82 Pharmacokinetics Jobs

Roles in DMPK we are hiring for : Bioanalytical / Peptides, Antibody drug conjugates and ASOs In vitro ADME / cell biology, cell permeability hepatocytes, 3D cultures, image analysis, drug transporters and enzymology PK/PD, Modeling and Simulations / Pheonix WinNonlin, R, Monolix, NONMEM, MATLAB, or any other custom-built software In vitro Toxicology/ 3D cultures-Organoids and Spheroids Key Responsibilities : Knowledge of data compilation and interpretation for test compound classification systems, either as substrates or uptake inhibitors. Ability to understand and read data, identify data variability, and participate in data review cycles with the QA team. Commitment to delivering data within agreed timelines (Less 7 days) and strong work ethics to complete assigned tasks. Excellent communication and collaboration skills, working closely with team members. Good oral and written communication skills. Education and Experience: M Pharm (Pharmacology/Pharmaceutics) with 3-8 years of experience or MSc with 6-8+ years of experience in DMPK of small molecule drug discovery and development, preferably in a CRO or Biotech/Pharma industry. Knowledge of FDA and EMA industry guidance

Department: DMPK (Drug Metabolism and Pharmacokinetics) Location: Hyderabad About Sai: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Roles in DMPK we are hiring for : Bioanalytical / Peptides, Antibody drug conjugates and ASOs In vitro ADME / cell biology, cell permeability hepatocytes, 3D cultures, image analysis, drug transporters and enzymology PK/PD, Modeling and Simulations / Pheonix WinNonlin, R, Monolix, NONMEM, MATLAB, or any other custom-built software In vitro Toxicology/ 3D cultures-Organoids and Spheroids Key Responsibilities : To work on Drug Discovery project providing DMPK support. Knowledge of data compilation and interpretation for test compound classification systems, either as substrates or uptake inhibitors. Ability to understand and read data, identify data variability, and participate in data review cycles with the QA team. Commitment to delivering data within agreed timelines (< 7 days) and strong work ethics to complete assigned tasks. Excellent communication and collaboration skills, working closely with team members. Good oral and written communication skills. Education and Experience: M Pharm (Pharmacology/Pharmaceutics) with 3-8 years of experience or MSc with 6-8+ years of experience in DMPK of small molecule drug discovery and development, preferably in a CRO or Biotech/Pharma industry. Knowledge of FDA and EMA industry guidance.

As an In vitro Bioanalytical Scientist at Syngene, based in Hyderabad, you will be responsible for participating in sample processing for PK and ADME assays, as well as handling LCMS/MS. Your role will involve adapting to a dynamic team environment, processing various matrices samples for PK studies, optimizing test compounds manually and automated on LCMS/MS, and independently handling HPLC for UV-based sample analysis. Additionally, you will be expected to develop methods with the team lead, document lab notebooks online, and manage compounds effectively. You will need to demonstrate expertise in column selection, mobile phase selection, solvent preparations, and sample processing techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction. It is essential to have experience in handling ADME assays and HPLC and LCMS/MS, with a minimum of 3-5 years of relevant experience. Moreover, you should be capable of developing and validating LC-MS based qualitative/quantitative methods, conducting internet-based literature searches, and interpreting Mass/UV Spectra. As a part of the Syngene team, it is mandatory to adhere to safety guidelines, procedures, and SOPs, ensuring the safety of yourself, teams, and the lab/plant at all times. You must also complete all assigned mandatory trainings related to data integrity, health, and safety measures promptly. Furthermore, you will be expected to comply with Syngene's quality standards, hold yourself and your teams accountable for safety goals, and review safety metrics periodically. Syngene values excellence, integrity, and professionalism, and expects all employees to consistently demonstrate alignment with these core values. As a leader at Syngene, you will champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices, foster a corporate culture promoting an EHSS mindset, and uphold the highest standards of quality, integrity, and compliance. The ideal candidate for this role should possess a M. Pharm in Pharmaceutical Sciences or Pharmaceutical Analysis with a passion for LC/MS related bioanalysis. You should have a general understanding of drug metabolism and pharmacokinetics, be able to deliver scientific presentations, and write official project reports. Additionally, you should ensure preventative maintenance and calibration schedules of HPLC and mass spec by coordinating with vendors and support staff. Syngene is an equal opportunity employer, committed to providing integrated scientific services from early discovery to commercial supply, with safety as a top priority in all aspects of operations.,

