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.
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.
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.
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.
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.
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.
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.
Job Purpose Ocugen Inc, is seeking a Financial Reporting Analyst reporting to the Director of SEC Reporting. This role will play a key role in various elements of the Companys SEC Reporting/Technical Accounting functions. The ideal candidate will have a working knowledge of SEC regulations, U.S. GAAP accounting principles, and requirements of financial statements and related disclosures, along with the ability to effectively research accounting topics. Candidate will interface regularly with other key members of the corporate accounting, finance, legal, human resources and the external auditors. Responsibilities Prepare accurate and timely financial disclosures for SEC filings, including Forms 10-K and 10-Q. Support the development of financial content for Investor Relations communications, including 8-Ks, earnings call scripts, and investor presentations. Leverage automation tools to streamline data gathering and enhance reporting workflows. Analyze complex and non-routine transactions, providing insight into financial and operational impacts. Research and interpret U.S. GAAP and SEC accounting guidance; draft technical accounting memos to support conclusions. Contribute to valuation activities, including the assessment and reporting of stock-based compensation. Support Sarbanes-Oxley (SOX) compliance efforts by executing and maintaining internal controls over financial reporting. Collaborate cross-functionally with internal stakeholders to ensure accurate, compliant, and insightful financial reporting. Required Experience and Qualifications Bachelors degree in accounting. Minimum of 4 years of experience in public accounting or a related industry role. Strong understanding and interest in applying U.S. GAAP and SEC regulations to real-world scenarios. Highly detail-oriented, organized, and able to manage multiple priorities effectively. Excellent written and verbal communication skills. Proven ability to work collaboratively across teams and build strong working relationships. Strong analytical and problem-solving skills with the ability to think independently. Comfortable operating in a fast-paced and dynamic work environment. Preferred Qualifications Experience in SEC financial reporting. Background in Big 4 accounting firm or experience within a public company environment. Familiarity with NetSuite general ledger system and/or Workiva reporting tools. 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.
Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, and timelines. Lead and mentor scientific staff supporting pharmacology operations. Analyze and compile data, ensuring GxP-compliant documentation and reporting. Contribute to the drafting and revision of regulatory documents including investigator brochures and study reports. Toxicology & Safety Assessment Lead toxicology strategy across discovery, preclinical, and clinical development phases, with an emphasis on human risk assessment and elucidation of toxicity mechanisms for novel therapeutic targets. Act as the primary liaison with CROs, overseeing study conduct and coordinating with technical, veterinary, and scientific personnel. Manage outsourced GLP and non-GLP studies to ensure adherence to protocols, regulatory requirements, safety standards, and SOPs. Integrate expertise in toxicology, pharmacology, ADME, and regulatory guidelines to design robust nonclinical safety assessment strategies. Identify and apply innovative approaches to streamline and accelerate nonclinical development timelines. Critically evaluate study protocols, data sets, and reports to ensure scientific validity and regulatory compliance. Regulatory and Cross-Functional Support Lead or support the preparation of regulatory submissions (e.g., IND, CTA, IB, NDA, BLA). Develop and implement program-specific toxicology plans in collaboration with cross-functional project teams to support compound progression. Represent toxicology and safety pharmacology functions on multidisciplinary project teams. Author and review toxicology reports and regulatory documents; contribute to regulatory submissions and interactions with global health authorities. Represent toxicology function on multidisciplinary teams supporting all stages of drug development. Contributes to the development of high-quality regulatory submissions for global clinical trials and marketing authorizations. Communicate findings and recommendations effectively to project teams and senior leadership. Qualifications and skills : Ph.D. in Toxicology, Pharmacology, or a related field. Strong knowledge of regulatory guidelines (ICH, FDA, EMA) and GxP standards. Minimum 5 years of relevant industry experience in preclinical drug development, or equivalent regulatory experience. Proven experience in designing, managing, and interpreting non-clinical safety and efficacy studies. Demonstrated ability to prepare and review nonclinical sections of regulatory documents like CTA, IND, IB, NDA, BLA, etc. Effective leadership, project management, and cross-functional collaboration skills. Willingness to travel as needed. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. 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.
