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PI Health Sciences Ltd

<div>
 
 
 Job Title: Research Scientist &ndash; Process R&amp;D
 
 
 
 
 Department:
 
 R&amp;D &ndash; Process Development
 
 
 
 Industry:
 
 CDMO / API
 
 
 
 
 
 
 Purpose of the Role:
 
 
 
 To lead and execute the development, optimization, and scale-up of robust, cost-effective, and regulatory-compliant chemical processes for Active Pharmaceutical Ingredients (APIs) and intermediates, ensuring smooth technology transfer from lab to kilo lab and manufacturing.
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 1. Strategic Responsibilities
 
 
 <ul>
 <li>
 Drive innovation by designing synthetic routes that align with project timelines and regulatory requirements.
 </li>
 <li>
 Contribute to technology differentiation strategies that enhance the CDMO&rsquo;s scientific credibility and client value proposition.
 </li>
 <li>
 Collaborate with cross-functional teams (Analytical, QA/QC, Regulatory) to support integrated drug development solutions.
 </li>
 </ul>
 
 
 2. Operational Responsibilities
 
 
 <ul>
 <li>
 Perform route scouting, literature search, and develop robust and scalable chemical processes using QbD principles.
 </li>
 <li>
 Conduct laboratory experiments for reaction optimization, impurity profiling, and process safety assessment.
 </li>
 <li>
 Prepare and review technical reports, SOPs, and technology transfer documents.
 </li>
 <li>
 Ensure compliance with GMP/GLP and EHS standards during lab-scale and pilot-scale operations.
 </li>
 <li>
 Participate in troubleshooting during scale-up or commercial production batches and provide technical support during client audits.
 </li>
 </ul>
 
 
 3. Financial Responsibilities
 
 
 <ul>
 <li>
 Optimize process economics by reducing cycle time, yield improvement, and minimizing raw material costs.
 </li>
 <li>
 Support cost estimation activities during project proposals or client RFQs by providing technical insights.
 </li>
 </ul>
 
 
 4. People &amp; Collaboration Responsibilities
 
 
 <ul>
 <li>
 Guide junior team members on experimental planning, data interpretation, and documentation best practices.
 </li>
 <li>
 Promote a culture of safety, learning, and innovation within the team.
 </li>
 <li>
 Work closely with Program Management and Business Development to align project goals with customer expectations.
 </li>
 </ul>
 
 
 
 
 
 Qualifications &amp; Experience
 
 
 <ul>
 <li>
 M.Sc ( Organic Chemistry)
 </li>
 <li>
 3&ndash;9 years of experience in Process R&amp;D, preferably in CDMO organizations
 </li>
 <li>
 Hands-on expertise in synthesis, scale-up, impurity profiling, and technology transfer
 </li>
 <li>
 Familiarity with analytical techniques (HPLC, GC, NMR) and regulatory documentation
 </li>
 </ul>
 
 
</div>

Research Scientist

US Pharmacopeia

<div>
 
 Description
 
 
 
 At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds&mdash;regardless of background&mdash;to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
 
 
 
 Brief Job Overview
 
 
 
 This is a non-supervisory position to support development of Reference materials. The successful applicant in this role will work on projects including Analytical Method Development for in process samples for synthetic lab. The successful candidate will also perform a variety of non-routine and routine analytical tests, maintains safety &amp; GLP environment in the lab including evaluation of reference standards, development/validation (as per requirement) of official methods, stability studies and research projects in analytical department
 
 
 
 How will YOU create impact here at USP?
 