Job Title: Associate Professor / Professor - Pharmacology / Pharmaceutics Location: K.R. Mangalam University, Haryana Department : School of Medical and Allied Sciences (Pharmacy) Employment Type: Full-time Job Summary: K.R. Mangalam University is looking for a highly qualified Professor in Pharmacology /Pharmaceutics to lead academic and research activities in the School of Medical and Allied Sciences. The candidate will be responsible for teaching, research, curriculum development, and industry collaboration while mentoring students and faculty members. Key Responsibilities: Teaching & Academics: Deliver lectures, tutorials, and practical sessions in Pharmacology /Pharmaceutics and related subjects at undergraduate and postgraduate levels. Develop and update course curricula in line with PCI, UGC, and NEP 2020 guidelines. Guide students in research projects, dissertations, and internships. Evaluate students through exams, assignments, and practical assessments. Research & Publications: Conduct advanced research in pharmacokinetics, pharmacodynamics, drug interactions, and clinical pharmacology / Pharmaceutics. Publish high-quality research papers in indexed journals (SCI, Scopus, PubMed, etc.). Secure research grants from national and international funding agencies. Mentor Ph.D. scholars and postgraduate students in research. Industry Collaboration & Innovation: Establish collaborations with pharmaceutical companies, clinical research organizations, and hospitals. Encourage patent filings, consultancy projects, and technology transfer. Organize seminars, workshops, and guest lectures on emerging trends in pharmacology /Pharmaceutics. Academic Leadership & Mentorship: Lead curriculum development and accreditation processes such as NAAC, NBA, and NIRF. Supervise faculty development programs and promote innovative teaching methodologies. Mentor students in career development, industry placements, and higher education opportunities. Participate in departmental and university-level academic committees. Eligibility Criteria: Educational Qualification: Ph.D. in Pharmacology / Pharmaceutics (Mandatory). Bachelor’s and Master’s degrees in Pharmacy (B.Pharm & M.Pharm) from PCI-approved institutions. Experience: 8+ years of teaching and research experience in Pharmacology / Pharmaceutics. Significant contributions to research, publications, and industry collaborations. Skills & Competencies: Expertise in pharmacological research, clinical trials, and drug development. Strong publication record in indexed journals and active participation in conferences. Leadership skills in academic administration, faculty mentoring, and curriculum development. Familiarity with modern teaching methods, e-learning platforms, and laboratory technologies. Interested Candidates can visit our website and they can send the resume on this mail id: K. R. Mangalam University Website - https://www.krmangalam.edu.in/careers/ Email ID - krmujobs@krmangalam.edu.in

You will be responsible for providing drug metabolism and pharmacokinetic support for discovery programs. Your main duties will include monitoring Pharmacokinetics studies, supporting bioanalysis, and offering pre-clinical ADME lead optimization support to small molecule Drug Discovery programs across various therapeutic areas. You will be working as a DMPK subject matter lead in multidisciplinary/cross-functional teams to understand the Chemical Structure ADME relationships and design appropriate strategies to enhance the Drug like Properties of the New Chemical Entities. To be successful in this role, you should have 2-5 years of experience in GLP with either an M.Sc. or Ph.D. degree. You should possess expertise in Bioanalysis using LC-MS/MS in both GLP and non-GLP environments. Additionally, you should be capable of leading projects as a DMPK representative, quantifying small molecules using LC-MS/MS, and conducting metabolite identification work on High-resolution mass spectrometry. Qualifications required for this position include an M. Pharm (Pharmacology / Pharmaceutical Analysis) or an M.Sc. (Biochemistry / Pharmaceutical Chemistry).,

Job Summary – Clinical Research (Micro Labs) Overview: Responsible for independently planning, executing, and managing clinical trials—mainly bioequivalence, but also safety and efficacy studies—ensuring they are completed on time, within budget, and in compliance with regulatory and company standards. Key Responsibilities: Contribute to formulation development. Define clinical strategy (Study designs, Sample size, healthy volunteers or patient studies). Lead and manage BABE studies from planning through execution, data analysis, and reporting. Collaborate closely with team leaders and oversee operational activities. Select and manage CROs, ensuring cost-efficiency, regulatory compliance, and quality. Ensure GCP audit readiness. Work Experience: Minimum 5-7+ years of experience in clinical Research (BABE studies) or associated fields. Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or IVIVC. Solid knowledge of GCP and worldwide regulatory requirements related to assigned area. Solid medical/scientific writing skills.