1. JOB PURPOSE Ocugen Inc, is seeking a Financial Reporting Analyst reporting to the Director of SEC Reporting. This role will play a key role in various elements of the Companys SEC Reporting/Technical Accounting functions. The ideal candidate will have a working knowledge of SEC regulations, U.S. GAAP accounting principles, and requirements of financial statements and related disclosures, along with the ability to effectively research accounting topics. Candidate will interface regularly with other key members of the corporate accounting, finance, legal, human resources and the external auditors. 2. DUTIES AND RESPONSIBILITIES Prepare financial disclosures for Forms 10-K, 10-Q; • Assist in the preparation of all financial information included in Investor Relations documents (8-K, scripts, investor presentations, etc.); • Develop a fluency with available automation tools, utilize these to streamline data preparation and existing workflows; • Analyze complex transactions; • Research and interpret accounting guidance, prepare technical accounting position papers that document facts and circumstances and resulting conclusion; Assist in valuation exercises including the valuation of Stock based compensation; • Have responsibility for SOX compliance activities, including executing internal controls. 3. QUALIFICATIONS Degree in Accounting • 4 years of public accounting or related industry experience • Highly detail oriented and organized • Aptitude and enthusiasm to apply U.S. GAAP and SEC rules and regulations to real world examples • Strong written and verbal communications skills • Excellent team player who can build and leverage working relationships • Strong analytical skills and ability to think independently • Flexible within a rapidly changing, dynamic work environment • SEC Reporting experience • Big 4 or public company experience • Experience with Netsuite GL, and/or Workiva software 4. 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. 5. PHYSICAL REQUIREMENTS This position requires sitting (90%), standing (5%), and walking (5%). It requires computer work involving extensive use of keyboard, mouse, and monitor.
1. JOB PURPOSE We are seeking a highly experienced and motivated Computer Vision and Image Analysis Engineer to join our AI team focused on advancing visual computing in the healthcare and life sciences domains, especially ophthalmology. You will develop innovative algorithms and AI models to process and analyze complex biomedical imagesparticularly retinal scans—supporting drug discovery, clinical workflows, and treatment optimization. This role combines cutting-edge AI with domain-specific challenges in biomedical imaging, offering you the opportunity to work closely with interdisciplinary teams of engineers, scientists, and healthcare professionals. 2. DUTIES AND RESPONSIBILITIES Algorithm & Model Development Design, develop, and optimize state-of-the-art AI/computer vision models for a wide range of retinal imaging modalities (e.g., OCT, FAF, fundus, angiography, ultra-widefield, etc.). Build and refine deep learning-based solutions for disease diagnosis, clinical grading, disease activity monitoring, efficacy assessment and progression modeling across multiple retinal diseases (e.g. diabetic retinopathy, AMD, glaucoma). Develop and validate algorithms for image classification, segmentation, object detection and quantitative feature extraction, including biomarkers relevant to clinical trial endpoints. Create methods for image enhancement, transformation, denoising and pre/post-processing to support reliable downstream analysis in clinical trial settings. Research & Innovation Stay up-to-date with cutting-edge advancements in AI, ophthalmic imaging and clinical trial methodologies, and translate these into novel solutions that meet regulatory and scientific requirements. Develop research and product roadmaps that align technology innovation with clinical development strategies and business objectives. Clinical Trial Support & Implementation Design and implement AI tools to support clinical trials, including data ingestion and harmonization, automated analysis of imaging datasets for trial endpoints, and generation of quantitative metrics for efficacy assessments. Work with clinical teams and ophthalmologists to define clinically relevant outputs and ensure models meet the needs of protocol-defined objectives and regulatory standards. Contribute to the development of validation plans, clinical testing strategies, and documentation for regulatory submission of AI-based tools. System Integration & Deployment Integrate AI/computer vision solutions into clinical and cloud-based platforms using Docker, Kubernetes and SaaS infrastructures, with specific focus on scalability, security and traceability for clinical trial applications. Collaborate with system vendors and stakeholders for implementation, testing and deployment of validated AI tools in regulated environments. Collaboration & Communication Work closely with ophthalmologists, medical affairs, biostatisticians and machine learning engineers to translate clinical and scientific requirements into scalable, deployable technical solutions. Effectively communicate results, research findings and technical roadmaps to both scientific and non-technical stakeholders, including clinical development teams. 3. QUALIFICATIONS & TECHNICAL SKILLS Qualifications: Master’s degree in Computer Science, AI, Biomedical Engineering, or a related field. 