plans (SAPs), as well as generation of tables, listings, and figures (TLFs) for clinical study reports (CSRs). Supervise the creation and validation of SDTM and ADaM datasets in compliance with CDISC standards. Collaborate with Clinical Data Management leads (where applicable) to ensure effective Clinical Data Management practices and data quality. Ensure alignment of Biometrics activities with overall project goals, timelines, and regulatory requirements. Monitor workload, resourcing, and productivity across the India Biometrics team. Facilitate communication and integration across functional teams (Biostatistics, Statistical Programming & Clinical Data Management). Mentor and support the development of team members across both disciplines. Stay current with industry standards and regulatory expectations in Biostatistics, Statistical Programming , CDISC, and Clinical Data Management practices. Qualifications: Masters degree in Biostatistics, Statistics, Clinical Data Science, Life Sciences, or a related field. 15+ years of experience in the pharmaceutical, biotechnology, or CRO industry within biostatistics, statistical programming, and/or Clinical Data Management. Strong working knowledge of clinical trial processes and relevant regulatory requirements (e.g., GCP, CDISC, BLA/NDA submissions). Hands-on expertise Biometrics with all three functions (Biostatistics, Statistical Programming & Clinical Data Management). Ability to lead and manage cross-functional technical teams. Strong project management, problem-solving, and interpersonal communication skills. Proficiency in relevant tools and platforms (e.g., SAS, R, EDC systems, CDMS, Veeva eTMF, Quality Docs, and eQMS platforms). Experience working in a global team structure and across time zones. Proven track record of leading and managing cross-functional biometrics teams, with experience in overseeing the development and validation of statistical analysis plans and clinical study reports. Experience with CDISC standards (SDTM and ADaM) and proficiency in statistical programming languages (e.g., SAS, R). Familiarity with electronic data capture (EDC) systems and Clinical Data Management systems, with a strong understanding of data integrity and quality practices. Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment, with excellent organizational and problem-solving skills. Strong interpersonal and communication skills, with the ability to collaborate effectively with global teams and senior leadership. Commitment to continuous professional development and staying current with industry trends and best practices. Experience with Microsoft-based applications and ability to learn internal applications/systems, including Veeva platforms such as Quality Docs, eTMF, and CDMS. Experience with eQMS systems is a plus. Working conditions: This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.
Hyderabad
INR 15.0 - 25.0 Lacs P.A.
Work from Office
Full Time
Job Description : As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose : The Statistical Programmer will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities : SAS Programming : You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy). CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications : MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.
Hyderabad
INR 15.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Job purpose : The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities : Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested. Qualifications: BS/BA degree in Computer Science, or work-related experience. 5-8 years related experience. Experience with relational databases and Programming. Experience with developing eDC databases (e.g. Veeva Vault or RAVE), IRT systems (including randomization), and ePRO applications for data collection. Database programming language experience (e.g. SQL, PHP). Website programming language experience is a plus (e.g. HTML, Javascript) Statistical programming language experience is a plus (e.g. SAS, R, Python). Working knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Working conditions: This position operates in an office and/or remote setting. Job may additionally require incumbent to be available outside of regular 9-5 hours to handle priority business needs. Physical requirements: This is a largely sedentary role.