As a Senior R Developer at MResult, you will play a crucial role in supporting the development, validation, and deployment of models and tools used in drug development and clinical research. Your responsibilities will include developing and maintaining R scripts, packages, and Shiny applications for data analysis and visualization. You will be involved in performing statistical analysis and data manipulation related to clinical trials and PK/PD data. Collaboration with pharmacometricians and clinical scientists will be key as you work together to develop PK models and support modeling workflows. Automating data cleaning, processing, and reporting tasks will be part of your daily activities. You will also integrate PK/PD datasets with clinical trial data and prepare analysis-ready datasets. Ensuring code validation and documentation as per regulatory compliance standards such as FDA and EMA will be essential. In addition to technical responsibilities, you will generate reports and graphical outputs using tools like R Markdown and participate in cross-functional project teams, providing input on statistical and modeling strategies. To succeed in this role, you should have a Bachelor's or Masters degree in Statistics, Data Science, Bioinformatics, Pharmacology, or a related field and a minimum of 5 years of experience in R programming. Experience with R package development, version control using Git/GitHub, and hands-on experience in Pharmacokinetics (PK) is required, preferably in a clinical or pharmaceutical setting. A strong understanding of PK/PD concepts, NONMEM outputs, and model diagnostics will be beneficial. Excellent problem-solving skills, the ability to communicate complex results to non-technical stakeholders, attention to detail, and a commitment to code quality and reproducibility are essential qualities for success in this role. At MResult, you will have the opportunity to work with some of the world's most recognized brands, access growth opportunities, and contribute to cutting-edge solutions while enjoying the flexibility of hybrid work models. As an equal-opportunity employer, MResult is committed to fostering an inclusive environment free of discrimination and harassment. Join us at MResult, where your ideas help shape the future.,

Date: 23 Jul 2025 Location: Kolthur Shamirpet, Medchal, TG, IN, 500078 Custom Field 1: Discovery Services Job Title: Invitro Bioanalytical Scientist Job Location: Hyderabad 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  To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment  Processing of different matrices samples of PK studies  Optimization of test compounds manually as well as automated on LCMS/MS  Develop methods with the team lead  Independently handling of HPLC for UV based samples analysis.  Documenting the lab note books online and compound management Role Accountabilities Leadership Capabilities Syngene Values All employees will consistently demonstrate alignment with our core values  Excellence  Integrity  Professionalism Accountabilities as a Syngene Leader (only for Leadership Hires)  Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.  Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.  Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific requirements for this role Experience Demonstrated Capability Education Experience  Minimum 3-5 years of experience in handling ADME assays and HPLC and LCMS/MS Skills And Capabilities  Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory  Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods  Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis  Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required  Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra  Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff  General understanding of Drug metabolism and Pharmacokinetics  Should be able to deliver scientific presentation in departmental journal club and write official Project reports Education  M. Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis 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 accommodation for qualified individuals with disabilities.

Job Description: Toxicologist / Preclinical Scientist We are seeking a skilled Toxicologist / Preclinical Scientist to join our team. The ideal candidate will be accountable for conducting toxicological risk assessments and overseeing preclinical experimental research. 1. Key Responsibilities: Toxicological Risk Assessments • Derive Health-based Exposure Limits & support occupational hazard assessment (PDE/OEL) for pharmaceutical molecules in adherence to regulatory standards. • Conduct Toxicological Risk Assessments (TRA) for pharmaceuticals, excipients, intermediates, chemicals, cleaning agents, residual solvents, elemental impurities, and degradation products. • Perform Genotoxicity Hazard Assessments for impurities using published or experimental in-vitro/in-vivo data and in-silico (Q)SAR tools according to ICH M7 guidelines. • Evaluate extractable and leachable impurities using literature review and in-silico tools. • Determine Harmful Doses for children to guide selection of blister packaging. 2. Key Responsibilities: Experimental Toxicology & Preclinical Research • Develop preclinical strategies supporting differentiated product development. • Plan, outsource, oversee, and interpret in vitro and in vivo preclinical toxicology and pharmacokinetics/pharmacodynamics (PK/PD) studies for complex/differentiated products and impurity qualifications. • Plan, outsource, oversee, and interpret in vivo/ in vitro biocompatibility studies for medical devices. • Plan, outsource, oversee, and interpret in vitro immunogenicity studies for peptides and biosimilar products. • Summarize toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory authority submissions. Qualifications and Skills • Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field. • Minimum 3-5 years of experience in toxicological risk assessment & experimental toxicology within the pharmaceutical, CRO or biotechnology industry. • Strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions. • Proven ability to manage multiple projects simultaneously and work effectively in a dynamic team environment. • Excellent communication skills with the ability to collaborate cross-functionally and interact with external partners such as CROs. • Detail-oriented with proactive planning abilities, coupled with strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills. • Skilled in using computer software including Microsoft Office suite (Word, Excel, PowerPoint), SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications. Operational details: • Location: Vikhroli, Mumbai. • Mode: Full time, work from office • Shifts: General shift (8 hours) • Travelling: Rare/Occasional for outdoor duties/ monitoring

