6,203 Pharmaceutical Project jobs in India
Clinical Pharmacologist - Drug Development
Posted 19 days ago
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Job Description
Responsibilities:
- Design and develop clinical pharmacology study protocols, including Phase I-IV studies, to characterize the PK/PD profiles of novel drug candidates and marketed products.
- Oversee the execution of clinical pharmacology studies, ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and scientific rigor.
- Analyze and interpret complex clinical pharmacology data, including PK, PD, and population PK/PD modeling.
- Prepare high-quality clinical pharmacology reports, summaries, and sections for Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other regulatory submissions.
- Provide expert scientific and strategic input on drug development programs, influencing dose selection, dosing regimens, and clinical trial designs.
- Collaborate effectively with internal teams (e.g., clinical operations, biostatistics, regulatory affairs, project management) and external partners (e.g., clinical research organizations (CROs), investigators).
- Stay current with scientific literature, regulatory guidelines, and industry best practices in clinical pharmacology.
- Contribute to the development of scientific publications and presentations.
- Evaluate and integrate data from various sources (e.g., preclinical, clinical, real-world evidence) to inform drug development decisions.
- Mentor junior pharmacologists and contribute to the scientific growth of the team.
- Ph.D. in Pharmacology, Pharmaceutical Sciences, Pharmaceutics, or a related discipline; MD with relevant experience will also be considered.
- Minimum of 5-7 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry.
- Proven expertise in designing, conducting, and analyzing clinical pharmacology studies (PK/PD, TGI, BA/BE).
- Strong understanding of regulatory requirements (FDA, EMA) related to clinical pharmacology.
- Experience with population PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin) is highly desirable.
- Excellent scientific writing and oral communication skills.
- Demonstrated ability to work independently and collaboratively in a remote environment.
- Strong analytical and problem-solving abilities.
- Experience with therapeutic areas relevant to the company's pipeline is a plus.
Senior Formulation Scientist, Drug Development
Posted 6 days ago
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Job Description
Responsibilities:
- Lead the formulation development of new chemical entities (NCEs) and existing drugs into various dosage forms (e.g., oral solids, liquids, injectables).
- Design and conduct pre-formulation studies to understand the physicochemical properties of drug substances.
- Develop robust, scalable, and manufacturable formulations that meet product specifications and regulatory requirements.
- Characterize drug products using a variety of analytical techniques (e.g., HPLC, dissolution testing, DSC, XRD).
- Troubleshoot formulation and process-related issues encountered during development.
- Prepare development reports, protocols, and regulatory submission documents (e.g., IND, NDA).
- Collaborate with analytical development, process development, and manufacturing teams to ensure seamless technology transfer.
- Stay abreast of emerging trends, technologies, and regulatory guidelines in pharmaceutical formulation.
- Supervise and mentor junior scientists and technicians in the formulation laboratory.
- Contribute to the strategic planning of the formulation development pipeline.
- Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related discipline.
- Minimum of 6-9 years of hands-on experience in pharmaceutical formulation development within the industry.
- Proven track record of successfully developing and progressing formulations through the drug development pipeline.
- In-depth knowledge of various dosage forms, excipients, and drug delivery systems.
- Proficiency in analytical techniques used for drug product characterization.
- Strong understanding of regulatory requirements (e.g., FDA, EMA) for drug product development and submission.
- Excellent problem-solving, critical thinking, and experimental design skills.
- Strong written and verbal communication skills, with the ability to present scientific data effectively.
- Experience in managing projects and leading small teams is highly desirable.
This position is based in our state-of-the-art facility in Noida, Uttar Pradesh, IN . This role requires on-site presence and is not eligible for remote work.
Senior Formulation Scientist, Drug Development
Posted 10 days ago
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Job Description
Responsibilities:
- Design, develop, and optimize pharmaceutical formulations for various dosage forms (e.g., oral solids, injectables, topical).
- Conduct pre-formulation studies, including solubility, stability, and compatibility assessments of active pharmaceutical ingredients (APIs).
- Select appropriate excipients and formulation strategies to achieve desired drug delivery profiles and product performance.
- Develop and validate analytical methods for characterization of formulations.
- Scale-up formulation processes from laboratory to pilot and commercial manufacturing scales.
- Troubleshoot formulation and manufacturing-related issues.
- Conduct stability studies according to ICH guidelines and interpret results.
- Prepare comprehensive formulation development reports and contribute to regulatory submissions (e.g., IND, NDA).
- Collaborate with analytical development, process development, and manufacturing teams.
- Stay abreast of the latest advancements in pharmaceutical formulation science and drug delivery technologies.
- Mentor junior scientists and provide technical guidance.
- Ensure all activities are conducted in compliance with cGMP and other relevant regulatory standards.
- Evaluate new technologies and equipment for formulation development.
- Contribute to the intellectual property strategy of the company.