5+ years of hands-on experience in computer vision, image analysis, and machine learning in healthcare or life sciences. Proven ability to independently lead AI research and model development. Technical Skills : I. Programming & Frameworks Languages: Python (primary), C++, Java, R Libraries/Frameworks: OpenCV, TensorFlow, PyTorch, scikit-learn, Keras II. AI & Machine Learning Deep understanding of ML algorithms: CNNs, Vision Transformers, GANs, RNNs, SVMs, Random Forests, XGBoost Expertise in model optimization and deployment using multi-GPU systems , Docker , and Kubernetes III. Computer Vision Techniques Image classification (VGG, ResNet, EfficientNet) Object detection (YOLO, SSD, Faster R-CNN) Image segmentation (U-Net, Mask R-CNN) Feature extraction (SIFT, SURF, ORB) Image enhancement and transformation methods IV. Cloud & Infrastructure Familiarity with cloud platforms (AWS, Azure, GCP) Experience with SaaS, containerization, and high-performance computing for large-scale data V. Domain Expertise (Preferred) Ophthalmic imaging and diseases (e.g., fundus, OCT, glaucoma, diabetic retinopathy) Biomedical imaging in areas like cancer, neuroscience, immunology, or cardiovascular research Drug discovery and clinical trial workflows VI. Soft Skills & Competencies Strong problem-solving and analytical thinking Excellent communication skills (technical and non-technical audiences) High attention to detail with large, unstructured datasets Independent, self-driven work ethic with collaborative mindset 4. WORKING CONDITIONS On-site role with occasional travel (up to 10%) Office-based work environment This is a largely sedentary position, requiring long periods of screen time
1. JOB PURPOSE Join Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Pharmacovigilance teams to advance gene & cell therapy programs from Phase IIII. Unique opportunity to bridge clinical science and business strategy in a fast-paced biotech environment. Join Ocugen’s Clinical organization (Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Pharmacovigilance) to contribute across the full spectrum of drug development in gene and cell therapies. 2. DUTIES AND RESPONSIBILITIES Support protocol development, amendments, IB/ICF creation, and regulatory submissions (INDs, BLAs, CTAs). Participate in medical monitoring: eligibility review, safety signals, and protocol deviations. Analyze clinical data for CSRs, publications, abstracts, and posters. Contribute to clinical trial execution: site selection, start-up, recruitment, milestones, GCP compliance. Assist in pharmacovigilance: safety reviews, narratives, safety reports. Collaborate with KOLs, Medical Affairs, Regulatory, and Commercial teams; conduct competitive landscape analysis. Role Highlights: Contribute to 3 BLAs in the next three years from early- to late-stage development. Support and Develop Study Protocol, Investigators Brochure, and Informed consent form (ICF) development; oversee site start-up, recruitment, and milestones. Conduct medical monitoring: eligibility review, safety assessment, and risk–benefit evaluation. Lead/assist in scientific publications, posters, and conference presentations. Partner with the Center for Commercialization to support launch readiness. Develop, standardize and implement surgical techniques for ocular gene therapy programs. Gain cross-functional exposure, bridging clinical science and business strategy from Phase I–III. 3. QUALIFICATIONS & SKILLS MD (Vitreo-retinal surgeon preferred) with strong interest in clinical research & drug development. Skilled in scientific writing, data analysis, and cross-functional collaboration. Detail-oriented, organized, self-motivated, industry or clinical trial experience a plus 4. WORKING CONDITIONS Operates in an office setting in a sedentary role
Job purpose: The Clinical Data Manager is a key member of Ocugens clinical data management team. This individual will be responsible for ensuring quality data collection and management processes, CRF development, database design, data monitoring, and validation of entered data for clinical development, and/or marketed products. This individual will work closely with the Biometrics team and the rest of the team at Ocugen to execute the data collection needs of the research studies. Duties and responsibilities: Establishes data flow from collection to final analysis through a data management plan. Ensures the accurate collection of electronic data. Collaborates on implementation and collection of data supporting for research protocols. Develops data transfer specifications and data review specifications and/or data quality review plan specifications. Develops program standard and study-specific electronic Case Report Forms (eCRFs). Develop and revise SOPs, implement DMP and strategies. Develop and implement risk management strategies. Prepare and participate in Audits. Develops edit checks, 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. Ensure all required documentation is completed in a timely manner. Lead junior Data management staff. Collaborates with other functional teams to ensure proper output of clinical data as needed for deliverables. Additional tasks and projects as requested. Qualifications : BS degree in clinical, biological or mathematical sciences, or related field or nursing qualification, or work- related equivalent. 6+ years direct clinical data management experience in pharmaceutical development or CRO environment. Experience with clinical trials. Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection. Strong 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. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. Experience in working with USA biopharmaceuticals/pharmaceuticals companies or client. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions : 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. Physical requirements: This is a largely sedentary role.
