11 Solubility Jobs

Position Description Business Division: CreAgro Department: Chemistry Location: Udaipur Position Title: Research Scientist – Analytical Level: Executives Reporting to (Title): Group Leader - Analytical Position Purpose The incumbent would provide support to the Process Research team by providing assistance in reaction monitoring on (HPLC, GC, NMR, IR, LCMS), characterization and data generation of submitted compounds, final product assay method development. Analysis of impurities, physical characterizations, residue content, stability studies, etc. Strategic Responsibilities Actively imbibing the values and philosophy of PI Industries Efficient contribution to the overall success of CreAgro Analytical Chemistry through scientific contribution and supporting team performance according to objectives and targets being set by the leadership team Remain at the cutting edge of knowledge required for the new a.i. discovery activity in crop protection through constant updating of personal knowledge and own skill-sets Operational Responsibilities Experimental determination of several phys-chem parameters like Small molecule’s Aqueous solubility, Solubility in different solvents, pKa, logP, Henry’s Law constant as per OECD guidelines Strong theoretical back ground on the aforesaid phys-chem parameters Analysis of the phys-chem experimental results using Microsoft Excel and GraphPad Prism Good knowledge of statistical analysis like paired student t-test and others Conducting Photo Stability and hydrolytic stability studies Operational skill in Spectroscopic & Chromatographic Techniques Evaluate different equipments required for the work and operation of the same Prepare the Study Strategy and implement as per SOP Documentation and reporting of analytical results Comply to all safety requirements of the role Financial Responsibilities Work with in the limit of budgets Suggest cost improvement areas to the Team Leader / Group Leader People Responsibilities Collaborate with team members and cross functional teams to ensure meeting research objectives Ensure team harmony through collaboration and active participation in all team discussion Education Qualification MSc/Organic Chemistry/Analytical Chemistry/Agriculture from a reputed University / Institute with excellent academic credentials Work Experience 2-5 years of hands on experience on Assay of a.i. by potentiometry, HPLC, GC, impurity purification/analysis Experience in chromatography method validation is an added advantage Industry to be Hired from Agro Chemical / Pharma Generics / Research Universities or Institutes Functional Competencies Scientific Knowledge_O Research Approach Data Analysis Experimental Skills Interaction Complexity and Team Work Interaction Frequency Purpose of Interaction Internal : Team Members , Group Leader As and when required Planning work, discussing results of experiments, resolving doubts, for hiring and HR related issues, for reimbursement claims.

Summary The job purpose is to lead and manage all assigned project/network activities and apply scientific/technical expertise to address complex R&D issues for the preparation and timely delivery of drug products (DP), processes and procedures; participate in teams and contribute to overall Technical Research and Development strategies and goals. To develop our growing pipeline of products we are looking for experienced professionals in the area of pharmaceutical development. In this challenging position, you will play a key role in the development of parenteral dosage form. The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD). Role purpose Design, plan, perform, and interpret scientific experiments to perform chemical and pharmaceutical profiling of NCEs resulting in robust analytical method development, solid form characterization and formulation strategy development in collaboration within a multifunctional project team coordinated by a Project leader. Manage and contribute to maintenance of lab instruments/infrastructure. About the Role Major accountabilities: Ensure the selection of the appropriate NCE during discovery and early phase product development by performing appropriate risk assessments using physicochemical characterization, in vitro assessments, and in silico assessments. Design & formulate appropriate pre-clinical PK and tox formulations for parenteral and oral routes. Select, develop, and scaleup appropriate enabling technologies such as nanosuspension, amorphous solid dispersions, or microemulsion development per risk assessed. Design and perform analytical scientific experiments to characterize solubility, dissolution, pH, and permeability for DS and DP. Analysis by UV fiber optics, UPLC/HPLC, and other techniques as required (SEC, IC, Raman, FT-IR, XRPD, DSC, TGA, NMR, etc.). Design, plan and perform scientific experiments to support development of new technologies. Contribute to project related scientific/technical activities either independently or under minimal guidance from more experienced team member. Propose and provide input for the design of next experiments. Generate and evaluate data. Interpret results and document and report result using electronic notebooks(eLN) according to Novartis electronic documentation processes. Author development reports, laboratory protocols, etc. as per need. Communicate and address problems, perform literature searches. Adhere to all health and safety (HSE) practices appropriate to the site and country. Work according to appropriate SOP’s, and Novartis guidelines. Maintain a clean and safe working space. Utilize special tools/equipment and specialized facilities e.g., containment facilities, for potent compounds. Make sure that all deliverables are achieved against agreed