 
 
 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
 
 
 Additionally, USP&rsquo;s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
 
 
 
 The Scientist III Has The Following Responsibilities
 
 
 
 <ul>
 <li>
 [55%] Support to reaction monitoring, scale up and final analysis of samples as per monograph / in-house procedures including method development if required. Prepare development reports for Synthetic Support projects. Involve in project acceptance. Execute projects per the approved test protocols if assigned.
 </li>
 <li>
 [15%] Prepare, execute, and complete IQ/OQ/PQ of new instruments. Indent the required glass ware, chemicals, and columns for the ARD projects. Maintain GLP &amp; implement safety procedures while working in Lab. Perform other Projects whenever free from ARD activities. Perform other duties as assigned.
 </li>
 <li>
 [10%] Responsible for preparation of SOPs, protocols, reports, etc. Ensure the projects requirements by coordinating with the Purchasing department. Responsible for preparation of the records and documents. Ensure that the calibrations of the equipment&rsquo;s are performed as per the schedule
 </li>
 <li>
 [10%] Preparation and planning for ISO-9001 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner. Taking up any other additional responsibilities assigned by supervisor on a proactive basis and allotting additional responsibilities to the reporting staff in consultation with the supervisor. Participates in USP cross-functional teams as appropriate.
 </li>
 <li>
 [10%] Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
 <ul>
 <li>
 MSc. in Analytical Chemistry / Organic Chemistry/M. Pharm, having 6-8 years' experience in Analytical Research and Development or Ph.D. with 1-3 years of experience in Analytical Research and Development
 </li>
 <li>
 Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV-Visible, wet chemistry, etc.
 </li>
 <li>
 Experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures required.
 </li>
 <li>
 A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
 </li>
 <li>
 Ability to perform analytical method developments and method validations as and when required.
 </li>
 <li>
 Excellent technical writing and verbal communication skills are required.
 </li>
 <li>
 Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.
 
 
 </li>
 </ul>
 
 Additional Desired Preferences
 
 
 
 <ul>
 <li>
 Knowledge of handling LCMS, GCMS, IC and ICP-MS will be an added advantage.
 </li>
 <li>
 General chapter information, ELN, Empower and NuGenesis will be added advantage.
 </li>
 <li>
 Able to communicate effectively with both internal and external customers. Preferably familiar with electronic notebook documentation of experimental procedures.
 </li>
 <li>
 Skilled in evaluation and interpretation of data; Ability to multi-task.
 </li>
 <li>
 Skilled in anticipating, troubleshooting, and solving technical problems.
 </li>
 <li>
 Takes personal responsibility to ensure work is delivered on time and is of the highest quality.
 
 
 </li>
 </ul>
 
 Supervisory Responsibilities
 
 
 
 NA
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist III, ARD

<div>
 
 Description
 
 
 
 
 Who is USP?
 
 
 
 The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world&rsquo;s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.
 
 
 At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds&mdash;regardless of background&mdash;to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
 
 
 
 Brief Job Overview
 
 
 
 The role is engaged in the synthesis and delivery of USP Reference Standard candidate materials and API impurities through design and development of cost-effective synthetic routes. Candidate should carry literature search using scientific databases and work on planning and execution of synthesis of target molecules in mg to multigram/KG scale. Candidate should ensure the completion of assigned tasks as per timelines, prepare project reports, communicate with the team and update on the project progress. Candidate should be adherent to quality management systems (QMS) and lab safety practices
 
 
 
 How will YOU create impact here at USP?
 
 
 
 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
 
 
 Additionally, USP&rsquo;s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
 
 
 
 The Scientist III/IV Has The Following Responsibilities
 
 
 