JOB DESCRIPTION Job title AI Engineer Reports to Operation Head Job purpose Application of AI across variety of high-impact special projects across research, clinical, and commercial. Duties and responsibilities The successful candidate will work closely with R&D and Corporate stakeholders under Ocugens R&D and Business organization to develop predictive AI/ML models using large-scale datasets. Build and fine-tune LLM-based AI models for text and document understanding. Implement RAG & agent-based systems using Lang Chain / Lang Graph / Llama Index. Integrate Azure AI services (OpenAI, ML, Document Intelligence) into scalable APIs. Build and deploy AI workloads using Fast API / Flask, Docker, and Kubernetes (AKS). Automate pipelines through Azure DevOps / GitHub Actions (CI/CD) and monitor via App Insights. Collaborate with research teams to shape reliable, domain-specific AI workflows. Qualifications BE or B. Tech, in computer Science, Artificial Intelligence & machine learning. 12-year industry experience. Hands On Expertise in AI & MLOps 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. N/A
Job title Quality Management System (QMS) Manager Reports to Operation Head Job purpose : Establishment, implementation, and continuous improvement of the company's. Quality Management System (QMS) to support its clinical-stage biopharmaceutical development programs while ensuring compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH) and GxP standards (GMP, GDP, GCP, GLP). Cross-functional collaboration to embed a proactive quality culture, align GxP activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness. Duties and responsibilities QMS Development & Implementation Develop, implement, and maintain a phase-appropriate Quality Management System aligned with FDA, EMA, and ICH requirements. Establish, review, and update Quality System documentation (SOPs, policies, templates) to support GxP operations (GMP, GDP, GCP, GLP). Serve as system owner for the electronic QMS (e.g., Veeva,) and ensure effective document control. Drive QMS maturity and scalability as programs advance from early clinical to IND, IMPD, and BLA stages. Monitor QMS performance through defined KPIs and implement continuous improvement initiatives Compliance, Audits & Quality Oversight Ensure organizational compliance with internal quality standards and global regulatory expectations. Lead internal audit programs and coordinate external audits and inspections (regulatory, customer, or vendor). Manage audit findings and CAPAs to ensure timely closure and sustained compliance. Partner with cross-functional teams (Clinical, Manufacturing, Regulatory) to ensure consistent application of quality principles. Support vendor qualification and ongoing oversight of CMOs, CROs, and testing laboratories. Deviation, CAPA, and Change Control Oversee deviation, investigation, and CAPA systems to ensure effective root cause analysis and preventive action. Manage change control processes for systems, procedures, and documentation, including risk and impact assessments per ICH Q9. Foster a culture of accountability and proactive issue prevention across functions. Document & Training Management Administer document management and training systems to maintain inspection readiness. Ensure training programs align with current procedures, regulatory requirements, and company quality objectives. Track and report compliance metrics, including training completion and document revision cycles. Inspection Readiness and Continuous Improvement Support preparation for regulatory inspections and sponsor audits, ensuring organizational readiness Conduct periodic management reviews of QMS performance, providing metrics and compliance trend analyses to senior leadership Champion continuous improvement and quality culture initiatives to enhance operational excellence Qualifications and Experience Master's or doctorate degree in Life Sciences, Pharmacy, Biotechnology, or related discipline. 