The candidate will undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion of the training, they will be placed for full-time patent analysis in the pharmaceutical domain. Required Candidate profile Scientific and Analytical Thinking Eager to work in drugs and formulation Candidates must have sound knowledge about the subjects they study in Graduation

Role & responsibilities Experience Minimum 3-5 years of experience in handling ADME assays and HPLC and LCMS/MS Skills and Capabilities Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff General understanding of Drug metabolism and Pharmacokinetics Should be able to deliver scientific presentation in departmental journal club and write official Project reports Preferred candidate profile M. Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis.

As a Senior Scientist in Clinical PBPK Modeling at AstraZeneca, located in Bengaluru, Karnataka, India, you will play a crucial role in advancing clinical drug development through the application of innovative and quantitative approaches. Your primary responsibility will involve utilizing physiologically-based pharmacokinetic (PBPK) and translational modeling tools to facilitate clinical PK projections for drug-drug interactions (DDIs), pediatric and specific populations, and other critical clinical development inquiries. Collaboration with Drug Metabolism and Pharmacokinetic (DMPK) Scientists, as well as Clinical Pharmacology scientists, will be key in generating mechanistic models. Your expertise will be pivotal in validating these models to a level suitable for Regulatory submissions and influencing the design of clinical trials. Furthermore, effective communication internally and externally on topics related to PBPK clinical DDI, pediatric, and other specific populations predictions will be essential. To excel in this role, you should possess knowledge of pharmacokinetics, Model-Informed Drug Development (MIDD), and have demonstrated experience in translational development, preferably with 0-4 years of drug development experience focusing on PBPK modeling. Additionally, familiarity with pharmacology, drug targets, and core disease areas is required. A Ph.D. degree or equivalent (M.Sc./Pharm.D.) with relevant experience is preferred. Proficiency in spoken and written English, along with training and experience in PBPK and relevant software such as SimCYP, GastroPlus, PK-Sim, and Phoenix WinNonlin, is necessary. Desirable skills include a strong scientific publishing reputation in the field of DMPK/Clinical Pharmacology and experience in early and late-stage drug development. By being a part of our diverse and inclusive team, you will have the opportunity to contribute to groundbreaking discoveries that have the potential to transform lives. If you are ready to make a significant impact in the field of clinical PBPK modeling, we invite you to apply now and embark on this exciting journey with us at AstraZeneca.,

We are looking for an experienced and dedicated Clinical Pharmacist to join our team The candidate should have a minimum of 1 year of experience Review and evaluate medication orders to ensure appropriateness, safety, and efficacy based on patient-specific factors such as age, condition, and comorbidities Collaborate with physicians, nurses, and other healthcare professionals to develop and implement patient-specific medication therapy plans Monitor patient progress and outcomes to adjust medications as needed Educate patients and caregivers on the proper use, side effects, and interactions of prescribed medications Ensure compliance with established protocols, regulatory requirements, and hospital policies Conduct medication reconciliation during patient transitions of care Participate in clinical rounds and provide drug information and therapeutic recommendations to healthcare teams Maintain accurate and updated patient medication records Assist in formulary management and participate in drug utilization reviews and audits Provide training and guidance to pharmacy staff, students, or residents Ask ChatGPT