 <ul>
 <li>
 Carry out literature search related to assigned projects using various scientific data base.
 </li>
 <li>
 Design synthetic routes for the target small molecules. Prepare project proposals with tentative cost estimates.
 </li>
 <li>
 Perform synthesis &amp; isolation of pharmaceutical analytical impurities, reference standards and degradation impurity standards.
 </li>
 <li>
 Procure key raw materials and reagents required for the project
 </li>
 <li>
 Perform the reactions in small as well as large scale in the lab for the synthesis of target compounds
 </li>
 <li>
 Purification of compounds through various techniques such as crystallization, column chromatography, and advanced flash purification systems.
 </li>
 <li>
 Troubleshooting synthesis and purification issues independently
 </li>
 <li>
 Contributing effectively towards more challenging and complex projects through innovative methodologies
 </li>
 <li>
 Ensuring the availability of chemicals and equipment required for the projects and forward the purchase requisitions
 </li>
 <li>
 Interpretation of analytical data of synthesized compounds by IR, NMR, Mass Spectra, Elemental analysis etc.
 </li>
 <li>
 Produce quality materials as per customer requirement
 </li>
 <li>
 Packaging of synthesized compounds
 </li>
 <li>
 Plan, execute and complete the projects as per the timelines
 </li>
 <li>
 Document all experiments conducted as per QMS guidelines.
 </li>
 <li>
 Responsible for preparation of SOPs, Protocols, reports etc. as per the need
 </li>
 <li>
 Responsible for review the records and documents
 </li>
 <li>
 Responsible to ensure the calibrations of the equipment as per the schedule
 </li>
 <li>
 Periodic check of the assigned equipment to ensure its working condition
 </li>
 <li>
 Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments as assigned
 </li>
 <li>
 Work on any other assigned tasks/ lab management activities.
 </li>
 <li>
 Conversant with lab safety norms and strictly follow them.
 </li>
 <li>
 Communicate within the team and cross functional teams
 </li>
 <li>
 Learn and practice Diversity, Equity, Inclusion &amp; Belonging culture.
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
 <ul>
 <li>
 Scientist III/IV &ndash; M Sc (Organic Chemistry) from a reputed university with minimum 6-10 years of industrial experience in Pharmaceutical Process R&amp;D or CRAMS or CRO set up (Or) Ph.D (Full Time) in Synthetic Organic Chemistry from a reputed group with minimum 1-7 years post-doctoral/industrial research experience in organic synthesis
 </li>
 <li>
 Strong background in synthetic organic chemistry, Interpretation of spectral data of compounds based on IR, NMR, HPLC, Mass, Elemental analysis and other analysis.
 </li>
 <li>
 Ability to independently search literature, design, optimize and develop synthetic processes for any given target molecules/APIs.
 </li>
 <li>
 Hands on experience in process development of diverse chemical class of APIs/ NCEs on lab scale.
 </li>
 <li>
 Excellent troubleshooting skills in synthesis and purification of target compounds.
 </li>
 <li>
 Should possess good verbal and written communication skills.
 </li>
 <li>
 Should possess good organizational, communication, and interpersonal skills.
 
 
 </li>
 </ul>
 
 Additional Desired Preferences
 
 
 
 <ul>
 <li>
 Extensive knowledge on wide range of organic reactions, and hands on experience in handling various sensitive chemicals/reagents.
 </li>
 <li>
 Track record of patents/ publications in synthetic organic chemistry/ process development.
 </li>
 <li>
 Should have exposure to GMP/GLP environment and documentation procedures. Have good practical, documentation &amp; presentation skills.
 </li>
 <li>
 Attention to detail, strategic thinking and problem-solving skills.
 </li>
 <li>
 Demonstrated ability to work both independently and as a member of a team with a passion for quality
 
 
 </li>
 </ul>
 
 Supervisory Responsibilities
 
 
 
 None, this is an individual contributor role.
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist III/IV, Synthetics Laboratory

<div>
 
 Description
 
 
 
 At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds&mdash;regardless of background&mdash;to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
 
 
 
 Brief Job Overview
 
 
 
 This is a hands-on non-supervisory position responsible for the oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS)/Analytical Reference Materials (ARMs) including but not limited to pharmaceutical analytical impurities, extractables &amp; leachables, polymers and certified reference materials (CRMs). This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for all candidate lots, technical assistance for collaborating labs, analytical data review and preparation of summary reports, preparation of packaging and Quality Control testing instructions
 
 
 
 How will YOU create impact here at USP?
 
