37 Pharmacokinetics Jobs - Page 2

Bioanalyst who will be responsible for high-quality discovery bioanalysis to support preclinical in vitro ADME and in vivo PK studies. LC-MS/MS based bioanalytical techniques to analyse biological samples in support of Drug Discovery projects. Required Candidate profile Around 5-8 years of experience in discovery bioanalysis to support in vitro ADME and pharmacokinetic studies.

Roles & Responsibility: Perform method development, method validation and study sample analysis under supervision of Project Manager (s). Passaging of cells as well as performing cell based assays while maintaining aseptic conditions in cell culture laboratory. Perform ELISA & other Ligand Binding Assay according to study protocol guidelines and/or SOPs Processing of specimens to support the clinical studies. Preparation of required reagents and solvents. Preparation of SOP(s) and work instruction. Following GLP, GDP, GCLP & other good practices. Desirable candidate: MSc BioTech/ Biochemistry/ Microbiology or BTech Biotech fresher. 0-1 year of relevant experience will be preferable. Sound knowledge on Immunology. Good communication skills, analytical skills and team coordination.

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

Designation: Research Scientist - Document Reviewer Job Location: Bangalore Department: Clinical Development About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve Rproductivity, speed up time to market and lower the cost of innovation. Job Purpose: The position holder is responsible for document review related to Bioanalysis, including Pharmacokinetics and Immunogenicity. Key Responsibilities: Review technical documentation and record review in a report Provide assistance/participate for the preparation of SOPs etc. Execution of review documents in accordance with planned timelines Technical data reviews for studies utilizing analytical skills, technical knowledge and utilizing excellent regulatory guidelines requirements Capable to focus attention to detail review and identify critical observations Routine review of laboratory log books, equipment calibration and validation status etc. Handle multiple studies data review simultaneously in an efficient and effective manner. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field. Technical/functional Skills: Good knowledge of MS Office applications is necessary Handling audits and participation in audits is preferable Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. Experience: 12-15 years of total experience in Document review. Behavioral Skills: Should be independent. Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure 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.

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

ql-editor "> Job Summary We are seeking a skilled In Vitro Statistician with 2-7 years of experience to support our research and development teams in statistical analysis of in vitro studies. The ideal candidate will be responsible for designing experiments, analyzing data, and providing statistical insights to support decision-making in pharmaceutical, biotechnology, or life sciences research. Key Responsibilities: Design, develop, and analyze in vitro study experiments, ensuring statistical rigor and accuracy. Apply appropriate statistical models and methodologies for data interpretation. Work closely with scientists, biologists, and researchers to provide statistical guidance in study design and result evaluation. Utilize statistical software (e.g., SAS, R, JMP, or Python) to conduct data analysis, visualization, and reporting. Validate and verify data integrity, ensuring compliance with regulatory guidelines (FDA, ICH, GLP). Develop and review statistical analysis plans (SAPs), study protocols, and technical reports. Support regulatory submissions by preparing statistical documentation and reports. Stay updated with the latest statistical methods and best practices in in vitro research. Required Qualifications Skills: Master s or Ph.D. in Statistics, Biostatistics, Bioinformatics, or a related field. 2-7 years of experience in statistical analysis of in vitro studies, preferably in the pharmaceutical, biotechnology, or life sciences sector. Strong knowledge of experimental design, regression models, ANOVA, DOE, and multivariate analysis. Proficiency in statistical software (SAS, R, JMP, Python, or equivalent). Experience with data visualization, trend analysis, and predictive modeling. Understanding of regulatory requirements and compliance standards (FDA, ICH, GLP). Excellent communication skills to present findings to cross-functional teams. Strong problem-solving skills and attention to detail. Preferred Qualifications: Experience in bioassays, pharmacokinetics, biomarker analysis, or toxicology studies. Familiarity with machine learning and AI-based statistical modeling. Knowledge of clinical and preclinical statistical applications.