project timelines and meeting quality expectations. Contribute to selection, installation, training, and maintenance of equipment and infrastructure. Manage inventory (chemicals, excipients, consumables, and solvents) within own area of responsibility. Evaluation and implementation of new methods and technologies, scientific contributions, supervision of research projects and initiation of new research activities. Enable Novel Delivery Technologies evaluation as per project needs Proactively support the overall culture of the organization through coaching, mentoring, providing feedback, driving innovation, external collaborations, and best practice sharing. Report and present scientific/technical results internally and contribute to peer reviewed publications, presentations, and patents. Fully adhere to all relevant Novartis Policies and Guidelines. Role model the Novartis Values and Behaviors. Minimum Requirements: M. Pharm with 7 to 10 years of experience or PhD in Science with focus on pharmaceutical sciences and technology (e.g. Pharmacy, Chemistry) with 5+ years of experience Experience in the development, scale-up and technology transfer of Parenteral Drug Product manufacturing processes is required. Background in aseptic process development of parenteral product is required Thorough understanding of aseptic fill-finish unit operations (i.e. filling, filtration, mixing, lyophilization etc.) and equipment for scale-down model development and process characterization is required. Experience with regulatory filings (IND/IMPD etc.) is required. Demonstrated competency and experience in drug product development within the pharmaceutical industry is required. Successful work experience in a matrix organization is preferred. Good oral, written (good experience in writing of scientific reports and filing documentation) and presentation skills are essential. 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 Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Role: Formulation Researcher II Work location: Ambernath Role & responsibilities Work on bench with the formulation development teams for the timely achievement of key milestones. Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE. Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data To conduct literature review, prior art experiment design of the product identified for development. Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering. Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic form phase transformation studies, selection of excipients and process as per strategy. Conducting and performing the development trial at bench level, problem identification & resolution. Review and interpretation of analytical data for further action plan. Responsible for execution of Pilot BE batches and interpretation of bio results. Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results. Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE). Establish the stability data for development batches in collaboration with the analytical team. Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report. Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product. Compilation and preparation of pharmaceutical development report with respect to current QbD format. Responsible for preparation of Product Developmental Report (PDR) for filling. Handling of deviations, change control and OOS related to Exhibit batches. Preparation, updating of SOPs. Maintaining of batch, calibration and other necessary records. Subjecting required batches to stability studies. Successful demonstration of proof of concept and ensure prospective documentation in line with QbD paradigm. Discuss and deliberate needful measures for timely execution of batches and ensure regulatory filing, approval and launch of generic drug products. Experience & Qualification: Ph.D. in Pharmaceutical Sciences with 3 Yrs +/ M. Pharm in Pharmaceutical Sciences with 6 to 10 years from reputed universities Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada. Formulation Development of Solid Oral Dosage forms, exposure from development and submision to regulatory agencies. SME within team and Provides solutions to moderate problems within team. Frequent use of scientific theories and principles. Good learning acumen Basic level understanding on recent ICH, regulatory guidelines, IP requirements; understanding of Bioequivalence, GMP, Quality and SOP compliance, GLP etc. Interested candidates can share their CV to ankita.sonawane@teva.co.in Show more Show less

Title: MET-ID Scientist Date: 1 Jun 2025 Job Location: Bangalore Pay Grade Year of Experience: Job Description Job Title: MET ID Scientist 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. Core Purpose Of The Role Bioanalytical scientist with expertise in handling LCMS/MS and support ADME screening assays: InVitro assays, MET ID and large molecule analysis by LCMS and in line with business needs. Role Accountabilities Optimization of test compounds and to develop high throughput, fit for purpose LC-MS/MS and HPLC-UV methods to support ADME samples analysis: Formulations analysis, solubility studies, stability studies, In vitro assays, MET ID and large molecule analysis etc. Perform analysis of samples generated for the screening of compounds for ADME assays and Processing of different matrices/formulation samples of PK studies with no/minimal supervision Excellent written and oral communication skills interacting with internal stakeholders Operation, maintenance and troubleshooting of HPLC/ LC-MS/MS system Preparation of protocols, reports and templates for responsible activities Instrument maintenance, scheduling calibration and maintaining documentation as per regulatory compliance and company policy Adhering