 
 
 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
 
 
 Additionally, USP&rsquo;s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
 
 
 
 The SIII/SIV Position Has The Following Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for timely preparation of testing protocols for new/replacement reference materials, technical assistance for collaborating labs
 </li>
 <li>
 To review the analytical data received from the Collaborators and to prepare summary reports, preparation of packaging and QC testing instructions and assigning periodic re-test intervals. Independently maintains successful scheduling operations, necessary documents, complete and accurate information; and addresses quality issues to ensure availability of reference standards in a complex portfolio.
 </li>
 <li>
 Coordinate with labs, and reviews/interprets data from international collaborative studies.
 </li>
 <li>
 To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
 </li>
 <li>
 To provide guidance on the interpretation of test data, Proposes and designs studies to obtain necessary data to resolve complaints.
 </li>
 <li>
 To support Documentary Standard team by peer review of draft monograph
 </li>
 <li>
 To demonstrate technical understanding to internal and external audiences regarding USP's Reference Standards program.
 </li>
 <li>
 Engages in conversation about reference standards issues. Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
 </li>
 <li>
 Presents information to USP staff and external audiences.
 </li>
 <li>
 Facilitates additional cross-functional activities with other departmental staff and other USP staff.
 </li>
 <li>
 Performs other related duties as assigned.
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
 
 Scientist IV
 
 
 
 <ul>
 <li>
 MSc in chemistry or related field with 8-10 yrs of experience (or) Ph.D. in chemistry or related field with 3-5 yrs of experience
 
 
 </li>
 </ul>
 
 Scientist III
 
 
 
 <ul>
 <li>
 MSc in chemistry or related field with 6-8 yrs of experience (or) Ph.D. in chemistry or related field with 1-3 yrs of experience with the following skills
 </li>
 <li>
 Hands on experience in interpretation of results, characterization of the compound by spectral techniques (NMR, MASS, and IR).
 </li>
 <li>
 Knowledge on chromatographic techniques (HPLC, GC)
 </li>
 <li>
 Ability to handle multiple priorities in a fast-paced environment.
 </li>
 <li>
 Excellent written and verbal communications skills.
 
 
 </li>
 </ul>
 
 Additional Desired Preferences
 
 
 
 <ul>
 <li>
 Ability to read and interpret spectroscopic analyses data (NMR, IR, MS etc.)
 </li>
 <li>
 Hands on experience on chromatographic techniques such as (HPLC, GC).
 </li>
 <li>
 Prior experience with materials characterization using a variety of analytical techniques.
 </li>
 <li>
 Prior experience with lab investigations.
 </li>
 <li>
 Stability studies exposure.
 
 
 </li>
 </ul>
 
 Supervisory Responsibilities: NA
 
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist IV, Reference Standards Evaluation

Dr. Reddy's Laboratories

<div>
 
 Dr. Reddy&rsquo;s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because
 
 Good Health Can&rsquo;t Wait
 
 .
 
 
 
 
 We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
 
 
 
 
 For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity &ndash; to strengthen our core further (the next steps) and to build the future (the new bets).
 
 
 
 
 &lsquo;The Next and the New&rsquo; is how we aim to continue to be the partner of choice &ndash; purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose &ndash; helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
 
 
 
 
 Dr Reddy&rsquo;s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ &amp; nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
 
 
 
 
 
 
 Job Description
 
 
 
 
 
 Job Summary
 
 
 
 We are seeking a dynamic and experienced Analytical Scientist in Advanced Characterization Structural Elucidation Team (ACT-SEL) for utilizing sophisticated analytical techniques and instruments to investigate the composition, structure, and properties of substances at a molecular and atomic level. To Support Structural Elucidation across all modalities and mechanism elucidation into Research &amp; Development and to study release of drugs substance and structure of unknown Impurities through various method development and validation techniques.
 
 
 
 
 
 Roles &amp; Responsibilities
 
 
 
