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3.0 - 7.0 years
0 Lacs
nagpur, maharashtra
On-site
The Eco Toxicologist position based in Nagpur, India requires the candidate to hold a minimum of an M.Sc (or equivalent) in Toxicology, Ecotoxicology, Environmental Science, Fisheries, or Zoology. A PhD in the relevant field would be preferred. Additionally, familiarity and hands-on experience with Biodegradability, cell biology, fish studies & culture, and algal studies would be advantageous. The ideal candidate should have prior experience in conducting studies related to fish, algae, and Daphnia. Knowledge and experience in biodegradability are also desirable. Responsibilities include conducting desktop research, analyzing technical literature, reviewing, and summarizing scientific literature and pre-clinical study reports. The candidate will be required to interpret and apply existing information and data on chemicals to meet regulatory requirements. Additionally, the role involves coordinating with the laboratory, monitoring studies, and reviewing reports.,
Posted 1 week ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems dedicated to making genomics useful for all. Our integrated Indian global hub in Bengaluru, Illumina India Biotechnology Private Limited, is focused on technology activities that will help usher in the next wave of innovation in healthcare and medical research. If you are eager to work on challenging projects that use cutting-edge technology to transform the future of healthcare, this is your chance to join a truly remarkable team. We are currently seeking an EHS Specialist to join our talented team in Bangalore. In this role, you will support the Global EHS strategy for compliance and risk management in the delivery of Safety Data Sheets (SDS) and related product and chemical management information and processes. Your responsibilities will include authoring product SDS using the SAP EHS module, maintaining data integrity and compliance with regulatory standards, collaborating with business stakeholders, planning and executing the transition of SDSs to the SAP EHS Module, ensuring adherence to relevant regulations and guidelines, providing training to employees and customers, supporting documentation of existing and revised business processes, and identifying opportunities for process improvements. The ideal candidate will have a Bachelor's Degree in a related discipline with 2 years of industry experience, proven expertise in the SAP EHS Module, experience in project management, working knowledge of the Global Harmonized System (GHS), and the ability to learn technical processes quickly. Strong experience in biotechnology, life sciences, or pharmaceutical-related industry, a strong understanding of chemistry, chemical hazards, and toxicology, knowledge of relevant regulations, and good technical abilities in information management system execution and support are also required. Additionally, strong teamwork skills, the ability to build strong relationships, energetic and positive enthusiastic disposition, strong verbal and written communication skills, interpersonal and organizational skills, attention to detail, and a proactive and adaptable mindset are essential for success in this role. If you are hardworking, committed to customer excellence, proactive, adaptable to changing environments and priorities, highly organized, and possess a growth mindset, then we encourage you to apply for this position and be a valuable part of our team at Illumina.,
Posted 1 week ago
0 years
10 - 16 Lacs
Delhi
On-site
ROLES & RESPONSIBILITIES: Manage the data gathering and compilation of studies (toxicology, chemical, efficacy) necessary for the submission and support of registrations Closely working with CIBRC/FCO authorities to get registrations in time Regular follow up with regulatory authorities on submission of files Ensure all dossiers are prepared and submitted as per specifications to registration authorities within specified timeline. Competitive intelligence on regular basis on new products as per CIBRC minutes Regulatory affairs representative on cross-functional project teams Maintaining appropriate files and databases to document such activities Collaborate and coordinate with J-makers/partners/suppliers and product development team Manage projects to maintain product registrations including label revisions, CIBRC responses, registration reviews etc. Serve on cross functional projects to provide subject matter expertise support to the business. Prepare and maintain labels ensuring compliance with regulatory authority Provide necessary compliance reports as and when required by regulatory authority Participate in a multidisciplinary technical team to develop regulatory strategies and solutions for a wide range of Crop Protection & Nutrition products Responsible for regulatory monthly status reports/updates Monitor, assess potential impact, and develop appropriate action plans for new or emerging regulations, initiatives, and regulatory changes RTT applications and sample inventory management of new developmental products Participate in external engagement activities through industry trade associations, work groups or other relevant initiatives, as assigned (from time to time) Preferred Industry: Agri inputs (Agrochem/Fertilizers/Pesticides) Job Type: Full-time Pay: ₹1,000,000.00 - ₹1,600,000.00 per year Benefits: Health insurance Leave encashment Provident Fund Work Location: In person
Posted 1 week ago
0 years
0 Lacs
Andhra Pradesh