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
- Minimum of 8 years of hands-on experience in pharmaceutical formulation development.
- Extensive knowledge of various dosage forms, drug delivery systems, and excipients.
- Experience with pre-formulation studies, analytical method development, and stability testing.
- Proven ability to scale-up formulation processes.
- Strong understanding of cGMP principles and regulatory requirements (e.g., FDA, EMA).
- Excellent scientific reasoning, problem-solving, and data interpretation skills.
- Strong written and oral communication skills, with experience authoring technical reports and regulatory documents.
- Ability to work independently and effectively manage projects in a remote environment.
- Familiarity with common laboratory equipment and software used in formulation development.
- This role supports our operations in **Visakhapatnam, Andhra Pradesh, IN**, but is entirely remote.
Senior Formulation Scientist - Drug Development
Posted 11 days ago
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Job Description
Principal Scientist - Oncology Drug Development
Posted 13 days ago
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Job Description
Key Responsibilities:
- Lead the strategic direction and execution of preclinical and early-phase oncology drug development projects.
- Design and manage in vivo and in vitro studies to evaluate the efficacy, safety, and pharmacokinetics of novel oncology therapeutics.
- Collaborate closely with medicinal chemists, translational scientists, and clinical development teams to advance drug candidates.
- Interpret complex experimental data and translate findings into actionable development plans.
- Develop and implement biomarker strategies to support patient selection and therapeutic response monitoring.
- Stay at the forefront of oncology research, identifying emerging trends, technologies, and therapeutic opportunities.
- Prepare comprehensive regulatory submission documents (e.g., IND applications).
- Mentor and guide junior scientists and research staff, fostering scientific growth and excellence.
- Manage relationships with external collaborators, including academic partners and contract research organizations (CROs).
- Effectively communicate research progress, strategic decisions, and project outcomes to senior leadership and stakeholders.
- Ph.D. in Oncology, Molecular Biology, Immunology, Pharmacology, or a related field.
- Minimum of 10 years of progressive experience in oncology drug discovery and development within the pharmaceutical or biotechnology industry.
- Proven track record of successfully advancing oncology drug candidates from preclinical to clinical stages.
- Deep understanding of cancer biology, tumor microenvironment, and various therapeutic modalities (e.g., small molecules, antibodies, cell therapies).
- Extensive experience with preclinical pharmacology models and translational research strategies.
- Excellent leadership, project management, and team collaboration skills.
- Strong analytical and problem-solving abilities, with a data-driven approach to decision-making.
- Exceptional written and verbal communication skills, including experience with regulatory document preparation.
- Ability to thrive and lead effectively in a fully remote work environment.
- Demonstrated ability to publish in high-impact journals and present at international conferences.
Senior Formulation Scientist - Drug Development
Posted 16 days ago
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Job Description
Key Responsibilities:
- Designing and executing pre-formulation studies to characterize drug substances and identify appropriate excipients.
- Developing and optimizing various dosage forms, including oral solids, liquids, semi-solids, and potentially sterile injectables, for small molecules and biologics.
- Performing stability studies according to ICH guidelines and analyzing results to determine shelf-life and storage conditions.
- Investigating and troubleshooting formulation-related issues encountered during development and manufacturing.
- Collaborating with analytical development teams to establish appropriate analytical methods for formulation characterization and quality control.
- Leading the scale-up of promising formulations from laboratory bench to pilot plant and manufacturing scale.
- Preparing comprehensive formulation development reports, CMC documentation, and regulatory submission support.
- Staying abreast of the latest advancements in formulation technologies, drug delivery systems, and regulatory requirements.
- Mentoring junior scientists and contributing to a collaborative team environment.
- Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards.
Senior Formulation Scientist, Drug Development
Posted 20 days ago
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Job Description
Key Responsibilities:
- Design, develop, and optimize pharmaceutical formulations for various dosage forms.
- Conduct pre-formulation studies, including solubility, stability, and compatibility assessments.
- Select appropriate excipients and carriers to achieve desired drug delivery profiles.
- Perform dissolution testing, drug release studies, and pharmacokinetic assessments.
- Develop and validate analytical methods for formulation characterization.
- Support formulation scale-up and technology transfer to manufacturing.
- Troubleshoot formulation challenges and identify root causes of issues.
- Collaborate with analytical development, process development, and regulatory teams.
- Prepare detailed reports, protocols, and submission documents.
- Stay abreast of industry trends, new technologies, and regulatory guidelines in formulation development.
- Contribute to intellectual property generation through patent applications.
- Master's degree or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 7 years of relevant experience in pharmaceutical formulation development.
- Proven expertise in developing various dosage forms (e.g., tablets, capsules, injectables, topical formulations).
- Strong understanding of physical chemistry, materials science, and drug delivery principles.
- Hands-on experience with laboratory equipment for formulation development and characterization.