 
 <ul>
 <li>
 You will be responsible to employ advanced analytical techniques such as Gas Chromatography with Mass Detector( GCMS/MS), Inductively coupled Plasma Mass Spectrometry (ICPMS) , Inductively coupled Optical emission spectroscopy (ICP-OES), Atomic Absorption Spectroscopy (AAS), Ion Chromatography (IC) and other specialized techniques to analyse and characterize materials.
 </li>
 <li>
 You will be responsible to design and execution of experiments and the analysis of data. Also find the critical parameters and develop innovative solutions to complex problems in pharmaceutical research and development
 </li>
 <li>
 You will be responsible to deduce the chemical structure and composition of complex molecules, compounds, and materials, elucidating their atomic and molecular arrangements using advanced analytical methods.
 </li>
 <li>
 You will be responsible to develop and optimize analytical methods and protocols to facilitate the accurate and efficient characterization of diverse materials, ensuring the reliability and reproducibility of results.
 </li>
 <li>
 You will be responsible to perform comprehensive data analysis and interpretation of experimental results, employing statistical tools and software to extract meaningful insights into the structure, composition, and properties of the materials under investigation.
 </li>
 <li>
 You will be responsible to actively contribute to research projects aimed at developing novel methods for the characterization and elucidation of complex structures and stay updated with the latest advancements in analytical techniques and technologies
 </li>
 <li>
 You will be responsible to Collaborate with cross-functional teams, including chemists, material scientists, and engineers, to provide analytical support and contribute insights to research and development projects. Effectively communicate findings and recommendations to the team and stakeholders.
 </li>
 <li>
 You will be responsible to ensure adherence to quality control standards and regulatory requirements in all analytical processes, maintaining high standards of accuracy, precision, and reliability in data generation and analysis.
 </li>
 <li>
 You will be responsible to troubleshoot instrument-related issues and perform routine maintenance and calibration of analytical equipment to guarantee the accuracy and performance of instruments used in structural elucidation.
 </li>
 <li>
 You will be responsible to maintain comprehensive records of all experimental procedures, results, and observations. Prepare detailed reports and presentations summarizing analytical findings, methodologies, and conclusions for internal and external stakeholders.
 </li>
 <li>
 You will be responsible to adhere to strict safety protocols and guidelines while handling hazardous materials and operating complex analytical instruments. Ensure compliance with all relevant safety regulations and best laboratory practices.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 
 Educational qualification:
 
 MS in Pharmaceutical Analysis/Post Graduation in Pharma/Physics
 
 
 
 
 
 Minimum work experience:
 
 3-8 years of experience
 
 
 
 
 
 Skills &amp; attributes:
 
 
 
 
 Technical Skills
 
 
 
 
 <ul>
 <li>
 Hands on experience on Elemental analysis techniques such as Inductively coupled Plasma Mass Spectrometry (ICPMS) , Inductively coupled Optical emission spectroscopy (ICP-OES), Atomic Absorption Spectroscopy (AAS).
 </li>
 <li>
 Through understanding on ICHQ3D studies, Delamination studies, Extractable &amp; Leachable studies and its analytical methods.
 </li>
 <li>
 Understanding and experience on Gas chromatography with Mass Detector(GC-MS/MS) for method development and method validations for Nitrosamines analysis.
 </li>
 <li>
 Expertise in method development and validation of Ion Chromatography (IC) methods in critical projects.
 </li>
 <li>
 Experience in Instrument Calibration &amp; trouble shooting.
 </li>
 <li>
 Familiar with Current Good Laboratory Practices (CGLP).
 </li>
 </ul>
 
 
 
 
 Behavioural Skills
 
 
 
 
 <ul>
 <li>
 Excellent communication and interpersonal skills.
 </li>
 <li>
 Ability to work with cross functional teams.
 </li>
 <li>
 Strong analytical and problem-solving abilities.
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 About the Department
 
 
 
 
 
 
 Integrated Product Development Organisation
 
 
 
 
 
 We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) &amp; Other dosages
 
 
 Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&amp;D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.
 
 
 
 
 
 Benefits Offered
 
 
 
 At Dr. Reddy&rsquo;s we actively help to catalyse your career growth and professional development through personalised learning programs.
 
 
 The benefits you will enjoy at Dr. Reddy&rsquo;s are on par with the best industry standards. They include, among other things and other essential equipment, joining &amp; relocation support, family support (Maternity &amp; Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
 
 
 
 
 
 Our Work Culture
 
 
 
 Ask any employee at Dr. Reddy&rsquo;s why they come to work every day and they&rsquo;ll say, because Good Health Can&rsquo;t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we&rsquo;re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
 
 
 For more details, please visit our career website at
 
 https://careers.drreddys.com/#!/
 
 
</div>

Analytical Scientist

Novartis India

<div>
 
 Summary
 
 
 
 The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance.
 