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

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.,

As an ideal candidate for this position, you should hold a Master's degree in Pharmacy with a specialization in Pharmacology or Pharmaceutical Analysis coupled with 5-8 years of experience. Alternatively, a Ph.D. with 2-5 years of relevant experience in PK/PD Modelling and PBPK models would also be considered. Your responsibilities in this role would include developing and applying pharmacometric models to aid in drug development and regulatory submissions. You must possess a deep understanding of non-linear mixed effects modelling and be proficient in using software tools such as PBPK models, Phoenix, R, PoPK, QSP modelling, or similar platforms. Your expertise in pharmacokinetics/pharmacodynamics (PK/PD) modelling and First-in-human dose predictions will be crucial for the success of this role. Collaboration is key in this position, as you will work closely with clinical pharmacology, biostatistics, and other interdisciplinary teams to shape clinical trial designs and analyze data. Your tasks will also involve creating and executing model-based strategies to enhance dosing regimens and achieve optimal therapeutic outcomes. Ensuring the accuracy and quality of pharmacometric analyses and reports will be a significant part of your role. You will be expected to engage with regulatory agencies, preparing submission documents related to pharmacometric analyses. Staying updated on the latest advancements in pharmacometrics and integrating new methodologies and technologies as needed will be essential. Additionally, presenting your findings and strategies to project team meetings and cross-functional teams is crucial, highlighting your ability to collaborate effectively in a team environment.,

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.

Summary Join our dynamic and innovative global Computer-Aided Drug Discovery (CADD) group, now expanding to India! Be a part of our Hyderabad team, where we unite diverse talents to revolutionize the validation and development of new targets in Biomedical Research. As a driving force behind drug discovery, we are excited to find an exceptional computational scientist like you to join our global ranks. Imagine the opportunity to unlock hidden knowledge and disruptive insights from the vast and invaluable data collected by one of the world's most renowned pharmaceutical companies. We need your expertise, experience, and unwavering passion to help us extract this wealth of information. Collaborating with a multidisciplinary group of scientists, you will be at the forefront of crafting inventive solutions to the most pressing drug discovery challenges, forging new paths toward groundbreaking medicines. Are you ready to seize this extraordinary chance to make a significant impact in the field of drug discovery? We invite you to embark on this thrilling journey with us, as we push the boundaries of what's possible in scientific exploration. Join our team and be part of a revolution that will shape the future of medicine. Together, we will transform the landscape of drug discovery, accelerate breakthroughs, and change lives. Apply now and let your expertise shine in our dynamic and forward-thinking environment. About The Role Your Responsibilities Include : Drive the design of medicinal chemistry efforts by applying in-depth knowledge of structure-activity relationships (SAR), a profound understanding of target biology, and predictive methods for assessing on- and off-target activity, physical properties, pharmacokinetics/pharmacodynamics (PK/PD), and synthetic feasibility. Thrive at the intersection of experimental and groundbreaking digital technologies, with a particular emphasis on expertise in machine learning and artificial intelligence (AI) as applied to small molecule drug discovery. Stay abreast of scientific literature and engage with internal and external scientists to incorporate biological insights into lead characterization and screening initiatives. Collaborate with interdisciplinary project teams to facilitate effective decision-making throughout the target identification to candidate nomination process. This involves applying and developing predictive models based on high-content and time-resolved screening data, including imaging techniques. Drive hypothesis generation to enhance clinical success rates for programs involving small molecules, peptides, RNAs, protein degradation, molecular glues, transient covalent inhibitors, and kinetic stabilization of drug-target complexes. Take a leading role in cross-disciplinary mechanistic studies using physics-based modeling and simulation, biophysical characterization, and cellular validation. These studies will inform the strategic targeting strategies of discovery projects, aiming for optimal mechanisms of action (MoAs). Minimum Requirements Advanced degree in medicinal chemistry, computational chemistry, computational biology, computational chemical biology, or a related field. Candidates with a laboratory-based background in chemistry and biology, supplemented with strong computational experience, are also encouraged to apply. 5+ years of experience working with project teams in a drug discovery environment. Proven track record of innovation through analogue design, leading to significant impact on discovery projects. Familiarity with drug design tools and high-performance computing environments and strong publication history in peer-reviewed journals. Skills And Abilities Proactively anticipates project needs with a clinical focus. Demonstrates rigor and diligence in idea substantiation, analogue design, and experimentation. Strong team orientation with multitasking and adaptability in support and leadership roles. Effective listener with excellent written and oral communication skills. Proficient in data visualization to effectively communicate insights. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products cover various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, benefiting millions of patients worldwide. For more information about Azurity, please visit www.azurity.com. Azurity Pharmaceuticals is committed to fostering an inclusive workplace and is proud to be an Equal Opportunity Employer. The company attributes its success to its talented and dedicated team that prioritizes improving patients" lives by incorporating the best science and commitment to quality in all aspects of its work. Azurity seeks individuals who are highly motivated, possess integrity, dedication, and a creative spirit to excel within the organization. As a part of the Clinical Development team at Azurity, the Manager, Clinical Development plays a vital role in supporting early development activities across multiple therapeutic areas. Reporting to the Director, Clinical Development, the candidate will collaborate with stakeholders and team members to ensure scientific excellence, build effective relationships across Research & Development, and optimize the design and analysis of clinical investigations. **Principle Responsibilities:** - Design studies with a focus on technical, regulatory, and formulation aspects. - Collaborate with program managers and study teams to develop study plans aligned with the overall development plan and key milestones. - Ensure compliance with GCP, local and target regulatory guidelines, study protocols, and identify and address areas of concern. - Oversee study operations, including initiation, monitoring, and closeout, sample shipment, and communication with CROs, involving travel to CRO locations and study sites. - Independently perform non-compartmental PK analysis, PK modeling, and IVIVC communication of trial status and data to cross-functional teams. - Manage data repository, TMF, and critical study documents, proposing alternative strategies to optimize time, cost, and resources. - Contribute to the development, review, and approval of clinical study documents, such as ICF, IB, CRFs, study reports, and regulatory documents. **Qualifications And Education Requirements:** - Master's, Pharm.D, or PhD degree in clinical research, pharmacology, or equivalent field. - Minimum 6 years of pharmaceutical industry experience, with 4-5 years of experience in Phase 1 or 2 clinical development. - Sound understanding of US and ex-US regulatory clinical requirements, drug development continuum, and knowledge of regulatory approval processes. - Familiarity with ICH guidelines, GCP, biostatistics, and pharmacokinetics. - Strong organizational, interpersonal, and communication skills with the ability to work collaboratively in a cross-functional team. - Excellent analytical, problem-solving, and communication skills. By applying for this role, you confirm your ability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have concerns or disabilities that may affect your performance, please inform HR in advance.,