About 2070 Health - W Health has set up India s first healthcare focused Venture Studio called 2070 Health - an innovation platform that builds transformative healthcare companies from scratch by discovering disruptive opportunities in whitespaces. Distinct from the accelerator approach, our venture studio is closely involved in idea generation, day-to-day operations, and strategic decisions of growing the new business. Companies incubated in the last 15 months include Elevate Now , Nivaan Care , Reveal Healthtech and BabyMD . About the Stealth Company - We at 2070Health are building Indias leading infusion business, focused on delivering best-in-class outcomes, exceptional patient experiences, expanded access, and curated ancillary services through day care centres. We are hiring for a Pharmacist with a strong background in chemotherapy drug procurement, checking, and mixing. The ideal candidate will play a vital role in ensuring safe and effective medication use for oncology patients, contributing to personalized treatment plans, and enhancing overall patient care in a collaborative clinical setting Responsibilities - 1. Chemotherapy, Targeted Therapy, and Immunotherapy Preparation and Compounding: Responsible for accurately mixing and compounding chemotherapy, targeted therapy, and immunotherapy drugs, ensuring precise dosing and adherence to safety protocols. Follow strict sterility and handling guidelines for hazardous drugs, ensuring optimal patient safety and regulatory compliance. 2. Pharmacokinetics Analysis Drug-Interaction Assessment: Review patient medical histories to adjust drug dosages, ensuring efficacy while minimizing side effects. Assess potential drug interactions, especially with complex cancer regimens, to ensure safe and effective treatment. 3. Patient Counselling and Education: Provide comprehensive counselling on chemotherapy and other oncology drugs, educating patients on proper use, managing side effects, and fostering adherence to treatment regimens. Offer emotional support to patients and families coping with cancer treatment challenges. 4. Medication Safety and Clinical Protocols: Ensure the accuracy of chemotherapy administration by closely monitoring treatment and minimizing errors. Collaborate in the development and implementation of clinical protocols, ensuring they align with best practices and regulatory standards for optimal oncology care. Report medication errors and adverse drug reactions, conducting Root Cause Analysis (RCA) and implementing Corrective and Preventive Actions (CAPA) to prevent recurrence. 5. Pain Management and Palliative Care: Collaborate with oncologists to manage pain and other symptoms in cancer patients, optimizing therapy to improve quality of life. Support palliative care initiatives, addressing patient comfort through appropriate pharmacological interventions. 6. Immunotherapy and Targeted Therapy Management EHR: Stay up-to-date with advancements in targeted therapies and immunotherapies, integrating these treatments into patient care plans. Utilize Electronic Health Records (EHR) to track treatments and ensure accurate documentation, coordinating care effectively with the healthcare team. 7. Clinical Trial Support: Provide key support for oncology clinical trials, ensuring the correct preparation and administration of investigational drugs. Adhere to trial protocols, monitor patient responses, and maintain accurate records for regulatory compliance. 8. Research and Evidence-Based Practices: Engage in research activities to evaluate new therapies and treatment regimens. Integrate the latest evidence into clinical practice, ensuring that patient care is continually improved and aligned with current research. 9. Collaboration and Team Training: Work closely with oncologists, nurses, and other healthcare professionals to ensure patients receive appropriate and safe treatments. Collaborate on treatment plans, patient monitoring, and adjustments to therapy as needed, ensuring a comprehensive and coordinated approach to patient care. Provide monthly training to nursing staff and Resident Medical Officers (RMOs) on drug safety, medication management, and adherence to NABH guidelines to ensure consistent and high-quality care across the team. 10. Escalation Management: Actively manage and resolve any medication-related issues or adverse events that arise, ensuring that appropriate steps are taken to resolve the issue promptly. Collaborate with the clinical team to escalate issues appropriately, ensuring the safety and well-being of patients. 1. Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) or Doctor of Pharmacy (Pharm.D) from a recognized institution. 2. Active pharmacy license. 3. Minimum of 5 years of experience as a pharmacist. 4. Hands-on experienc