 
 As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects.
 
 
 
 About The Role
 
 
 
 Key Responsibilities
 
 :
 
 
 
 <ul>
 <li>
 Strategy and delivery of PCS deliverables for products under development and in-market.
 </li>
 <li>
 Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products.
 </li>
 <li>
 Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts.
 </li>
 <li>
 Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives.
 </li>
 <li>
 Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines.
 </li>
 <li>
 Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books.
 </li>
 <li>
 Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables.
 </li>
 <li>
 Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement.
 </li>
 <li>
 Act as a nonclinical scientific liaison to Submissions &amp; Documentation (S&amp;D) vendor supporting nonclinical submission document management.
 </li>
 <li>
 Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
 </li>
 <li>
 Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines.
 
 
 </li>
 </ul>
 
 Essential Requirements
 
 
 
 <ul>
 <li>
 PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing
 </li>
 <li>
 In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment
 </li>
 <li>
 Understanding of GLP principles in nonclinical studies and submission writing.
 </li>
 <li>
 Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
 </li>
 <li>
 Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred.
 </li>
 <li>
 Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred.
 </li>
 <li>
 Registration and certification with one of the International Toxicology registers.
 
 
 </li>
 </ul>
 
 Desirable Requirement
 
 
 
 <ul>
 <li>
 Animal Models ,Communication Skills, Data Analysis.
 </li>
 <li>
 Ethics ,Laboratory, Problem Solving.
 </li>
 <li>
 Regulatory Compliance.
 </li>
 <li>
 Research.
 </li>
 <li>
 Risk Assessment.
 </li>
 <li>
 Toxicology.
 
 
 </li>
 </ul>
 Commitment to Diversity &amp; Inclusion: :
 
 
 
 We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
 
 
 
 Why Novartis: Our purpose is to reimagine medicine to improve and extend people&rsquo;s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our
 
 
 people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
 
 
 You&rsquo;ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
 
 
 
 Commitment To Diversity And Inclusion
 
 
 
 Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
 
 
 Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
 
 
 
 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&rsquo; 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&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
</div>

Principal Scientist 2 - Preclinical Safety

ProPharma

<div>
 For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.
 
 
 
 Job Summary
 
 
 
 The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
 </li>
 <li>
 Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
 </li>
 <li>
 Authoring of Signal Management Reports.
 </li>
 <li>
 Performing literature search and validity check for the aggregate reports.
 </li>
 <li>
 Reconciliation of relevant process trackers.
 </li>
 <li>
 Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
 </li>
 <li>
 Generation of Line Listings (LL) from safety database
 </li>
 <li>
 </li>
 <li>
 Providing reliable support for high priority Ad-hoc activities.
 
 
 </li>
 </ul>
 
 Necessary Skills And Abilities.
 
 
 
 <ul>
 <li>
 Analytical and problem-solving skills.
 </li>
 <li>
 Sound organizational skills
 </li>
 <li>
 Able to work within a team in an open and professional manner
 </li>
 <li>
 Excellent attention to detail and focus on quality
 </li>
 <li>
 Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV
 </li>
 <li>
 Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines.
 </li>
 <li>
 Awareness of global culture and willingness to work in a matrix environment
 </li>
 <li>
 Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs."
 </li>
 <li>
 Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
 </li>
 <li>
 Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
 </li>
 <li>
 Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
 
 
 </li>
 </ul>
 
 Educational Requirements
 
 
 
 <ul>
 <li>
 Bachelor/master&rsquo;s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
 
 
 </li>
 </ul>
 
 Experience Requirements
 
 
 
 <ul>
 <li>
 2+ years&rsquo; experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection
 </li>
 <li>
 Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients
 </li>
 <li>
 Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports
 
 
 </li>
 </ul>
 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
 
 
 ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
</div>

Pharmacovigilance Safety Scientist

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