Core Responsibilities: 1. Design and Analyze PK Studies o Plan clinical PK studies synopsis and feasibility o Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software). o Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution. 2. Support Drug Development o Provide PK and statistical input in clinical development phase studies protocol o Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation o Support dose selection and optimization strategies for pivotal study design. 3. Regulatory Submissions o Deep understanding and knowledge of regulatory guidance (like US FDA, MHRA, EMA, HEALTH CANADA, ANVISA etc) documents pertain to BABE as well as clinical trials o Prepare and review PK-Statistical sections for regulatory documents (e.g., ANDA, IND, NDA, BLA, CTA). o Respond to Health Authority questions related to pharmacokinetics. 4. Cross-functional Collaboration o Work closely with clinical, bioanalytical, statistical and regulatory teams. o Participate in multidisciplinary project teams to inform decision-making. 5. Data Interpretation & Reporting o Summarize findings in study reports and scientific publications (as applicable). o Present PK data to internal teams and external teams (Sponsor, DSMB and other regulatory bodies) o Experience into study design, protocol writing, through knowledge of regulatory guidance for BA/BE studies as well as PK clinical trials.

Company Description Aizant® is an integrated drug development solutions provider, established by experienced pharmaceutical professionals with global exposure. As a rapidly growing contract research organization (CRO), Aizant partners with health care companies globally to support new molecular entities (NMEs), generics (ANDAs), and over-the-counter (OTC) products. We offer comprehensive solutions across drug development stages including preformulation, formulation development, analytical development, cGMP scale-up, stability, bioavailability, bioequivalence, bioanalysis, pharmacokinetics, and clinical diagnostics. Our mission is to add exponential value to our clients’ R&D programs from molecule discovery to commercialization and life cycle management. Role Description This is a full-time on-site role for a Quality Control Laboratory Manager located in Hyderabad. The Quality Control Laboratory Manager will be responsible for overseeing the daily operations of the quality control laboratory, ensuring compliance with cGMP standards, managing laboratory staff, and maintaining laboratory equipment. Additional responsibilities include developing and implementing quality control procedures, analyzing and interpreting data, and coordinating with other departments to ensure quality assurance throughout the production process. Qualifications Quality Control skills Laboratory Skills and familiarity with Laboratory Equipment Strong Analytical Skills Excellent leadership and team management abilities Strong organizational and communication skills 16 yrs of experience in the pharmaceutical industry