to safety and quality policies laid by organization Delivery of quality data with planning, execution of bioanalytical activities within the team in agreeable timelines Development and implementation of high throughput, fit for purpose bioanalytical methods to support invitro ADME samples analysis Identification of problem and trouble shooting in quick turn-around time Mentoring team members to generate quality data within agreed timelines To perform MET ID studies and providing final quality data with interpretation Peptide/ large molecule bioanalysis Coordination with related invitro verticals to plan the bioanalysis in cassette Excellent written and oral communication skills interacting with internal/external stakeholders Operation, maintenance and troubleshooting of HPLC/ LC-MS/MS system Preparation of protocols, reports and templates for responsible activities Instrument maintenance, calibration and maintaining documentation as per regulatory requirements and company policy Adhering to safety and quality policies laid by organization Formulation analysis data review and trouble-shooting for quicker resolution Leadership Capabilities: Should be able to guide/mentor the juniors for trouble-shooting and BA method development issues. Should be able to lead a team of 3 to 4 scientists Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific Requirements For This Role Experience: Minimum 6 to 9 years of relevant industrial experience Demonstrated Capability Hands-on experience in handling of LC-MS/MS systems is mandatory and experience on HRMS is advantageous Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction Comprehensive understanding of in vitro ADME assays and technical expertise in trouble shooting the assay samples analysis. Basic knowledge on Large molecule and Peptides analysis using LCMS/HRMS Should assist/deliver the scientific presentation in departmental journal club and write official Project reports Should be equipped with quality policies related to data management and data integrity Education: M. Pharm in Pharmaceutical sciences/ Relevant master’s degree in pharmaceutical sciences or instrumentation Skills And Capabilities Good communication skills Strong problem-solving and handling skills Team Player Ability to learn/implement new assay in ADME and Analytical Quality compliance skills Behavioral Skills Demonstrate strong people management skills, leading by example with a high level of emotional intelligence, and be willing to work collaboratively with other functional groups. Excellent interpersonal, communication and presentation skills. Ability to lead cross-functional teams and act as a true team player. Ability to discuss and debate data and project strategy with demanding clients and scientific experts. Equal Employment Opportunity 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. Show more Show less

Key Responsibilities: Responsible for calibration of all analytical instruments and preparation/maintenance of rest solutions and reagents. Conduct analysis of development batches, stability samples, and comparative dissolution profiles. Lead analytical method development, validation, and preparation of method development reports. Perform drug solubility studies of active pharmaceutical ingredients and execute API & excipient comparability studies. Monitor temperature and humidity in the stability chamber daily while ensuring proper documentation of Analytical R&D activities. Follow GLP, GDP, safety protocols, and compliance guidelines with the Analytical R&D team. Coordinate with cross-functional teams (CFT) for seamless product development within specified timelines. Execute LER-related activities and oversee analytical method development reports for API and FDF. Analyse scale-up and PO batches while managing document issuance, maintenance, and sample submission for laboratory testing. Requirements: MSc with 2-5 years of experience Strong expertise in analytical method development and validation. Experience in comparative dissolution profile analysis and stability studies. Understanding of GLP, GDP, and compliance requirements. Ability to collaborate effectively with CFTs for smooth development activities. Detail-oriented approach to documentation, monitoring, and reporting Show more Show less

Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview If you want to help pharmaceutical researchers improve the quality of drugs, and you have experience developing analytical methods with quantitative nuclear magnetic resonance (qNMR), then the United States Pharmacopeia (USP) wants to talk with you! We have an immediate opening for a Scientist III in our Digital and Innovation group. This position plays a critical role developing the next-generation analytical and digital technologies for pharmaceutical R&D. The successful applicant will drive product and application development by understanding the technical capabilities of qNMR and quantum mechanics (QM) for chemical analysis, developing validated methods, investigate the potential of non-targeted analysis using solvent solubility and the application of the Life Cycle approach through QbD principles. The successful candidate will also collaborate with on-going studies as appropriate. For over 200 years, USP has worked as an independent, scientific nonprofit organization to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through our rigorous science and the public quality standards we set, USP builds trust in the supply of safe, quality medicines. With USP’s unique mix of rigorous scientific research, exceptional world-wide brand recognition, and a rapidly evolving suite of digital products and services, the successful applicant can make a tangible contribution to USP’s mission of protecting