On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description About Chromatography & Mass Spectrometry Division! From sample to knowledge to results, the Chromatography and Mass Spectrometry business develops and manufactures leading-edge chromatography and mass spectrometry instruments, consumables, and software solutions for customers working in the analytical sciences (routine testing markets) and scientific research. Our complete workflow solutions enable productivity and efficiency for customers performing food and beverage testing and manufacturing, environmental and industrial testing, biopharma QA/QC, toxicology, and anti-doping. For scientific research customers, our products support a range of focus areas, including proteomics, metabolomics, drug discovery and clinical research. Roles and Responsibilities: 1.Support Thermo Fisher customers through technical service, installation, operation, training and repair of specialized – Analytical equipment like Ion chromatograpy and have excellent technical competency if the HPLC product line. 2. Undertake product installation on client premises and demonstrate the features related to 21 CFR compliance. In the CDS software. 03.Provide training and technical advice on instrument use, both in person and by phone by sharing Dos and Don’ts for optimum performance of the system. 04.Investigate difficulties and solve faults arising from operation or utilization. 05. Rectify problems or suggest solutions or arrange for repairs to be made. 06.Provide an important link between customers and Sales and Marketing. 07. Provides a communication link between the customer and the company to help ensure that effective service is provided to the customer. 08. Monitor repairs in terms of the organization’s service / warranty cover and making suggestions as to product improvements. 09. Carry out planned maintenance calls and perform regular customer visits. 10. Make recommendations about spare parts requirement and assisting with monitoring equipment. 11.Achieve the assigned spares and Service revenue targets by prompting PM kits, instrument upgrade, software upgrades and calibration the systems. 12. Role requires extensive travelling within the territory and may call for travel outside territory if need arises Knowledge, Skills, abilities Candidate should have minimum 3 to 4 yrs experience in Analytical equipment like Ion chromatograpy and have excellent technical proficiency if the HPLC product line. 1. Bachelor of Technology (Biotechnology/ Electronics 2. Fluent written and verbal communication 3. Interpersonal skills suitable for a people-oriented job, requiring interactions with many people both inside and outside the organization 4. Ability to prioritize service requests and produce clear and concise documentation 5. Self-motivated and proactive in technical and support approach. 6. Closely work with customer in understanding customer pain areas and be consultant between organization and the customer thereby helping the customer and organization to achieve our regional commercial goals. 7. Build good rapport with customer and educate the customer reg. procurement of PM kits annually and reduce DT of the system.
Posted 1 week ago
0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials About Chromatography & Mass Spectrometry Division! From sample to knowledge to results, the Chromatography and Mass Spectrometry business develops and manufactures leading-edge chromatography and mass spectrometry instruments, consumables, and software solutions for customers working in the analytical sciences (routine testing markets) and scientific research. Our complete workflow solutions enable productivity and efficiency for customers performing food and beverage testing and manufacturing, environmental and industrial testing, biopharma QA/QC, toxicology, and anti-doping. For scientific research customers, our products support a range of focus areas, including proteomics, metabolomics, drug discovery and clinical research. Roles and Responsibilities: Support Thermo Fisher customers through technical service, installation, operation, training and repair of specialized – Analytical equipment like Ion chromatograpy and have excellent technical competency if the HPLC product line. Undertake product installation on client premises and demonstrate the features related to 21 CFR compliance. In the CDS software. Provide training and technical advice on instrument use, both in person and by phone by sharing Dos and Don’ts for optimum performance of the system. Investigate difficulties and solve faults arising from operation or utilization. Rectify problems or suggest solutions or arrange for repairs to be made. Provide an important link between customers and Sales and Marketing. Provides a communication link between the customer and the company to help ensure that effective service is provided to the customer. Monitor repairs in terms of the organization’s service / warranty cover and making suggestions as to product improvements. Carry out planned maintenance calls and perform regular customer visits. Make recommendations about spare parts requirement and assisting with monitoring equipment. Achieve the assigned spares and Service revenue targets by prompting PM kits, instrument upgrade, software upgrades and calibration the systems. Role requires extensive travelling within the territory and may call for travel outside territory if need arises Knowledge, Skills, Abilities Candidate should have minimum 3 to 4 yrs experience in Analytical equipment like Ion chromatograpy and have excellent technical proficiency if the HPLC product line. Bachelor of Technology (Biotechnology/ Electronics Fluent written and verbal communication Interpersonal skills suitable for a people-oriented job, requiring interactions with many people both inside and outside the organization Ability to prioritize service requests and produce clear and concise documentation Self-motivated and proactive in technical and support approach. Closely work with customer in understanding customer pain areas and be consultant between organization and the customer thereby helping the customer and organization to achieve our regional commercial goals. Build good rapport with customer and educate the customer reg. procurement of PM kits annually and reduce DT of the system.
