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analytical development scientist

Azurity Pharmaceuticals

<div>
 Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company&rsquo;s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
 
 
 Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
 
 
 
 Brief Team/department Description
 
 
 
 The Analytical Development department in the science organization at Azurity Pharmaceuticals is responsible for developing new analytical methods for the new dosage forms to ensure their quality.
 
 
 
 Principal Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for the development of analytical methods for product development, primarily for sterile dosage forms and/or oral dosage forms.
 </li>
 <li>
 Responsible for the preparation of method development reports, validation protocols and reports, and test methods.
 </li>
 <li>
 Accountable for performing routine analytical testing for assigned projects, as per requirements.
 </li>
 <li>
 Responsible for executing Analytical ATR (Analytical Testing Reports), documenting results, and sharing findings with the concerned formulation development (FD) team.
 </li>
 <li>
 Accountable for the calibration of assigned equipment, qualification of working standards, and maintenance of standards per storage conditions.
 </li>
 <li>
 Responsible for conducting forced degradation studies and identifying unknown impurities.
 </li>
 <li>
 Responsible for executing experiments to address and respond to regulatory queries.
 
 
 </li>
 </ul>
 
 Qualifications And Education Requirements
 
 
 
 <ul>
 <li>
 6-8 years of experience in Analytical Development of Formulation
 </li>
 <li>
 M. Pharm or MSc Chemistry
 
 
 </li>
 </ul>
 By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
</div>

Analytical Development Scientist

US Pharmacopeia

<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
 
 
 
 This is an independent contributor scientific position in the Small Molecules Department (SM) reports to the Sr. Manager. The successful candidate will be responsible for creating, managing chemical structure files based on sponsor submission data to support the development of monographs for drug substances and associated dosage forms in the USP-NF. This role requires active communication with Small Molecules and other PUTs, Reference Standards Scientists, GSRS team, Reference Standards Laboratories (RSL), and Analytical Development Laboratories (ADL) and other departments such as Publications (PUBS), SCD, Procurement 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 Sr. Scientist I/II Has The Following Responsibilities
 
 
 
 <ul>
 <li>
 Create and update chemical information files based on data submitted by external collaborators and sponsors.
 </li>
 <li>
 Review and validate chemical data for accuracy, consistency, and compliance with internal standards.
 </li>
 <li>
 Edit and manage chemical information using the GSRS platform and Excel-based tools.
 </li>
 <li>
 Collaborate with a team of scientists to support the development and continuous improvement of chemical information files.
 </li>
 <li>
 Utilize cheminformatics software (e.g., ChemDraw, ISIS) for developing chemical structures and other chemical information.
 </li>
 <li>
 Conduct comprehensive searches using chemical databases and tools such as SciFinder, ChemSpider, USAN, INN, and PubMed.
 </li>
 <li>
 Support literature and patent research using platforms like Reaxys and PubChem.
 </li>
 <li>
 Work closely with IT and data science teams to integrate chemical information systems with enterprise data platforms.
 </li>
 <li>
 Engage with USP staff, regulatory bodies, stakeholders, and other pharmacopeias to support monograph development.
 </li>
 <li>
 Collaborate with internal departments including Reference Standards Development (RSD), Analytical Development Laboratories (ADL), Publications, and Compendial Operations on monograph-related initiatives.
 </li>
 <li>
 Experience working with biologic molecules and excipients is a strong plus.
 </li>
 <li>
 Strong communication and collaboration skills across scientific and technical teams.
 </li>
 <li>
 Familiarity with regulatory and pharmacopeial standards and processes.
 </li>
 <li>
 Participate in cross-functional teams and contribute to strategic initiatives.
 </li>
 <li>
 Perform additional duties as assigned to support departmental goals.
 
 
 </li>
 </ul>
 
 Who is USP Looking For?
 
 
 
 
 Experience Required
 
 
 
 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:
 
 
 Senior Scientist I: MSc - Organic Chemistry with minimum 11 to 13 years relevant experience; or Ph.D. degree in Organic Chemistry, or a related scientific field with 7 to 10 years.
 
 
 Senior Scientist II: MSc - Organic Chemistry with minimum 13 to 15 years relevant experience; or Ph.D. degree in Organic Chemistry, or a related scientific field with 10 to 13 years
 
 
 
 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.
 
 
 <ul>
 <li>
 Expert in naming organic compounds using the IUPAC naming convention
 </li>
 <li>
 Broad knowledge of organic chemistry and chemical reactions
 </li>
 <li>
 Experience using the United States Pharmacopeia or other global pharmacopieas is a plus.
 </li>
 <li>
 Experience with the Global Substance Registration System is a plus
 </li>
 <li>
 Previous experience working in the Pharmaceutical Industry is a plus
 </li>
 <li>
 Expertise in the degradation chemistry of organic compounds is a plus.
 
 
 </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.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Senior Scientist I/II, Documentary Standards (Synthetic Chemical Information)

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

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

<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

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 highly skilled Analytical Scientist in to join our Research and Development team for Injectable Division for developing and validating analytical methods for injectable products, ensuring compliance with the regulatory requirements, conducting literature reviews, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. This role demands a strong understanding of analytical principles, excellent documentation skills, and the ability to work effectively in a collaborative team environment. scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer.
 