patient safety and improving the health of people around the world. How will YOU create impact here at USP? Duties The position's purpose should provide a high-level overview of why the position exists and briefly identify the most critical priorities of the position. This is an opportunity to highlight any features or duties of the role which includes: Perform studies to evaluate the key parameters of NMR and their impact on QM based analysis and qNMR non-target analysis. Develop, optimize, and publish high-quality analytical methods using high-field NMR and qNMR applications; publications may include white papers, application notes, or journal articles; Acquire high resolution qNMR spectra and implement structural elucidation for obtaining chemical structural information to develop QM spectral analysis models; Collaborate in on-going studies to expand the digital NMR spectral database; Provide sound technical guidance on related product development projects to advance qNMR applications and integrate them within USP Manage project tasks, create appropriate work schedules, and create experiment plans; Troubleshoot and resolve method and instrumentation issues and implement risk-mitigating process controls to ensure high data quality; Review, interpret, and evaluate available scientific literature to assist in the landscaping of both high-field and benchtop qNMR applications in the pharmaceutical, nutraceutical, and foods industries; Collaborate with appropriate internal stakeholders and experts from across academia and industry to drive USP’s mission of developing public standards. 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 MSc./ M. Pharm. having 6-8 years’ experience for S-III in a scientific discipline, with NMR, qNMR and Quantum mechanics along with method development experience. Ph.D. having 1-3 years’ experience for S-III in a scientific discipline, with NMR, qNMR, Quantum mechanics along with method development experience. Experience in performing research towards the development and validation of high-quality analytical methods; Hands-on experience in using NMR (qNMR, quantum mechanics for qNMR modeling and analysis, HPLC, and other appropriate technologies); We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many, though perhaps not all, qualifications are encouraged to apply. Additional Desired Preferences Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration. Capability to plan and conduct rigorous scientific research independently; Skilled in evaluation and interpretation of data; Strong ability to collaborate with various internal and external stakeholders to achieve intended outcomes; Ability to multi-task; Skilled in anticipating, troubleshooting, and solving technical problems; Familiarity and ability to execute good laboratory practices (GLP); Detailed oriented with excellent Organizational and Project Management skills; Excellent communication and presentation skills, both verbal and written; to communicate complex scientific ideas to non-scientists; Takes personal responsibility to ensure work is delivered on time and is of the highest quality; Knowledge in the design, plan and build guidelines for standardizing spectral library/database is a plus; Knowledge of potential applications of spectral libraries is a plus; Understanding of good manufacturing practices (GMP) is a plus. Benefits Supervisory Responsibilities NA 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 & Scientific Standards Job Type Full-Time Show more Show less

Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview If you want to help pharmaceutical researchers improve the quality of drugs, and you have experience developing analytical methods with quantitative nuclear magnetic resonance (qNMR), then the United States Pharmacopeia (USP) wants to talk with you! We have an immediate opening for a Scientist III in our Digital and Innovation group. This position plays a critical role developing the next-generation analytical and digital technologies for pharmaceutical R&D. The successful applicant will drive product and application development by understanding the technical capabilities of qNMR and quantum mechanics (QM) for chemical analysis, developing validated methods, investigate the potential of non-targeted analysis using solvent solubility and the application of the Life Cycle approach through QbD principles. The successful candidate will also collaborate with on-going studies as appropriate. For over 200 years, USP has worked as an independent, scientific nonprofit organization to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through our rigorous science and the public quality standards we set, USP builds trust in the supply of safe, quality medicines. With USP’s unique mix of rigorous scientific research, exceptional world-wide brand recognition, and a rapidly evolving suite of digital products and services, the successful applicant can make a tangible contribution to USP’s mission of protecting patient safety and improving the health of people around the world. How will YOU create impact here at USP? Duties The position's purpose should provide a high-level overview of why the position exists and briefly identify the most critical priorities of the position. This is an opportunity to highlight any features or duties of the role which includes: Perform studies to evaluate the key parameters of NMR and their impact on QM based analysis and qNMR non-target analysis. Develop, optimize, and publish high-quality analytical methods using high-field NMR and qNMR applications; publications may include white papers, application notes, or journal articles; Acquire high resolution qNMR spectra and implement structural elucidation for obtaining chemical structural information to develop QM spectral analysis models; Collaborate in on-going studies to expand the digital NMR spectral database; Provide sound technical guidance on related product development projects to advance qNMR applications and integrate them within USP Manage project tasks, create appropriate work schedules, and create experiment plans; Troubleshoot and resolve method and instrumentation issues and implement risk-mitigating process controls to ensure high data quality; Review, interpret, and evaluate available scientific literature to assist in the landscaping of both high-field and benchtop qNMR applications in the pharmaceutical, nutraceutical, and foods industries; Collaborate with appropriate internal stakeholders and experts from across academia and industry to drive USP’s mission of developing public standards. 