6 Study Director Jobs

You will be responsible for functioning as a Study Director for general toxicology studies, including acute, repeated dose toxicity studies, and PK studies. Additionally, you will function as a Study Personnel for general toxicology studies led by other Study Directors. Your duties will involve the preparation of study plans, study plan amendments, deviations, study reports, SOPs, and their review. Furthermore, you will be tasked with maintaining the in vivo laboratory and providing assistance in departmental activities as required. In order to enhance the capabilities of the team, you will be required to perform validation of new studies. Your role will also include the compilation, verification, and statistical analysis of study data. You will be accountable for the procurement, handling, storage, and disposal of chemicals/items related to general toxicity studies. Additionally, you will be responsible for operating and maintaining laboratory equipment used in non-clinical safety studies. It will be essential for you to collaborate with the Quality Assurance (QA) team for GLP studies and ensure facility compliance.,

Role & responsibilities 1. Act as Study Director for various Pre-Clinical studies as per guidelines 2. Conduct, schedule & report toxicological studies for various products in pre-clinical studies 3. Conduct a Pharmacological evaluation of various pharmaceutical products 4. Preparation of SOP & documentation as per guidelines 5. Ensuring facility readiness as per regulatory guidelines & audits

Can perform Acute toxicity studies (Acute 6 Pack) as per OECD test guideline . Acute Oral, Acute Dermal, Acute Inhalation, Acute Dermal Irritation, Acute Eye Irritation and Skin Sensitisation studies Required Candidate profile Can perform Acute toxicity studies (Acute 6 Pack) as per OECD test guideline . Acute Oral, Acute Dermal, Acute Inhalation, Acute Dermal Irritation, Acute Eye Irritation and Skin Sensitisation studies

Job description Job title: Senior Associate Scientist Job location: Bangalore Job grade: 8-II About syngene: syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: As a Study Director - Toxicology: Responsible for ensuring that GLP toxicology studies; acute, repeat dose and reproduction are carried out to the required scientific and regulatory standards as per Global regulatory guidelines [ICH/OECD]. Function as single point of study control, overall responsibility for the scientific, technical and regulatory conduct of studies, scientific interpretation, documentation and reporting of results. Role Accountabilities: Study Director for in vivo toxicology studies Coordination with local cross-functional teams like veterinary science, biopharmaceutics, bioanalysis, pharmacokinetics or in vitro biology before, during and after execution of toxicology studies Conduct of in-life phases of toxicology studies in rats, mice and rabbits Dose administration in rats, mice and rabbits with various routes of administration Use of on-line data capture system- Pristima Blood sample collection for toxicokinetic Assistance during necropsy activities such as organ weighing, data entry in PROVANTIS software Assistance in conducting rabbit electrophysiology studies Coordination with veterinary science team IAEC meetings- preparation and maintenance of FORM-B and FORM-D Blood collection in rats and mice via different routes for clinical pathology analyses Preparation and following of in-house SOPs Co-ordination for preventive maintenance and calibration of instruments. Archival of materials from toxicology studies. Any other duties given from time to time by the line manager Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 3-6 years Skills and Capabilities: 1. Good understanding and hands on Experience of toxicology. Preferably have knowledge of related disciplines, toxicokinetics, pathology and analytical chemistry. 2. Candidate working in or have relevant experience in contract research organization will be preferred. Education MVSc Equal Opportunity Employer: .

Job Title: Principal Scientist - (Study Director in Toxicology) Location: Bangalore Industry: Pre-clinical Contract Research Organization Job Type: Full-time About the Role: We are seeking an experienced Principal Scientist to lead our toxicology studies, designing, conducting, and reporting non-clinical safety studies (GLP and non-GLP) in support of drug development and regulatory submissions. This role demands strong scientific leadership, regulatory expertise, and cross-functional collaboration. Key Responsibilities: Design, conduct, and report non-clinical safety studies (GLP and non-GLP) for drug development and regulatory submissions. Provide scientific leadership and ensure regulatory compliance in toxicology studies. Collaborate with cross-functional teams to ensure study integrity and success. Requirements: Experience: 8-10 years of relevant experience in toxicology or a related field. Education: Ph.D. or Master's degree in Veterinary Sciences or Biosciences. Desirable Certifications: DABT Certification and FELASA certification. Skills: Expertise in repeat dose toxicity, teratology, and reproductive toxicity experimentation. Strong understanding of pharmaceutical R&D and agrochemical testing processes. Excellent team working and leadership skills. In-depth knowledge of GLP and regulatory guidelines. Strong scientific writing and communication skills. Ability to manage multiple projects and lead teams. Proficiency in data analysis and interpretation. Behavioral Competencies: Excellent communication and adaptability. Effective time management. Continuous learning and improvement. Structured work approach. What We Offer: Opportunity to work in a dynamic CRO environment. Collaborative team. Growth opportunities. If you are a motivated professional looking to lead in toxicology, apply now with your resume. How to Apply: Email: Sekhar.Sompalli@advinus.eurofinsasia.com

Designation: Calibration and Documentation Engineer Job Location: Bangalore Department: Chemical Development Engineering and Maintenance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose To support characterization, analytical method development, validation, and dose formulation analysis. The role will involve conducting all work in compliance with applicable regulatory requirements and Good Laboratory Practice. Key Responsibilities: Assist in the conduct of the study in compliance with the Principles of Good Laboratory Practice. Operating analytical equipment and ancillary equipment Compliance with the study plan and Standard Operating Procedures applicable to their involvement in the study. Recording of data with compliance to ALCOA+ principles Documenting and communicating and deviation to supervisor/team lead/study director Ensuring health and safety practices at the workplace Communicate with Management, QAU, Document Controller, TICO, and Archivist as per the Study Director's instructions. Verify the calibration and maintenance of the instrument/equipment before the start of the experiment. Educational Qualification: Bachelor of Engineering (Any Specialization) Technical/Functional Skills: Strong knowledge on calibration of Field instrument Strong Knowledge on cGMP documentation and preparation of standard operating instruction. Strong knowledge on handling of Master instruments. Experience on preparing Schedules for calibration and Execution. Experience on Servicing and trouble shooting field instruments. Experience on handling internal and External audits Knowledge on compliance documents and filling data sheet. Experience: 3-9 years in calibration and documentation Behavioral Skills: Good communication skill, both verbal and written High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.