- Knowledge of GMP requirements and regulatory guidelines for drug product development.
- Excellent analytical, problem-solving, and experimental design skills.
- Proficient in data analysis and scientific report writing.
- Strong collaboration and communication skills.
- Experience with controlled-release formulations or specialized delivery systems is a plus.
- Familiarity with CMC (Chemistry, Manufacturing, and Controls) documentation.
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Senior Research Scientist, Oncology Drug Development
Posted 11 days ago
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Job Description
Responsibilities:
- Design, plan, and execute complex in vitro and in vivo experiments to evaluate the efficacy and safety of novel oncology drug candidates.
- Develop and validate assays for target engagement, pharmacodynamics, and biomarker analysis.
- Interpret experimental results, troubleshoot technical challenges, and propose innovative solutions.
- Analyze and present data clearly and concisely to internal teams and external collaborators.
- Contribute to the preparation of research reports, publications, and regulatory filings.
- Stay abreast of the latest scientific literature and technological advancements in oncology and drug discovery.
- Mentor and guide junior research associates, fostering a collaborative and high-performing team environment.
- Collaborate effectively with medicinal chemistry, pharmacology, toxicology, and clinical development teams.
- Ensure all research activities are conducted in compliance with company policies and regulatory guidelines.
- Ph.D. in Molecular Biology, Cancer Biology, Pharmacology, or a related field with a strong emphasis on oncology.
- Minimum of 5 years of postdoctoral or industry experience in drug discovery and development, with a proven track record in oncology.
- Extensive hands-on experience with various cancer models (cell lines, patient-derived xenografts) and relevant biological assays.
- Proficiency in data analysis software and statistical methods.
- Excellent written and verbal communication skills, with the ability to present complex scientific information effectively.
- Demonstrated ability to work independently and as part of a remote team.
- Strong problem-solving skills and a creative approach to scientific challenges.
- Experience with regulatory submission processes is a plus.
Senior Clinical Research Associate - Drug Development
Posted 19 days ago
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Job Description
Responsibilities:
- Plan and execute clinical trial monitoring activities.
- Conduct site initiation, routine monitoring, and close-out visits.
- Ensure compliance with study protocols, SOPs, and regulatory guidelines (GCP, ICH).
- Verify data accuracy and integrity through source document review.
- Manage relationships with investigators, study coordinators, and site staff.
- Identify, document, and resolve site-level issues and deviations.
- Train and mentor site personnel and junior CRAs.
- Prepare monitoring reports and track action items.
- Ensure timely submission of regulatory documents.
- Contribute to the development of study-related documents (e.g., protocols, ICFs).
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum 5-7 years of experience as a Clinical Research Associate.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience in site management, monitoring, and auditing.
- Strong understanding of clinical trial processes from start to finish.
- Excellent written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites as required.
- Detail-oriented with strong organizational and time management skills.
Senior Research Scientist - Oncology Drug Development
Posted 20 days ago
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Job Description
Responsibilities:
- Lead and manage research projects focused on identifying and validating novel oncology drug targets.
- Design, execute, and interpret complex in vitro and in vivo experiments to evaluate the efficacy and mechanism of action of potential therapeutic candidates.
- Develop and optimize assays for drug screening and characterization.
- Collaborate closely with medicinal chemists, pharmacologists, and clinical development teams to advance drug candidates from discovery through preclinical development.
- Analyze and interpret complex biological data, ensuring scientific rigor and reproducibility.
- Stay abreast of the latest scientific literature and advancements in oncology research and drug development.
- Contribute to the preparation of regulatory submissions (e.g., IND applications).
- Present research findings at internal meetings and external scientific conferences.
- Mentor and guide junior scientists and research associates.
- Ensure compliance with all laboratory safety regulations and company policies.
- Contribute to the development of intellectual property through patent filings.
- Manage external collaborations with academic institutions and contract research organizations.
Qualifications:
- Ph.D. in Cancer Biology, Molecular Biology, Pharmacology, or a related field.
- Minimum of 7 years of post-doctoral research experience in oncology drug discovery and development within the pharmaceutical or biotechnology industry.
- Proven track record of leading successful research projects and contributing to IND filings.
- Extensive hands-on experience with a variety of preclinical oncology models and assays (e.g., cell-based assays, in vivo xenografts, PDX models).
- Deep understanding of cancer biology, tumor microenvironment, and cancer immunology.
- Proficiency in molecular and cell biology techniques.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with experience in scientific writing and presentation.
- Demonstrated ability to work effectively in a collaborative team environment.
- Experience with data analysis software and statistical methods.
- A passion for scientific innovation and a commitment to improving cancer patient outcomes.
This is an exciting opportunity for a seasoned oncology researcher to make a significant impact on the development of life-saving therapies. If you are driven by scientific discovery and possess the required expertise, we encourage you to apply.