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 MSc./ M. Pharm. having 6-8 years’ experience for S-III in a scientific discipline, with NMR, qNMR and Quantum mechanics along with method development experience. Ph.D. having 1-3 years’ experience for S-III in a scientific discipline, with NMR, qNMR, Quantum mechanics along with method development experience. Experience in performing research towards the development and validation of high-quality analytical methods; Hands-on experience in using NMR (qNMR, quantum mechanics for qNMR modeling and analysis, HPLC, and other appropriate technologies); We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many, though perhaps not all, qualifications are encouraged to apply. Additional Desired Preferences Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration. Capability to plan and conduct rigorous scientific research independently; Skilled in evaluation and interpretation of data; Strong ability to collaborate with various internal and external stakeholders to achieve intended outcomes; Ability to multi-task; Skilled in anticipating, troubleshooting, and solving technical problems; Familiarity and ability to execute good laboratory practices (GLP); Detailed oriented with excellent Organizational and Project Management skills; Excellent communication and presentation skills, both verbal and written; to communicate complex scientific ideas to non-scientists; Takes personal responsibility to ensure work is delivered on time and is of the highest quality; Knowledge in the design, plan and build guidelines for standardizing spectral library/database is a plus; Knowledge of potential applications of spectral libraries is a plus; Understanding of good manufacturing practices (GMP) is a plus. Benefits Supervisory Responsibilities NA 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 & Scientific Standards Job Type Full-Time Show more Show less

Summary of Job To be responsible for pre-formulation and preclinical formulation activities. To be responsible for designing the experiment under supervision and handling associated equipment's and operations along with interpretations. Key Responsibilities 1.Ability to design and execute pre-formulation experiments like solubility, pKa, log P, dissolution, intrinsic dissolution, bulk density, flow indices, solid-state assessment, excipient compatibility etc. 2.Completely conversant with hands on experience and/or interpreting data from pre-formulation studies of a compound including physicochemical, bulk, surface and particle properties. 3.Ability to design and execute preclinical formulations to support lead ID, lead optimization and clinical candidate selection, including but not limited to solution, suspension, powder for constitution, compound filled in capsules and basic tablet ability. 4.Reasonably conversant with hands on experience and/or interpreting data from solid-state equipment's like PXRD, MDSC, TG, DVS and other techniques like Polarizing and Hot-stage Microscopy and other dynamic image analysis techniques, specially during supporting solid form and salt screening. 5.An additional benefit would be to have operational experience of handling Particle size analyzer, HPLC, GC, Dissolution apparatus and Disintegration apparatus. 6.Ability to collate and scientifically present data & observations and provide scientific inputs in discussion with internal or external customers. 7.Proactively maintain the equipment's, facility and supporting systems as per established good lab handling processes, maintain requisite equipment and process SOPs and lean tools 8.Follow good documentation practices and have adequate exposure to record observations in Electronic Lab Notebook (ELN). 9.Proactive in aligning with new technologies and approaches to participate in continuous improvement needs of the business. 10.He/she should have sufficient knowledge chemical safety, comprehensive risk assessment of drug substance and safe handling. Qualification M. Pharma, M.Sc. or M Tech with relevant specialization in Pharmaceutical Sciences Experience 1-5 years Key Competencies (Technical, Functional & Behavioral) Technical & Functional Sound experience of fundamentals of pre-formulation and approaches used for preclinical formulation development of compounds. Basic knowledge on developing clinical formulation would be an added plus. Demonstrated capability in having understanding to design and interpret data from PXRD, modulated DSC, TGA, DVS, Microscopy and working operations of HPLC, GC, FT-IR, NMR, Dissolution, BET and other physical and physicochemical characterization techniques. Hands-on operating would be an added plus. Behavioral Aptitude to learn and excel. Proactive in technical & operational space. Ability to work in cross-functional team environment. Ability to contextualize the observations and attention to detailing. Effective communication skills and absorbing attitude.