Posted 1 week ago
0.0 - 5.0 years
2 - 9 Lacs
Sidhi
On-site
Institution: Divy Jyoti Pharmacy College, Sidhi Qualification: M.Pharm in Pharmacology Experience: 0–5 Years Job Type: Full-Time | Permanent Responsibilities: Teach topics like drug action, toxicology, and therapeutics to D.Pharm and B.Pharm students. Conduct lab work, including simulations or basic animal model theory (as per norms). Mentor students on pharmacological case studies and clinical relevance. Participate in departmental meetings, exam duties, and academic planning. Preferred Skills: Deep understanding of pharmacokinetics and pharmacodynamics Clear communication Additional familiarity with biology and patient counselling preferred Job Type: Full-time Pay: ₹20,000.00 - ₹80,000.00 per month Work Location: In person
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
You are looking for a Study Director - Toxicology position at Syngene in Bangalore. As a Study Director, you will be responsible for overseeing GLP toxicology studies in compliance with global regulatory guidelines. Your role will involve coordinating with cross-functional teams, conducting in-life phases of toxicology studies in various animals, administering doses, collecting blood samples, and ensuring adherence to safety protocols and SOPs. Key Responsibilities: - Serve as a Study Director for in vivo toxicology studies, ensuring scientific, technical, and regulatory compliance - Coordinate with local cross-functional teams for the execution of toxicology studies - Conduct in-life phases of toxicology studies in rats, mice, and rabbits, including dose administration and blood sample collection - Utilize the Pristima data capture system for study documentation - Assist in necropsy activities, blood collection, and electrophysiology studies - Prepare for and participate in IAEC meetings, maintaining necessary documentation - Follow in-house SOPs, coordinate instrument maintenance and calibration, and archive materials from toxicology studies - Perform any other duties assigned by the line manager Requirements: - Experience: 3-6 years in toxicology with a preference for candidates with contract research organization experience - Skills: Good understanding and hands-on experience in toxicology, knowledge of toxicokinetics, pathology, and analytical chemistry - Education: MVSc At Syngene, safety is a top priority, and all employees are expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment. The company values excellence, integrity, and professionalism, and expects all employees to demonstrate these core values consistently. If you meet the specified requirements and are passionate about toxicology, this role at Syngene could be a great fit for you. Join us in our commitment to innovation and scientific excellence in contract research, development, and manufacturing services.,
Posted 1 week ago
4.0 - 9.0 years
5 - 10 Lacs
Hyderabad
Work from Office
Greetings from Vivo Bio Tech Ltd! Job Responsibility: Study Director Job Title: Scientist/Senior Scientist Company: Vivo Bio Tech Ltd Location: Hyderabad Experience: 4-10 Years Education: Postgraduate (Life Sciences/Pharmacology/Toxicology or related fields) Vivo Bio Tech Ltd is seeking experienced Study Directors to lead and manage Preclinical studies in accordance with GLP and CRO regulatory guidelines . The role involves planning, execution, monitoring, and reporting of the experienced departments below: 1.Toxicology 2.Bio Analytical 3.Analytical Chemistry Job Requirements: Postgraduate degree in Life Sciences or related discipline. 4-10 years of relevant experience in Preclinical with CRO and GLP studies . Strong understanding of regulatory guidelines and data integrity practices. Excellent analytical, communication, and project management skills.
Posted 1 week ago
10.0 - 15.0 years
50 - 55 Lacs
Hyderabad
Work from Office
Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Our EHS Sustainability Enablement team is responsible for the safe, sustainable, and cost-effective construction, operation and maintenance of world-class facilities that enable the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases. EHS Sustainability Enablement Services engages the BMS global network to develop and deliver the corporate energy, water, and greenhouse gas sustainability goals while driving energy cost efficiencies and reliability enhancements through robust utilities strategies, initiatives, and operational innovations. Here, you ll get the chance to pursue innovative ideas, and advance professionally alongside some of the brightest minds in the industry. Position Summary This is an outstanding opportunity to join a growing and passionate team that is focused on being a world class Product Stewardship group within Bristol Myers Squibb s Environment, Health, Safety and Sustainability Enablement organization. As a member of the Product Stewardship group, the successful applicant will be primarily responsible for the development of a company-wide approach to perform GLP environmental fate/effects studies and environmental risk assessments according to appropriate international regulatory guidelines. This role will lead and participate on diverse multi-functional teams to deliver on-time and on-budget GLP studies and environmental risk assessments necessary to support successful clinical trials and drug registrations around the world. In addition to working on environmental risk assessments, the successful applicant will have the opportunity to participate in other aspects of the Product Stewardship program (e.g., global research projects, environmental support of sites, extended producer responsibility, chemical registrations, hazard communication). This role will also act as the primary back up for the program lead. Key Responsibilities Act as company subject matter expert on environmental risk assessments and environmental fate/effects studies focused on global regulatory frameworks, technical knowledge and emerging scientific trends; Lead matrix teams in the preparation of environmental risk assessments to support drug product registrations and chemical registrations worldwide Plan, monitor and evaluate external environmental fate and effects studies conducted according to Organization for Economic Co-operation and Development (OECD) guidelines and Good Laboratory Practice (GLP) requirements Monitor and anticipate technical/regulatory developments in environmental risk assessment practices and testing approaches Participate on industry trade group committees assessing the environmental relevance of Pharmaceuticals in the Environment and related topics Provide technical environmental support for chemical regulations ( e.g. , REACH, GHS/CLP) and site emission evaluations Qualifications Experience Ph.D. in toxicology or related discipline preferred ( e.g. , environmental science, environmental health, environmental fate); expertise in chemical fate is a plus; DABT certification (or similar) preferred, but not required Minimum 10 years of risk assessment or related experience in the pharmaceutical/biotech, chemical or pesticide industry; experience with genetically modified organisms is a plus Expertise with GLP regulations, environmental fate and effects studies and environmental risk assessment frameworks; modeling expertise is a plus Familiarity with chemical registration frameworks is a plus Demonstrated skills in the analysis of complex data and in the development of problem-solving strategies; ability to summarize complex data in a concise and audience-appropriate manner Passionate self-starter with the ability to lead and/or participate in diverse matrix teams in a global environment; experienced in project management and operational excellence mindset Strong communication and interpersonal skills and a demonstrated ability to influence senior management, third parties, thought leaders and regulatory agencies; acts with integrity Ability to innovate and encourages others to do so as well. Strives to enhance performance by doing things that are unique and leading edge; experience with AI and/or automation is a plus Willingly embraces changes needed to adapt to new circumstances and uncertainties The starting compensation for this job based in New Jersey is a range from $162,930 - $ 197,400, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #GPS_2025 With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Posted 2 weeks ago
3.0 - 6.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Date: 26 Jun 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Discovery Services Job Description Job title: Study Director - Toxicology Department : Safety Assessment Job location: Bangalore 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 Good understanding and hands on Experience of toxicology. Preferably have knowledge of related disciplines, toxicokinetics, pathology and analytical chemistry. Candidate working in or have relevant experience in contract research organization will be preferred. Education MVSc 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.