Hyderabad
INR 10.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications. Evaluate Veeva general releases, conduct assessments/proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needs. Lead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance. Ensure critical system operations activitiessuch as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards. Support change management initiatives to ensure effective planning, communication, and adoption of new systems and processes. Liaise with computer system vendors, Quality, and business stakeholders to coordinate implementation activities, applying vendor management best practices. Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders. Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements Work with the business to develop and document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance. Define and oversee documentation of configuration and design specifications. Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation. Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance. Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries. Provide support during U.S. business hours, as required, to ensure incident/issue system resolution across global teams. Management Of GxP Systems Lifecycle Management of system access and permissions. Perform change management activities. Design solutions and manage configuration. Liaise with users to resolve issues. Create reports based on defined requirements. Maintain system documentation. Build systems reports and dashboards. Propose standardization and harmonized approach for configuration. Manage major and minor release including risk-based approach for validation and implementation. Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization. Qualifications: Qualifications include: Bachelor’s degree in computer science or technology with at least 5+ years’ direct experience working with Veeva Vault Technologies implementation and establishing enduring Governance to drive strategic Product Roadmap Deliveries. Experience with the Veeva Vault Development Platform, including QDocs, Training, RIM, QMS, CTMS and cross-domain integrations. Experience and knowledge of quality and regulatory business processes. Direct hands-on experience implementing GxP computerized systems and maintaining validated state. Strong process improvement skills and orientation. Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment. Proven strong communication skills in interacting with users and technical communities. Ability to communicate ideas in both technical and user-friendly language. Collaborative working approach. Computer Skills: Certified Veeva System Administrator - Required. Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.) Experience with Other Regulated Applications would be an asset Database and computer networking knowledge Experience working on SaaS (Software as a Service) systems Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts team success above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Change the approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to build knowledge and skills continuously; Shares expertise with others. Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, keeps commitments, commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies the appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Physical requirements : This is a largely sedentary role.
Hyderabad
INR 10.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications. Evaluate Veeva general releases, conduct assessments/proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needs. Lead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance. Ensure critical system operations activitiessuch as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards. Support change management initiatives to ensure effective planning, communication, and adoption of new systems and processes. Liaise with computer system vendors, Quality, and business stakeholders to coordinate implementation activities, applying vendor management best practices. Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders. Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements Work with the business to develop and document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance. Define and oversee documentation of configuration and design specifications. Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation. Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance. Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries. Provide support during U.S. business hours, as required, to ensure incident/issue system resolution across global teams. Management Of GxP Systems Lifecycle Management of system access and permissions. Perform change management activities. Design solutions and manage configuration. Liaise with users to resolve issues. Create reports based on defined requirements. Maintain system documentation. Build systems reports and dashboards. Propose standardization and harmonized approach for configuration. Manage major and minor release including risk-based approach for validation and implementation. Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization. Qualifications: Qualifications include: Bachelor’s degree in computer science or technology with at least 5+ years’ direct experience working with Veeva Vault Technologies implementation and establishing enduring Governance to drive strategic Product Roadmap Deliveries. Experience with the Veeva Vault Development Platform, including QDocs, Training, RIM, QMS, CTMS and cross-domain integrations. Experience and knowledge of quality and regulatory business processes. Direct hands-on experience implementing GxP computerized systems and maintaining validated state. Strong process improvement skills and orientation. Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment. Proven strong communication skills in interacting with users and technical communities. Ability to communicate ideas in both technical and user-friendly language. Collaborative working approach. Computer Skills: Certified Veeva System Administrator - Required. Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.) Experience with Other Regulated Applications would be an asset Database and computer networking knowledge Experience working on SaaS (Software as a Service) systems Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts team success above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Change the approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to build knowledge and skills continuously; Shares expertise with others. Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, keeps commitments, commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies the appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Physical requirements : This is a largely sedentary role.
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Sri Hari Chandan Appikonda
3 years ago
Still I do not know ..why the hub name is termed as genome valley, should have been named as pharma valley or vaccine valley ..no significant genomics...
Abdul Basith
4 years ago
Thanks for Honorable AP CM Nara Chandrababu Naidu for Completed this whole Project #GenomeValley. Proud to have u.. 🙏🇮🇳🙏 …
Ravindra रविन्द्र उराँव मनिका Oraon
3 years ago
2nd dose
SUKANTA SAHA
3 years ago
Global Biotech hub
Mohammad Karim
3 years ago
ramchandar ram
3 years ago
shareef munna
4 years ago
Anuradha Kode
5 years ago
lingareddy thouda
7 years ago
Kalyani Kotte
11 years ago
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