8 to 12 years of experience in Quality Assurance or Quality Systems within the biotechnology or biopharmaceutical industry Proven track record in developing, implementing, and managing QMS within GMP-regulated environments Familiarity with GxP compliance requirements across clinical development and manufacturing Experience supporting regulatory inspections (FDA, EMA) and interacting with CMOs, CROs, and regulatory authorities Hands-on experience with electronic QMS platforms (e.g., Veeva,) is mandatory Prior experience managing an electronic QMS platform desirable Prior work experience in clinical-stage or early commercial-stage biotech preferred A Strong command of phase-appropriate GxP and ICH Q-series guidelines Skilled in eQMS administration, quality documentation, and compliance monitoring Proficient in Veeva Vault and Regulatory Information Management Systems (RIMS) to streamline document management and regulatory compliance processes Effective communicator with cross-functional teams across R&D, Clinical, Manufacturing, and Regulatory functions Excellent analytical thinking, problem-solving, and organizational skills with the ability to manage multiple Priorities Deep understanding of bio-therapeutics manufacturing, gene/cell therapy operations Strong knowledge of cGMP, GLP, and regulatory compliance frameworks Experience in managing global quality audits, CAPA, and risk assessments. 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. Direct Reports : N/A
Job purpose : Design, develop, and manage scalable MLOps pipelines for building, training, and deploying predictive and generative LLM models on cloud infrastructure. The role supports automation, monitoring, and optimization of AI workflows across research, clinical, and commercial initiatives to enable data-driven decision-making and operational efficiency. Duties and responsibilities : The successful candidate will work closely with R&D and Corporate stakeholders under Ocugens R&D and Business organization. Design, develop, and maintain end-to-end MLOps pipelines on Azure for training, evaluating, and deploying AI and LLM-based models across multiple environments. Integrate and manage Azure OpenAI Service, Azure AI Search, Azure Document Intelligence, and Azure Blob Storage for model orchestration, data ingestion, and large-scale retrieval workflows. Build and manage CI/CD pipelines using Azure DevOps or GitHub Actions to automate code builds, testing, model deployment, and versioning. Implement infrastructure-as-code for reproducible environment setup using tools like Bicep or Terraform , ensuring consistency across R&D and production environments. Configure Azure Container Apps, Container Registry, and Kubernetes clusters to support scalable and fault-tolerant model deployment. Develop data pipelines for ingesting, cleaning, and indexing structured and unstructured data into Azure Blob and Azure AI Search for downstream AI workloads. Monitor and optimize model inference performance, latency, and cost , leveraging Azure Monitoring, Application Insights, and autoscaling strategies. Track and manage token utilization and billing for Azure OpenAI and other AI services to ensure efficient resource consumption. Implement secure storage and access control using Azure Key Vault, role-based access, and compliance policies. Collaborate with AI, backend, and DevOps teams to deploy and maintain LLM and data analytics models integrated with enterprise APIs and dashboards. Maintain documentation of pipelines, deployment workflows, and cost reports , supporting transparency and operational readiness. Qualifications : B.Tech/ M.Tech in Computer Science and Engineering 2- 4 years of industry experience Ability to deliver on tight deadlines 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. 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. Physical requirements : This is a largely sedentary role. Direct reports: N/A
JOB DESCRIPTION Job title : Lead Preclinical Science and translational research ( Neuroscience) Reports to : Chief Scientific Officer Job purpose This role is critical in driving the design, execution, and interpretation of preclinical studies to support the discovery and development of novel therapeutics for neurological disorders. The ideal candidate will bring deep expertise in neuroscience, pharmacology, and translational science, with a proven track record of advancing drug candidates including biologics, and gene therapies from early discovery through IND-enabling studies. Duties and responsibilities Scientific Lead: Lead preclinical strategy and execution for neuroscience drug discovery programs. Design and oversee in vivo and in vitro studies to evaluate pharmacodynamics, efficacy, and safety. Guide target validation, biomarker development, and mechanism-of-action studies. Ability to bridge discovery and translational research, ensuring that preclinical findings inform clinical development. Program Management: Serve as the preclinical lead on cross-functional project teams. Collaborate with medicinal chemistry, DMPK, toxicology, and clinical teams to ensure seamless transition from discovery to development. Manage timelines, budgets, and deliverables for