Posted 2 weeks ago
0.0 years
11 - 15 Lacs
Hyderabad
Work from Office
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Medicinal chemistry; Research and development; Literature search; Scifinder / Reaxys; Design and synthesis; combiflash/Biotage; C-C coupling etc Qualifications MSC - Organic Chemistry.
Posted 2 weeks ago
0.0 years
17 - 22 Lacs
Bengaluru
Work from Office
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Planning/performing and reporting of acute toxicology studies Assist in preparation of SOP"™s, Protocols and Reports Participate in GLP / AAALAC related activities Literature search Maintenance of animal house and relevant documents as per GLP and AAALAC norms. To Assist and work along with SD and TC in Planning, initiation and conduct studies. Test item administration, dose formulation preparation and blood collection. Assistance in data collection, compilation and verification. Participate in GLP inspections and ensure relevant regulatory compliance guidelines. Support in interpretation and reporting of study data. Assist in report preparation and coordination of activities. Assist in archiving of all study related materials. Skills Required: Understanding of the agrochemical and pharmaceutical R&D process Behavioral Competencies: Good in oral / written communication skills. If you're interested in applying or learning more, send your updated resume to [email protected] with the subject line "Research Scientist/Senior Research Scientist - Acute "“ Toxicology - Bangalore". Qualifications Qualification M.Sc. in Zoology/Biosciences Additional Information Specialization Toxicology Department Acute "“ Toxicology Experience (years) 2 to 8 only
Posted 2 weeks ago
0.0 years
7 - 12 Lacs
Hyderabad
Work from Office
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Department - Discovery Qualification - MSC - Organic Chmeistry Role - Trainee Mode - Internship Stipend - 16000 Location - Hyderabad Qualifications MSC - Organic Chemistry
Posted 2 weeks ago
10.0 years
0 Lacs
Hyderabad, Telangana, India
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Our EHS & Sustainability Enablement team is responsible for the safe, sustainable, and cost-effective construction, operation and maintenance of world-class facilities that enable the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases. EHS & Sustainability Enablement Services engages the BMS global network to develop and deliver the corporate energy, water, and greenhouse gas sustainability goals while driving energy cost efficiencies and reliability enhancements through robust utilities strategies, initiatives, and operational innovations. Here, you'll get the chance to pursue innovative ideas, and advance professionally alongside some of the brightest minds in the industry. Position Summary This is an outstanding opportunity to join a growing and passionate team that is focused on being a world class Product Stewardship group within Bristol Myers Squibb's Environment, Health, Safety and Sustainability Enablement organization. As a member of the Product Stewardship group, the successful applicant will be primarily responsible for the development of a company-wide approach to perform GLP environmental fate/effects studies and environmental risk assessments according to appropriate international regulatory guidelines. This role will lead and participate on diverse multi-functional teams to deliver on-time and on-budget GLP studies and environmental risk assessments necessary to support successful clinical trials and drug registrations around the world. In addition to working on environmental risk assessments, the successful applicant will have the opportunity to participate in other aspects of the Product Stewardship program (e.g., global research projects, environmental support of sites, extended producer responsibility, chemical registrations, hazard communication). This role will also act as the primary back up for the program lead. Key Responsibilities Act as company subject matter expert on environmental risk assessments and environmental fate/effects studies focused on global regulatory frameworks, technical knowledge and emerging scientific trends; Lead matrix teams in the preparation of environmental risk assessments to support drug product registrations and chemical registrations worldwide Plan, monitor and evaluate external environmental fate and effects studies conducted according to Organization for Economic Co-operation and Development (OECD) guidelines and Good Laboratory Practice (GLP) requirements Monitor and anticipate technical/regulatory developments in environmental risk assessment practices and testing approaches Participate on industry trade group committees assessing the environmental relevance of Pharmaceuticals in the Environment and related topics Provide technical environmental support for chemical regulations ( e.g. , REACH, GHS/CLP) and site emission evaluations Qualifications & Experience Ph.D. in toxicology or related discipline preferred ( e.g. , environmental science, environmental health, environmental fate); expertise in chemical fate is a plus; DABT certification (or similar) preferred, but not required Minimum 10 years of risk assessment or related experience in the pharmaceutical/biotech, chemical or pesticide industry; experience with genetically modified organisms is a plus Expertise with GLP regulations, environmental fate and effects studies and environmental risk assessment frameworks; modeling expertise is a plus Familiarity with chemical registration frameworks is a plus Demonstrated skills in the analysis of complex data and in the development of problem-solving strategies; ability to summarize complex data in a concise and audience-appropriate manner Passionate self-starter with the ability to lead and/or participate in diverse matrix teams in a global environment; experienced in project management and operational excellence mindset Strong communication and interpersonal skills and a demonstrated ability to influence senior management, third parties, thought leaders and regulatory agencies; acts with integrity Ability to innovate and encourages others to do so as well. Strives to enhance performance by doing things that are unique and leading edge; experience with AI and/or automation is a plus Willingly embraces changes needed to adapt to new circumstances and uncertainties The starting compensation for this job based in New Jersey is a range from $162,930 - $ 197,400, plus incentive cash and stock opportunities (based on eligibility). The starting compensation for this job based in Massachusetts is a range from $179,220 - $ 217,200, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2 weeks ago
5.0 - 10.0 years
5 - 15 Lacs
Hyderabad
Work from Office