 
 
 
 
 Roles &amp; Responsibilities
 
 
 
 
 <ul>
 <li>
 You will be responsible Analytical method development and validation of injectable products.
 </li>
 <li>
 You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field.
 </li>
 <li>
 You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department.
 </li>
 <li>
 You will be responsible to execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team.
 </li>
 <li>
 You will be responsible for analytical method development for drug products for various tests mentioned in the specification in order to analyse the product development batches for the prototype screening.
 </li>
 <li>
 You will be responsible for analytical method validation activities at the manufacturing sites providing method development reports to verify the validation parameters and ensure the execution of method validation as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing.
 </li>
 <li>
 You will be responsible for analytical method transfer to plant locations successfully in order to train the Quality Control (QC) team on the methods for the Exhibit and commercial batch analysis at plant.
 </li>
 <li>
 You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results.
 </li>
 <li>
 You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy.
 </li>
 <li>
 You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions.
 </li>
 <li>
 You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 
 Educational qualification:
 
 Masters in Science/ Organic chemistry/ Pharmaceutical Sciences
 
 
 
 
 
 Minimum work experience:
 
 5 years of experience in analytical method development
 
 
 
 
 
 Skills &amp; attributes:
 
 
 
 
 
 
 Technical Skills
 
 
 
 
 <ul>
 <li>
 Extensive work experience in analytical method development and validation of injectable products.
 </li>
 <li>
 Proven experience with injectable, ophthalmic, peptide, and suspension products.
 </li>
 <li>
 Demonstrated expertise in sameness and characterization studies for complex molecules.
 </li>
 <li>
 Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.
 </li>
 <li>
 Advanced skills in troubleshooting analytical methods and instruments.
 </li>
 <li>
 Comprehensive understanding of Abbreviated New Drug Application (ANDA) filing requirements.
 </li>
 <li>
 Strong knowledge of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
 </li>
 <li>
 Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.
 </li>
 <li>
 Familiarity with Quality by Design (QbD) principles and their application in analytical method development.
 </li>
 <li>
 Experience with stability testing and forced degradation studies for injectable products.
 </li>
 <li>
 Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.
 </li>
 </ul>
 
 
 Behavioral Skills
 
 
 
 
 <ul>
 <li>
 Strong analytical and problem-solving abilities, with a keen attention to detail
 </li>
 <li>
 Excellent communication and interpersonal skills, with the ability to effectively present complex analytical data to diverse audiences..
 </li>
 <li>
 Ability to work collaboratively with own team and cross-functional teams in a fast-paced environment.
 </li>
 <li>
 Demonstrated project management skills and ability to handle multiple projects simultaneously.
 </li>
 <li>
 Adaptability and willingness to learn new techniques and methodologies.
 </li>
 <li>
 Strong commitment to safety protocols and environmental regulations in laboratory settings.
 </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/#!/
 
 
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Analytical Scientist Injectable

Amazon

<div>
 
 Description
 
 
 
 Have you ever thought about what it takes to detect and prevent fraudulent activity in hundreds of millions of eCommerce transactions across the globe? What would you do to increase trust in an online marketplace where millions of buyers and sellers transact? How would you build systems that evolve over time to proactively identify and neutralize new and emerging fraud threats?
 
 
 Our mission in Buyer Risk Prevention (BRP) is to make Amazon.com the safest place to transact online. BRP safeguards every financial transaction across all Amazon sites, while striving to ensure that these efforts are transparent to our legitimate customers. As such, BRP designs and builds the software systems, risk models and operational processes that minimize risk and maximize trust in Amazon.com.
 
 
 As a Risk Analyst in BRP, you will be responsible for analyzing terabytes of data to identify specific instances of risk, broader risk trends and points of customer friction. You will develop scalable solutions for fraud prevention. In addition, you will be responsible for building a robust set of operational and business metrics and will utilize metrics to determine improvement opportunities.
 
 
 Key job responsibilities
 
 
 Perform complex data analysis to proactively generate actionable insights
 
 
 Own the design, development, and maintenance of ongoing metrics, reports, analyses, dashboards, etc. within SQL and other BI tools
 
 
 Design and implement various visual dashboards in order to make insights available to team members, stakeholders and our customers
 
 
 Support cross-functional teams on the day-to-day execution of projects and initiatives
 
 
 Enable effective decision making by retrieving and aggregating data from multiple sources and compiling it into a digestible and actionable format
 
 
 Preparing and delivering business reviews to the senior management team regarding progress and roadblocks
 
 
 Communicate complex analysis and insights to stakeholders and business leaders, both verbally and in writing
 
 
 A day in the life
 
 
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 Review instances of fraud and create mechanisms to stop them
 </li>
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 Report on fraud trends and improve products
 </li>
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 Create and maintain dashboards that detect and inform stakeholders (such as payment product owners) on how to stop fraud
 
 
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 </ul>
 
 About The Team
 
 
 
 Our team consists of Business Analysts, Data Scientists, Business Intelligence Engineers and Applied Scientist rolling under the core Buyer Risk Prevention Machine Learning Team. We evaluate instances of organized buyer fraud attacks on Amazon platform WW across various payment methods. We collaborate closely across multiple functions in order to mitigate these attacks through various short and long term solutions.
 
 
 
 Basic Qualifications
 
 
 
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 <li>
 1+ years of experience in financial/business analysis
 </li>
 <li>
 Experience with SQL/ETL and Python
 </li>
 <li>
 Experience defining requirements and using data and metrics to draw business insights
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or Master's Degree in any quantitative discipline such as Statistics, Mathematics or Economics 2. Proven experience in working with large scale databases and SQL in a business environment
 </li>
 <li>
 Demonstrated experience using scripting languages like Python
 </li>
 <li>
 Hands-on experience applying machine learning algorithms and statistical methods in a business environment
 
 
 </li>
 </ul>
 Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you&rsquo;re applying in isn&rsquo;t listed, please contact your Recruiting Partner.
 
 
 
 
 Company
 
 - ADCI HYD 20 SEZ
 
 
 Job ID: A3046681
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Risk Analyst, Buyer Risk Prevention, Payment Risk Mining

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