The Position Organization : - Jubilant Biosys Designation & Level: - Research Associate/ Sr. Research Associate (A3/A4) Location: - Greater Noida Department: - DMPK Key Responsibilities In Vitro ADME studies Read and understand various in vitro ADME protocols Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities Conduct the following in vitro ADME experiments logP, logD, pKa measurements CYP induction and inhibition assays Permeability determinations (Caco-2, MDCK etc) in relevant cell lines CYP phenotyping in purified enzyme systems Solubility determinations (kinetic, thermodynamic, simulated fluids) Bioanalysis : Read and understand the bioanalysis sections in the study protocols LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete) Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory. Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory General LC-MS/MS and HPLC maintenance and troubleshooting Data analysis and report generation: Understand the quality of bioanalytical data Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory Ability to calculate in vitro results/ parameters on excel spreadsheets Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager Generate reports in both GLP and non-GLP formats (based on the requirement) Person Profile Qualification: - M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background) Master in Pharmacy (M.Pharm) Experience: - 2- 6 years of relevant experience. Experience in a drug discovery industry/ CRO in DMPK department. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. Show more Show less

Who We Are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service. Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market. How You’ll Spend Your Day Responsible on-Site product transfer & New Product transfer, scale-up, proposals, Capex evaluations & Process Engineering calculations Improvement in the yield, efficiency and cost effectiveness of developed API’s by introducing new Technologies and further development of process fine tuning Extensive experience in API manufacturing with a deep understanding on Scale-up. Troubleshooting the plant related problems, to overcome the process related difficulties for smooth production Contribute novel ideas by way of participation during technical discussion with superiors/ Colleagues Cycle time reduction, Capacity enhancement and making capacity increase proposals with the support of site CFT members/ leads. Ability to manage 4-5 Engineers coaching, career development and build high performing, engaged and effective teams through motivation and inspiration Person will be expected to support chemistry projects to develop the process engineering knowledge and lead the transfer from lab to scale-up lab and further to production scale Experience on handling CDMO products will be an advantage Person will have demonstrated expertise in the scale-up and process understanding of chemical process unit operations in the manufacture of APIs, intermediates and raw materials. Experience in Quality by Design, process safety, technology transfer and commercial production would be advantageous. Person will be responsible to execute trial and validation batches and support in related activities at plant in the time of scale up In-depth, hands-on expertise and up-to-date knowledge of a wide range of chemistry unit operations such as reactions, distillation, separation, filtration and drying. Strong scientific track record, ability to handle several projects in different stages of development at the same time. Person will be responsible to Investigate and troubleshoot in case of issues in scale up/validation and support troubleshooting activities in case of issues in scale up/validation batches Responsible to use process modelling tools like Dyno Chem, VISMIX for reaction, crystallization, filtration, solubility and mixing studies Good knowledge on solvent recovery & recycle by using latest technologies etc Your Experience And Qualifications B. Tech/ M. Tech Chemical (Regular from reputed Institute) 14-16 Years experience & 5 years in people management Excellent communication skills to interact internally with project teams and externally with customers Good project management and supervisory skills. Collaboration and influencing skills to build partnerships with the other disciplines, similar groups, Conscientious with a can-do attitude and thorough attention to detail. A team player & Competent in the use of key process engineering and modelling software packages Equivalent experience in a Process, Synthetic Chemistry or Manufacturing environment. Experience in working to GMP. Experience in the application of Process Safety to the design of chemical processes Reports To Associate Director, MS&T Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Show more Show less

Role & responsibilities Reverse Engineering of Formulations: Perform reverse engineering of reference-listed drugs (RLDs) and identify composition, excipients, and active ingredients . Utilize advanced analytical techniques for component identification and quantification. Analytical Method Development & Validation: Develop and validate HPLC, UPLC, GC, LC-MS, FTIR, UV, NMR, XRD, and DSC methods for comparative studies. Characterize excipients, degradation products, and impurities in formulations. Comparative Dissolution & Physicochemical Characterization: Conduct comparative dissolution profiling with RLD as per regulatory guidelines. Study particle size, polymorphism, stability, and compatibility of drug formulations. Regulatory Compliance & Documentation: Prepare analytical reports, method validation protocols, and regulatory documents for ANDA, USFDA, MHRA, EU-GMP submissions. Ensure compliance with ICH, USP, EP, JP, and WHO guidelines. Technology Transfer & Troubleshooting: Support technology transfer for scale-up and commercialization. Assist in troubleshooting analytical challenges during formulation development . Key Skills & Competencies: Expertise in HPLC /UPLC / GC / LC-MS / FTIR / NMR/ XRD/ DSC Knowledge of polymorphism, solubility, permeability, and excipient compatibility Experience in reverse engineering & impurity profiling Strong understanding of ICH Q2 (R1), USFDA, and regulatory guidelines Hands-on experience in GMP, GLP, and stability studies Preferred candidate profile M. Pharmacy / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry / Organic Chemistry) Perks and benefits As Per Company Policy