Dear All, Greetings from Vivo Bio Tech Limited! Job Description: Business Development (BD) role** in a CRO setting Experience: 3+ Job Title:** Business Development Manager Preclinical Services Location:** Hyderabad Reports To:** Head – Business Development / Executive Director Job Overview: We are seeking a proactive and results-driven **Business Development Manager** to independently drive lead generation and conversion across domestic and international markets. The ideal candidate should have strong networking skills within the **CRO industry**, and proven experience in securing business from **Pharma, Agrochemicals, Industrial Chemicals, Vaccines, Generics, and Medical Devices** clients. This role requires working knowledge of **GLP compliance**, **regulatory affairs**, **toxicology studies**, and familiarity with submission processes to global regulatory bodies. Key Responsibilities:** * Independently generate, qualify, and convert leads for preclinical research services. * Submit tailored technical and commercial quotations to potential clients. * Network extensively across Pharma, Agrochemical, Vaccine, Generic Drug, Medical Device, and Chemical industries. * Understand client requirements and align them with organizational capabilities in **GLP and non-GLP studies**. * Develop and maintain strong client relationships to drive repeat and long-term business. * Coordinate with internal scientific and operational teams to design study proposals and timelines. * Provide market intelligence and competitor analysis to support strategic planning. * Track, monitor, and support **regulatory submissions** to international authorities such as USFDA, EMA, WHO, PMDA, ANVISA, etc. * Stay updated with global guidelines relevant to **Mammalian Toxicology**, **Ecotoxicology**, and **Regulatory Submissions**. * Promote services across **small and large animal studies**, including rodent, canine, minipig, and non-human primate models. * Collaborate on proposals for government and international grants or tenders (if applicable). Key Requirements:** * Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related fields. * Minimum 2–15 years of BD experience in a CRO or related preclinical research setting. * Strong understanding of **GLP requirements** and study types. * Working knowledge of **toxicology, pharmacology, ecotoxicology**, and **regulatory pathways**. * Familiarity with **GTC (General Toxicity Category)** studies and their scope. * Excellent communication, negotiation, and relationship-building skills. * Self-motivated and target-oriented with strong business acumen. * Willingness to travel domestically and internationally as required. --- Preferred Experience: * Exposure to **OECD, ICH, USFDA, EPA, REACH, and other regulatory guidelines**. * Experience in handling **multi-national clients** and long-term contracts. Vivo Bio Tech Ltd Survey # 349/A, Pregnapur Village, Gajwel Mandal. Siddipet District, PIN 502311,Telangana, India. Regards, Chandra Kanth | HRD chandrakanth.k@virinchi.com
Posted 2 weeks ago
0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Job Title: Associate Director, Alliance Management Global Career Level: E Introduction to role Are you ready to be part of a mission that accelerates the speed, increases the efficacy, and improves the safety of medicines for patients? Join us in a place where innovation and creativity thrive, and diverse perspectives are welcomed and valued. We champion inclusion and diversity, reflecting the communities we serve. Be part of a multi-disciplinary team driving groundbreaking innovation and contribute meaningfully to achieving our ambitious goals within an inspiring, collaborative, and entrepreneurial culture. Accountabilities This is an exciting opportunity to support strategic partnerships with global Contract Research Organizations (CROs). As an Associate Director - Alliance Management, you will play a foundational role in the successful delivery of studies conducted through our CRO partnerships. Establish strategic objectives with CROs, develop Key Performance Indicators (KPIs), evaluate and mitigate outsourcing risks, and seek opportunities for improvement. Your efforts ensure our medicines reach millions of patients faster than ever! What You Will Do Lead our strategic alliances with CRO and Academic partners who conduct Discovery, DMPK, Toxicology and Bioanalytical studies on our behalf, including lead for the local networking ecosystem. Represent Alliance Management at Executive Steering Committee (ESC) meetings. Appropriately escalate issues that have not been resolved at the Operational level to executive sponsors when needed. Develop the operational model for new alliances, integrating tasks and activities into your day-to-day responsibilities. Lead preparation and execution of Third-Party Risk Management, Transfer Impact Assessments, and Privacy Impact Assessments for new partnerships, and renew assessments as needed for ongoing partnerships. Support due diligence for new partnerships or business opportunities. Responsible for updating and maintaining alliance management processes and tools, and for measuring and reporting on the success of alliances on a regular basis. Champion a collaborative “one team” culture across internal and external teams. Develop and evolve strategic alliances to align with our company goals - find opportunities for collaborative value generation including expansion of partnerships, and mitigation of risks. Conduct regular governance meetings with strategic partners and internal stakeholders to assess progress against plans. Essential Skills/Experience Bachelor’s degree or higher in relevant discipline Demonstrated ability in Alliance Management of global, strategic drug discovery relationships Previous Contract Research Organization experience Understanding of contracts and ability to interpret contractual responsibilities of both parties Understanding of the process of drug discovery and development Excellent communication and interpersonal skills Ability to influence without authority Experience in Discovery or Preclinical drug development Desirable Skills/Experience Strong background/experience in DMPK, Discovery or Toxicology Contract Research Organisation (CRO) experience highly preferred Project management experience CA-AM Certification When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, scientific leadership transforms patients' lives. We push the boundaries of science to deliver life-changing medicines for complex diseases. With a groundbreaking pipeline, we strive to understand diverse populations' needs and transform healthcare for a future where everyone can access affordable, sustainable, innovative healthcare. Join us as we pioneer the next wave of science and therapeutics. Ready to make a difference? Apply now and be part of our journey to transform healthcare! Date Posted 14-Jul-2025 Closing Date 31-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Posted 2 weeks ago
0 years
0 Lacs
Vadodara, Gujarat, India
On-site
Histopathology evaluation and report preparation of pharmacology studies Planning, designing and monitoring of GLP/Non -GLP toxicity studies in rodent and non-rodent Scientific data collection, interpretation of toxicology data and study report preparation/review.