Preferred candidate profile M. Pharm (Pharmacology) / M.Sc. (Biochemistry / Pharmaceutical Chemistry) with 6-9 years or Ph.D. with 2-5 years' experience in PBPK & PK/PD modelling & Gastro plus; Simcyp software Role & responsibilities Experience in the development and application of pharmacometric models to support drug development and regulatory submissions Extensive experience with non-linear mixed effects modelling Proficient with software tools like PBPK models, Phoenix, R, PoPK, QSP modelling or similar platforms Strong background in pharmacokinetics/pharmacodynamics (PK/PD) modelling, First-in-human dose predictions. Collaborate with clinical pharmacology, biostatistics, and other interdisciplinary teams to inform clinical trial designs and data analysis Develop and implement model-based strategies to optimize dosing regimens and therapeutic outcomes Ensure the accuracy and quality of pharmacometric analyses and reports Engage with regulatory agencies and prepare regulatory submission documents related to pharmacometric analyses Stay abreast of the latest developments in pharmacometrics and incorporate new methodologies and technologies as appropriate Present findings and strategies to the project team meeting and cross-functional teams. Ability to work effectively in a team environment.

Preferred candidate profile M. Pharm (Pharmacology / Pharmaceutical Analysis) / M.Sc. (Biochemistry / Pharmaceutical Chemistry / Analytical Chemistry) with 3 - 6 years experience in Bioanalytical DMPK & Invivo PK. Role & responsibilities Planning and execution of invivo preclinical pharmacokinetic studies, invivo tissue distribution & mass balance studies in rodents. Expert in method development of NCEs using LC-MS/MS system Well verse with extraction techniques of molecules from various matrices like plasma/urine/tissues Experienced in surgical skills for rodents PK, excretion studies Conduct Bioanalysis of samples from in-vivo pharmacokinetic, tissue distribution studies, PK-PD & TK studies through LCMS/MS Prepare protocols and SOPs in line with industrys best practices Very strong in basics of all instruments, principles of chromatography, sample processing Knowledge of Phoenix WinNolin software will be added advantage

Role & responsibilities Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably design of experiments feasible under given lab conditions, support of sample-size calculations and application for animal testing licenses, randomization, data transfer into appropriate stats software, interpretation of results. Takes statistical responsibility for one or more standard experiments. Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects. Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects. Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI. Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results. Works independently at routine and complex statistical questions and tasks. Develops and implements standard processes for the analysis of routine experiments. Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers. What we're looking for Qualifications & Competencies: PhD or MSc in Biostatistics, Statistics or Mathematics, or related field. Strong communication skills. Ability to work independently as well as collaboratively, as required. Ability to translate statistical results into biological meaning Good knowledge of statistical programming languages (including SAS and R). Fluent English skills. At least two years as a non-clinical statistician focused on in vivo and in vitro experiments with significant time spent in pharma, biotech or similar sector.

" Jubilant Biosys is looking for Research Associate for DMPK department - Bengaluru location Experience : 3-5 Years Qualification : M. Pharmacy Roles & Responsibilities: Responsible for drug metabolism and pharmacokinetic support for discovery programs. Support preclinical bioanalysis Monitor Pharmacokinetics studies and support bioanalysis Providing pre-clinical ADME lead optimization support to small molecule Drug Discovery programs (Hit Identification to Clinical Candidate Selection) including Inflammation, Neuroscience, Metabolic Disorders and Anti-infective Research. Working as a DMPK subject matter lead in multidisciplinary/cross functional teams of drug discovery projects. Understand the Chemical Structure - ADME relationships and design apt strategies towards improving Drug like Properties of the New Chemical Entities. Understand the broader ADME requirements of various projects Conduct PK and PK/PD analysis through early pre-clinical development, and collaborate in PK/PD and efficacy study designs Collaborate with safety assessment group (in need basis) on study design Design tailor made ADME protocols for various projects Collate the obtained results and prepare presentations for internal and external meetings Contribute to the design of the critical path for various projects Prediction of human pharmacokinetic properties from in vitro and in vivo data Managing PK and PK/PD analysis through early pre-clinical development, and collaborates in PK/PD and efficacy study design developing robust PK/PD models Prediction of human pharmacokinetic properties from in vitro and in vivo data in preclinical species. Collaborates with safety assessment group on study design. Method validations and analytical trouble shooting; Data generation, compilation, report preparation; Lab note book, record keeping; SOP writing ",