preclinical workstreams. Team Development: Mentor and supervise a team of scientists and research associates. Foster a culture of scientific excellence, innovation, and collaboration. External Collaboration: Identify and manage CROs and academic partnerships to support preclinical research. Represent the company at scientific conferences and contribute to publications and patents. Regulatory Support: Contribute to the preparation of regulatory documents including INDs, IBs, and briefing packages. Ensure compliance with GLP and other regulatory standards as needed. Program Advancement Support IND-enabling studies and contribute to regulatory submissions Translate preclinical findings into clinical hypotheses and biomarker strategies Qualifications Ph.D. in Neuroscience, Pharmacology, or a related discipline; postdoctoral experience strongly preferred. 8+ years of relevant experience in preclinical drug discovery (industry or translational research). Proven track record of leading neuroscience programs to preclinical candidate nomination. Expertise in neurobiology, in vivo pharmacology, and translational models of CNS disorders. Familiarity with modern neuroscience tools (e.g., optogenetics, imaging, electrophysiology, omics approaches). Strong leadership, communication, and project management skills. Experience managing and mentoring scientific staff. Experience with IND-enabling studies and regulatory documentation. Knowledge of biomarker discovery and translational pharmacology. Demonstrated success in partnership management (academia or CROs). Publication record in high-impact neuroscience or pharmacology journals. Preferred Experience : Neurological animal models : Hands-on experience with rodent models of neurodegenerative, neurodevelopmental disorders, including behavioral, histological, and molecular assessments. In vivo neuroscience expertise: Proficient in designing and executing rodent models of neurodegenerative (e.g., Alzheimers, Parkinsons), neurodevelopmental (e.g., autism, Rett syndrome), and psychiatric disorders (e.g., depression, schizophrenia). Behavioral phenotyping: Skilled in conducting and interpreting behavioral assays such as Morris water maze, open field, rotarod, elevated plus maze, and social interaction tests. Histological and molecular analysis: Experience with immunohistochemistry, in situ hybridization, and quantification of neuroinflammation, synaptic integrity, and neurodegeneration markers. Electrophysiology and imaging: Familiarity with in vivo and ex vivo electrophysiological recordings and neuroimaging techniques (e.g., MRI, PET) for functional assessments. Cell-based assays : Proficiency in designing and executing in vitro assays using primary neurons, iPSC-derived cells, or immortalized cell lines to assess target engagement, toxicity, and mechanism of action. Drug testing : Experience in evaluating pharmacological agents (small molecules, biologics) in preclinical models, including dose-response, PK/PD, and efficacy studies. Gene therapy product testing : Vector design and validation: Understanding of AAV, lentiviral, and non-viral vector systems for CNS-targeted gene delivery. Biodistribution and expression studies: Experience in evaluating transgene expression, vector tropism, and tissue-specific targeting using qPCR, Western blotting, and immunofluorescence. Efficacy and safety assessment: Conducting dose-response, durability, and off-target effect studies in animal models; familiarity with GLP-compliant safety pharmacology and toxicology studies. Experience in biotech/pharma settings with IND-enabling studies. Experience in RT-qPCR and data analysis. SDS-PAGE, Immunoblotting, ELISA and antibody binding assays and data analysis. Proficient knowledge in neuroimmunology, synaptic biology, or neurodevelopmental disorders. Preclinical data analysis, statistical operations (e.g., ANOVA, t-tests, regression) in preclinical or neuroscience research, graphical representation of data, including power analysis, ANOVA, regression modeling, and multivariate analysis for robust data interpretation. Ability to produce and/or analyze publication-ready data. Extensive knowledge of Biomarkers (Identify molecular signatures of disease progression or therapeutic response); Mechanism of Action Studies (Reveal how drugs or gene therapies affect molecular pathways); Target Identification & Validation (Discover novel drug targets through differential expression or pathway analysis). Experience with electrophysiology, high-content imaging, or omics-based approaches (Genomics, Proteomics, Transcriptomics and Metabolomics) is a plus. Knowledge of emerging modalities (e.g., gene therapy, RNA-based therapeutics, biologics, Antibody-drug conjugates and CAR-T therapies, etc.,). Working conditions : 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. Physical requirements This is a largely sedentary role. Direct reports N/A