Posted 2 weeks ago
0 years
0 Lacs
Gorakhpur, Uttar Pradesh, India
On-site
We are hirring MBBS/ MD Anesthesilogist @ Gorakhpur (Kushinagar) Uttar Pradesh location .. Details are as follow ** MBBS (Anesthesia)** ** MD (Anesthesia)** **DNB/DM Nephrology** Required Candidate profile If you are interested so pls share me your resume on my WhatsApp - 9557944966 with the following details - Ctc Ectc Current location Notice period Mic Registration Comfortable for Gorakhpur (Khushinagar) location Role: Medical Officer Industry Type: Medical Services / Hospital Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Doctor Education UG: MBBS in Any Specialization PG: Medical-MS/MD in Anesthesiology, Forensic Medicine/Forensic Medicine & Toxicology, Nephrology Key Skills Skills highlighted with ‘‘ are preferred key skills: Nephrology Anesthesia, MD Medicine Anesthesiologist MBBS Anesthesia General Medicine Internal Medicine DNB Anesthesiology
Posted 2 weeks ago
4.0 - 8.0 years
0 Lacs
karnataka
On-site
You will be part of a leading expert organization specializing in assurance and risk management. With a commitment to safeguarding life, property, and the environment, you will play a crucial role in empowering customers and stakeholders with reliable insights to make confident decisions. Being a trusted entity for top global organizations, your expertise will contribute to advancing safety and performance, setting industry benchmarks, and innovating solutions to address global challenges. Your responsibilities will involve conducting audits and assessments related to In-Vitro Diagnostic Medical Devices. As an Assessor, you will perform assessments according to established procedures, ensure effective customer communication, and review Technical Files for specific products. Your role will also include completing projects related to IVDR procedures and making certification decisions within stipulated timeframes. In the role of an Auditor, you will be responsible for auditing manufacturers" quality management systems and suppliers/subcontractors when necessary. Conducting surveillance audits, maintaining strong customer relationships, and managing auditing teams efficiently will be key aspects of your job. Additionally, you will undertake projects related to IVDR procedures and contribute to certification recommendations within defined timelines. Required qualifications for Assessors and Auditors include a technical college degree in relevant areas such as Biology, Chemistry, Medical Technology, Human Physiology, Nursing, or related fields. Candidates must possess a minimum of 4 years of full-time work experience in the In-Vitro diagnostic medical device industry, academia, or hospital settings, with at least 2 years focused on device design, manufacturing, testing, or usage. Practical experience in quality management systems, production processes, and performance evaluation data related to In-Vitro diagnostic medical devices is essential. Preferred qualifications include a strong understanding of medical device management systems, standards, compliance auditing techniques, and risk management practices. Experience with Harmonized medical device standards, EN ISO 14971, and technical writing skills are advantageous for this role. Candidates with a Ph.D. in a relevant field related to in-vitro diagnostic medical devices may substitute work experience requirements with appropriate expertise. In addition to competitive compensation, you will enjoy flexible work arrangements, generous paid leaves, medical benefits, pension schemes, training assistance, and various additional benefits. The company values work-life balance, career development, and employee well-being, offering a supportive and rewarding work environment. Join us in our mission to drive trust, transparency, and sustainable results in the assurance industry, contributing to global transformations and making a positive impact on society.,
Posted 2 weeks ago
0 years
0 Lacs
Sarita Vihar, Delhi, India
On-site
Overview Role: Senior Consultant (REACH Lead) Location: India, New Delhi - Hybrid - 3 days minimum a week in the office. Role ID: 2025-2687 Our vision is to create a safe and sustainable world We are looking for an experienced chemical regulatory affairs professional with the skills to work in our REACH consultancy business in ourNew Delhi office in India. You will be required to work in the office for a minimum of 3 days a week. This is an exciting opportunity for someone with a broad skill set including technical, project management and commercial development skills looking to take a career step either into or within consultancy. You will help to lead a successful team and continue Ricardo’s strong growth trajectory as the world implements more regulations to safely manage chemicals. This is an ideal role for someone who wants to take ownership for a high growth potential product area, make their mark and drive significant business performance. As a Senior REACH Consultant your main responsibilities will be: Using your extensive technical knowledge to oversee and to contribute to the delivery of client work at the project manager or project lead level including contributing with your own specialisms as needed. Proactively managing projects and customers allowing you to deliver excellence and win repeat business. Supporting our client relationships and the account management team by joining key customer discussions and identifying new areas of opportunity with the client. Liaising with marketing and sales staff to ensure effective promotion of Ricardo’s REACH capabilities in support of sales activities, identifying opportunities for growth and contributing to the development of effective marketing strategy with the Sales Director. Supporting wider market outreach, including