Job Title: Associate Director, PKPD / Pharmacometric Data/SAS Programmer Career Level - E Introduction to Role: Are you ready to make a significant impact in the world of drug development? We are seeking an Associate Director for, PKPD / Pharmacometric Data/SAS Programmer belonging to the Clinical Pharmacology and Quantitative Pharmacology programming team. This role focuses on all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study and project levels. You will be instrumental in influencing critical decision making throughout all phases of drug development and regulatory interactions. Accountabilities: As an Associate Director, you will be accountable for expert data integration, manipulation, and preparation results at the study and project level. You will execute state-of-the-art data preparation techniques with direct value for the study and/or project. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations. Essential Skills/Experience: 10+ years of hands-on experience in SAS programming. Strong understanding of pharmacokinetics, pharmacodynamics, and their application in drug development. Strong SAS/R programming skills Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM) Demonstrated data programming and clinical development expertise Good knowledge of global regulatory, compliance, processes, standards Capability to develop tools to support data integration & visualization Bachelors degree MS preferred with relevant experience required Demonstrated experience in regulatory submissions and interdisciplinary team leadership Varied programming languages (SAS, R, Python) Experience in early and late-stage drug development Excellent problem-solving, communication, and project management skills. Proficient oral and written English communication skills Knowledge in pharmacology, drug targets and core Therapy areas (e.g. Oncology, Respiratory, Renal Metabolism etc.) Quantitative/Scientific background (Statistics, Engineering, Biological Science) Desirable: Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM, Monolix, R, Matlab) Scientific publishing in the field on pharmacometrics 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. Why AstraZeneca? Join our Biopharmaceuticals R&D team and be part of a team where you are empowered to follow the science. At AstraZeneca, we are unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Ready to make a difference? Apply today and join us in pushing the boundaries of science to deliver life-changing medicines!

Design & execute in vivo experiments using rodent models to evaluate pharmacological properties of drug candidates, focusing on dosing, administration routes, & model selection. Conduct safety & efficacy studies (oncology, metabolic disorder, skin disorders) in disease-relevant rodent models, monitor disease progression, & assess treatment endpoints following established protocols. Conduct Pharmacokinetics (PK) study in mice and rats using different modes of administrations Conduct single and multiple day dose tolerability study Analyze in vivo data, generate reports, & contribute to regulatory submissions & publications. Collaborate with cross-functional teams (in-vitro pharmacologists, medicinal chemists, bio-analytical teams) to integrate pharmacology data into drug development strategies. Ensure adherence to ethical standards & regulatory guidelines, maintaining high animal care & welfare. Oversee vivarium management, including creating SOPs & liaising with regulatory bodies (CPCSEA) Prepare reports, presentation materials, & contribute to scientific publications & regulatory submissions. Ensure compliance with local regulations, bio-safety, & data integrity standards in animal research. Job Types: Full-time, Permanent, Fresher Pay: ₹500,000.00 - ₹700,000.00 per year Benefits: Paid sick time Provident Fund Schedule: Day shift Work Location: In person

a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.

Company Description Welcome to ZES Bioscience Pvt. Ltd., a global hub for toxicology testing and safety assessment services located in Bhopal. Our CCSEA-certified research facility ensures compliance with international standards, specializing in preclinical toxicology, pharmacokinetics, and safety assessment for pharmaceutical and chemical industries. We have a skilled workforce dedicated to helping clients make informed pipeline decisions, shaping the future of healthcare with precision and quality. Role Description This is a full-time on-site role for a Graphic Designer at ZES Bioscience Pvt. Ltd. The Graphic Designer will be responsible for creating visual concepts, developing branding materials, designing logos, working on typography, and creating graphics to support the company's communication and marketing efforts. Qualifications Graphics and Graphic Design skillsLogo Design and Branding experienceTypography skillsCreative thinking and problem-solving abilitiesProficiency in Adobe Creative Suite (Photoshop, Illustrator, InDesign)Strong attention to detail and time-management skills.

Role & responsibilities Hands on experience on Immunoassay method development, validation and bioanalysis using ELISA, MSD and cell based assay platforms for Immunogenicity & PK assessment. Familiar with large molecule bioanalytical regulatory requirements for ADA & PK assessment. Good documentation & review skills Team player and able to guide junior level staff GLP/GCLP experience is additional plus.