JOB DESCRIPTION Job title Manager / Sr Manager- Veeva Vault Configuration and Admin (IT-QA) Reports to Operations Head Job purpose Focus: Technical configuration and system integration across Vault modules Document management and system administration (Quality Docs / EDMS) Core Function: Configure Vault to meet business needs and ensure system validation. Ensure controlled documents are accurate, compliant, and accessible. Job Location: Hyderabad, India. Key Responsibilities Administer and maintain Veeva Vault DMS (Quality Docs or equivalent). Configure Vault modules (Quality Docs, QMS, RIM, Promo Mats, eTMF). Oversee document lifecycle - creation to archiving - per GxP and quality standards. Maintain version control, metadata, and audit readiness. Configure system settings for optimal performance. Provide user support and training. Generate compliance and performance reports. Liaise with Veeva Support for escalations. Manage lifecycles, workflows, permissions, and metadata. Handle user management and environment promotions. Support integrations with enterprise systems (SAP, Salesforce, etc). Author configuration specs, validation scripts, and test records. Train users and support system releases and regression testing. Duties and responsibilities Administer and maintain the Veeva Vault Document Management System (DMS) , ensuring document accuracy, integrity, version control, and accessibility in compliance with regulatory and quality standards. Configure and customize system settings to meet business requirements, ensuring optimal system performance and user experience. Provide technical and functional support to end-users of the Veeva Vault application, including troubleshooting, issue resolution, and managing configuration change requests. Collaborate with cross-functional and integrated teams to identify, analyse, and resolve issues related to Veeva Vault integrations with other enterprise systems. Oversee the entire document lifecycle , including creation, review, approval, distribution, and archiving, in compliance with company policies and GxP regulations. Manage and maintain the companys Electronic Document Management System (EDMS) for efficient document organization, retrieval, and audit readiness. Implement and enforce strict version control and metadata management to ensure users access only the latest, approved documents. Handle non-standard or escalated system issues, coordinating with vendors (e.g., Veeva Support) to resolve major technical problems. Develop and deliver training programs for staff on document control processes, Veeva Vault functionalities, and best practices. Generate and present reports and dashboards on document control metrics, system performance, and compliance trends to management. Configure Veeva Vault modules such as QualityDocs, QMS, RIM, PromoMats, or eTMF according to business requirements. Manage document types, lifecycles, workflows, roles, permissions, and metadata. Support Vault administrative tasks, including user management, security settings, and environment promotion. Collaborate with business process owners to gather requirements and translate them into Vault configurations. Develop and maintain configuration specifications, test scripts, and validation documentation in compliance with GxP. Assist in integration between Vault and other enterprise systems (e.g., SAP, JD Edwards, Salesforce). Provide training and support for end users and business administrators. Participate in release management, regression testing, and change control processes. Develop and maintain configuration specifications, test scripts, and validation documentation in compliance with GxP. Familiarity with CSV / CSA validation and electronic records. Qualification Bachelors or masters in computer science, Life Sciences, or related field. 8+ years of experience with Veeva Vault configuration. Strong understanding of GxP, 21 CFR Part 11, and validation requirements. Strong understanding of document control, compliance, and GxP. Experience in a regulated environment (QA, Regulatory, or Clinical Operations). Proficiency in Veeva Quality Docs. Working conditions: 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. Physical requirements This is a largely sedentary role. Direct reports N/A
FIND ON MAP