presenting at conferences, building and engaging with a personal network, and positioning Ricardo as a strategic partner externally. Collaborating and identifying strategic opportunities for new products and services with other Ricardo business areas including our environmental chemistry and toxicology, chemicals policy, agriculture and water teams on a global basis. Keeping up to date with market trends and developments. Coaching and knowledge sharing with team members, helping others to grow their knowledge of the REACH regulation and how it applies to clients. Key Skills And Experience Excellent knowledge of the UK and European chemical regulatory landscape with specific specialism in EU and UK REACH, and in emerging European policy. Hands-on experience with all aspects of REACH registration including data gap analysis, study design and monitoring, dossier preparation in IUCLID and making submissions through REACH-IT, managing project costs, working with stakeholder groups and regulators. Performing and managing high quality technical projects in the field of chemical regulatory affairs and effective delegation of work. Excellent communication skills, used to presenting your ideas and project outputs to internal stakeholders, customers and at regulatory conferences, at events or through webinars, blogs etc. Contributing to the development and implementation of a business strategy with respect to chemical regulation. A supportive colleague and coach who enables the team to successfully deliver regulatory consultancy projects and supports personal development of colleagues and clients as needed. Bringing your own network of contacts from customers and stakeholder organisations would be a benefit but not essential – candidates from consultant, industry and regulator positions are welcome. Experience in global chemical substance registration or other regulatory sectors (e.g., biocides, food, cosmetics etc) would be a benefit but is not essential. Working here Ricardo is an exciting and rewarding place to work and you have the opportunity to make a difference. You will work with teams of talented, dedicated, and supportive individuals. Alongside having a fantastic opportunity to develop your career with us through our broad range of projects, mentoring opportunities and a personalised approach to your learning and development. We are always keen to hear from people who have driven, ambition and a flair for innovative thinking. Wellbeing and work life balance We offer flexible approaches to work, whether that's working from home, being in the office, or as a hybrid worker. We're happy to discuss flexible working arrangements. Wellbeing is at the core to our culture, allowing employees to flourish and to achieve their full potential. Our People are important to us, and we take pride in our wellbeing programmes and policies that support individuals including flexible working, carers policy, mental health first aiders and readily available support through our extensive Employee Assistance programme. Diversity, Equality and Inclusion statement We are an Equal Opportunity Employer, we believe in each person's potential, and we'll help you reach yours. We have an ambitious diversity, equality, and inclusion approach as explained here. We value diversity; recognising that a more diverse workforce creates a richer and more varied working environment. Diversity also drives innovation, by allowing us to offer our clients the best consultancy service that we can. As part of our commitment to engage positively and pro-actively with all our employees and ensure a culture of inclusivity, we are a recognised as a 'disability confident' employer. Benefits Our core benefits include 25 days' annual leave, plus 8 flexible bank holidays, a competitive company pension scheme, life assurance and professional subscriptions reimbursement. We also offer a wide range of flexible benefits to suit your lifestyle. Next Steps Once you have submitted your application a member of our Recruitment Team will be in touch. Please be aware that the timing can vary dependent on the volume of applications that we receive for each role and in some cases, we may start to review applications prior to the closing date. Ricardo is a Disability confident employer - please advise the recruitment team viarecruit.ee@ricardo.comif you require any adjustments to support you throughout the recruitment process.
Posted 2 weeks ago
6.0 - 10.0 years
15 - 16 Lacs
Gurugram
Work from Office
Position: Toxicologist Educational qualification: M. Pharm, (specialization in Toxicology), M. Sc. in Biochemistry /Microbiology/Toxicology, B. V. Sc /M. V. Sc or any other equivalent qualification Experience: 6-10 years Desirable: Experience of conducting animal toxicology studies (Genotoxicity studies, Repeat dose general toxicity studies etc. ) Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Job Description: Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Risk assessment of process and degradation impurities, residual solvents etc. and to determine safe limit. Safety evaluation for various excipients used in formulations and to determine safe limit. Assessment of Extractables and Leachables. Genotoxicity hazard assessment of starting materials, raw materials, intermediates, residual solvents, degradation products etc using (QSAR) softwares [according to ICH M7] Toxicological evaluation of out of specification (OOS) of drug products for health hazard evaluation (HHE). Environmental risk assessment (ERA) of drug products. Assessment of nitrosamine impurities. Active collaboration with cross-functional teams (CFTs). Monitoring of out sourced non-clinical studies. Other tasks, as directed by the manager(s) or determined during the annual objectives setting process.
Posted 2 weeks ago
6.0 - 10.0 years
2 - 9 Lacs
Gurgaon
On-site
Title: Manager - DSE Date: Jul 14, 2025 Location: Gurgaon - R&D Company: Sun Pharmaceutical Industries Ltd Position: Toxicologist Educational qualification: M. Pharm, (specialization in Toxicology), M. Sc. in Biochemistry /Microbiology/Toxicology, B.V.Sc /M.V.Sc or any other equivalent qualification Experience: 6-10 years Desirable: Experience of conducting animal toxicology studies (Genotoxicity studies, Repeat dose general toxicity studies etc.) Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Job Description: Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Risk assessment of process and degradation impurities, residual solvents etc. and to determine safe limit. Safety evaluation for various excipients used in formulations and to determine safe limit. Assessment of Extractables and Leachables. Genotoxicity hazard assessment of starting materials, raw materials, intermediates, residual solvents, degradation products etc using (QSAR) softwares [according to ICH M7] Toxicological evaluation of out of specification (OOS) of drug products for health hazard evaluation (HHE). Environmental risk assessment (ERA) of drug products. Assessment of nitrosamine impurities. Active collaboration with cross-functional teams (CFTs). Monitoring of out sourced non-clinical studies. Other tasks, as directed by the manager(s) or determined during the annual objectives setting process.
Posted 2 weeks ago
6.0 - 10.0 years
0 Lacs
Gurgaon, Haryana, India
On-site
Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager - DSE Date: Jul 14, 2025 Location: Gurgaon - R&D Company: Sun Pharmaceutical Industries Ltd Position: Toxicologist Educational qualification: M. Pharm, (specialization in Toxicology), M. Sc. in Biochemistry /Microbiology/Toxicology, B.V.Sc /M.V.Sc or any other equivalent qualification Experience: 6-10 years Desirable: Experience of conducting animal toxicology studies (Genotoxicity studies, Repeat dose general toxicity studies etc.) Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Job Description: Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Risk assessment of process and degradation impurities, residual solvents etc. and to determine safe limit. Safety evaluation for various excipients used in formulations and to determine safe limit. Assessment of Extractables and Leachables. Genotoxicity hazard assessment of starting materials, raw materials, intermediates, residual solvents, degradation products etc using (QSAR) softwares [according to ICH M7] Toxicological evaluation of out of specification (OOS) of drug products for health hazard evaluation (HHE). Environmental risk assessment (ERA) of drug products. Assessment of nitrosamine impurities. Active collaboration with cross-functional teams (CFTs). Monitoring of out sourced non-clinical studies. Other tasks, as directed by the manager(s) or determined during the annual objectives setting process. Apply Now » Apply Now Start applying with LinkedIn Please wait...
Posted 2 weeks ago
6.0 - 10.0 years
0 Lacs
Gurgaon, Haryana, India
On-site
Position: Toxicologist Educational qualification: M. Pharm, (specialization in Toxicology), M. Sc. in Biochemistry /Microbiology/Toxicology, B.V.Sc /M.V.Sc or any other equivalent qualification Experience: 6-10 years Desirable Experience of conducting animal toxicology studies (Genotoxicity studies, Repeat dose general toxicity studies etc.) Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Job Description Determination of health based exposure limit (OEL and PDE). Preparation of non-clinical dossier (as per CTD modules) for regulatory submission Risk assessment of process and degradation impurities, residual solvents etc. and to determine safe limit. Safety evaluation for various excipients used in formulations and to determine safe limit. Assessment of Extractables and Leachables. Genotoxicity hazard assessment of starting materials, raw materials, intermediates, residual solvents, degradation products etc using (QSAR) softwares [according to ICH M7] Toxicological evaluation of out of specification (OOS) of drug products for health hazard evaluation (HHE). Environmental risk assessment(ERA) of drug products. Assessment of nitrosamine impurities. Active collaboration with cross-functional teams (CFTs). Monitoring of out sourced non-clinical studies. Other tasks, as directed by the manager(s) or determined during the annual objectives setting process.
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
You will be responsible for supporting regulatory and safety assessment services as an Expert in PDE (Permitted Daily Exposure), OEL (Occupational Exposure Limit), and QSAR (Quantitative Structure-Activity Relationship) Assessment. Your strong background in Pharmacology or Toxicology will be essential for preparing PDE/OEL reports and conducting QSAR assessments. Your responsibilities will include preparing PDE/OEL reports in accordance with regulatory guidelines, conducting QSAR assessments to evaluate chemical risks, collaborating with cross-functional teams to ensure compliance, analyzing and interpreting toxicology and exposure data, and staying updated with industry best practices and regulatory guidelines. To qualify for this role, you should have an MSc/PhD in Pharmacology or Toxicology, 2-5 years of relevant experience in PDE/OEL and QSAR assessments, a strong knowledge of toxicological risk assessment methodologies, experience with regulatory requirements related to exposure limits, and excellent analytical and problem-solving skills.,
Posted 2 weeks ago
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