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7.0 - 12.0 years
4 - 9 Lacs
Vadodara
Work from Office
Department: ADL Experience: 5+ Years Qualification: M.Sc. (Analytical Chemistry) Location: Vadodara Job Description: We are looking for an experienced Executive in the Analytical Development Laboratory (ADL) to support R&D activities. The role involves method development, validation, analytical testing, and ensuring regulatory compliance of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for pharmaceutical substances and products. Conduct analytical testing using HPLC, GC, UV, Mass Spectrometry, etc . Troubleshoot analytical issues and ensure data accuracy and reliability. Adhere to quality control protocols and support audits (Customer/Regulatory). Maintain and calibrate lab instruments and stay updated with new analytical technologies. Follow QMS, SOPs, and safety standards. Skills Required: Strong knowledge of analytical chemistry techniques. Experience in pharmaceutical R&D. Good documentation and communication skills.
Posted 11 hours ago
5.0 - 7.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.
Posted 12 hours ago
5.0 - 10.0 years
10 - 14 Lacs
Vapi
Work from Office
The Analytical Development Scientist-I with some supervision from the Analytical Development Lead focuses on the analysis of route scouting and Chemical Process Development of Bayers' existing and pipeline crop protective agents Collaborates with all internal and external functional teams, The job holders ensure all the analytical work is done following the highest safety standards with GLP and document the generated data The applicant will have an excellent practical and theoretical understanding of analytical chemistry or a relevant technology and can design and execute high-quality, thoughtful outcomes by analyzing different experiments while making significant contributions both independently and as a member of a team The candidate will work within an interdisciplinary and cross-divisional team in the Crop Protection Innovation organization, TASKS AND RESPONSIBILITIES: Method development for new entities and in-process on GC, GC-MS, HPLC, and various analytical techniques, Analyze and solve complex analytical problems and challenges daily using different instruments and wet chemistry, Document analytical data to support product development and registration, Write analytical laboratory-related Standard Operating Procedures (SOPs)/test methods, To calibrate and maintain instruments and analytical development laboratory with all aspects, Participation in internal/external inspection/audit preparations and documentation, Ability to prioritize and manage numerous activities simultaneously, to ensure timely delivery of analytical objectives, KEY WORKING RELATIONS: Internal Coordinate with ADL team members as well as synthesis chemistry lab for analytical development-related activities, Co-ordinate with site QC and GMP team for analytical development-related activities, External Coordinate with various vendors and engineers for instrument installation/maintenance activities WHO YOU ARE: Sc/ Mpharm in Analytical/Organic Chemistry with more than 5 yearsexperience Deep understanding of analytical tools and supporting software like Empower, OpenLab CDS, and LabSolutions And Chromeleon Strong problem-solving skills with the ability to do structure elucidation, Demonstrated ability to work within a dynamic and interdisciplinary environment to achieve results High assertiveness enjoys working as an individual contributor in a team, Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects in a multi-disciplinary international team Embraces ambitious goals and drives progress with urgency, Consistently seeking opportunities to acquire knowledge, develop skills, and share insights, Possesses a strong willingness to learn and grow through challenging experiences, actively engaging in giving and receiving constructive feedback to foster continuous improvement, Effectively interacts with diverse teams across functions, cultivating strong working relationships with both internal and external collaborators to enhance overall performance Ability to work in the shifts
Posted 1 day ago
2.0 - 5.0 years
2 - 3 Lacs
Vadodara
Work from Office
Analytical Development Laboratory Associate Male Min 2-5 Exp only API Co Salary: 2-3 LPA Location: Vadodara( Nandesari ), Gujrat
Posted 3 days ago
9.0 - 14.0 years
40 - 45 Lacs
Nashik
Work from Office
Product Formulation & Development Cost Optimization ; Raw Material Sourcing No. of new products developed and launched annually (Emulsions / Textures) Raw material cost reduction. Complaint resolution rate (Post-launch performance stability)
Posted 5 days ago
1.0 - 5.0 years
1 - 3 Lacs
Nagpur
Work from Office
Hiring - ADL (AMD) - Nagpur Location Location - Nagpur MH Company - Pharma (MNC) Core OSD Formulation + Method Validation Experience Msc or Mpharm /bpharma Responsibility - Sr. Role Description 1. Analytical Method Development New analytical method development and troubleshooting of existing method of different types of Oral solids dosage form (Granules, Tablets, Pellets, Capsules etc.) for Regulated market projects or as per business need. 1. Ensure robust & cost effective method development of product by considering the available facility & resources 2. Conduct Literature survey, different pharmacopoeia & pharmacopeia forum search and review & application of same in AMD. 3. Conduct Pre-formulation studies (API characterization and Drug-Excipients compatibility studies). 4. Operation and calibration of different analytical instruments. 5. Take into account existing QC facility while developing any product for successful method transfer. 6. Analytical method validation and method transfer activity. 7. Maintain the Good Laboratory practices, Good Documentation practice and Good hygiene practices. 8. Prepare for all type of internal and external audit/inspection. 2. Stability Studies of R&D Products 1. Responsible for stability studies of new R & D products for Regulated market projects. 2. Responsible for interpretation of stability data of the products related to analytical methods. 3. Observations of stability trend and discussion of same with formulation team. 4. Management of stability batches analysis and take the decision for stability studies of different batches as per requirement. 3. Routine Support to F&D Team 1. Responsible for providing routine support for the new product development for regulated market projects. 2. Planning and execution of routine batches analysis in minimum possible time. 3. Analytical data review and to provide the online results and observations to F&D Team. 4. GLP, GDP and Documentation Support 1. Responsible for maintaining the overall GLP and GDP in the Laboratory and providing overall GLP support during day to day activities. 2. Maintenance of working standards, Impurities and reference standards 3. Responsible for preparation, review and approvals of all the documents generating in the ARDL laboratory. 5. Team Building 1. Ensure continuous training and up-gradation of knowledge of the R&D team so that they are at the cutting edge of technology. 2. Set challenging goals for team members to ensure they deliver as per their true potential & as per the need of organization. 3. Identify & nurture the top talent of team. 4. Arrange a monthly interaction with team members to understand & resolve their performance bottle necks & also give them feedback for course correction. Performing any other responsibility as per the requirement, in the larger interest of organization. Interested!!!Please share your cv at Neetij@selectsourceintl.com Thanks & Regards
Posted 6 days ago
1.0 - 6.0 years
3 - 8 Lacs
Bengaluru
Work from Office
We invite Postgraduates and Ph.D. holders to participate in our Walk-in Drive and become a valued part of the Althera family. Please carry a copy of the following documents with you: Updated Resume Recent Payslips/Increment letter and appointment letter Relieving Letter (if applicable) Educational Qualification Certificates We look forward to meeting talented professionals like you. Join us and take the next step in your career with Althera! Roles and Responsibilities Candidate should be very strong in Method development on HPLC for assay, Relates substances & dissolution for Regulated and Semi-regulated markets for tablets & capsules. Should have knowledge on Analytical Method Validation Analytical Method Transfer. Well versed with Regulatory guidelines (ICH and EU). The candidate should be ready to work full time in the lab. Desired Candidate Profile Masters degree or Phd in Pharmacy or Chemistry 1 to 6 years of experience in Solid dosage forms or experience in Peptides (Injectable and solid dosage form). Handling of instruments like HPLC, Dissolution apparatus, UV-VIS spectrophotometers etc. Understand the ICH and other guidelines Preparation and review of Department SOPs. Good knowledge on analytical method development, validations, transfer, stability analysis etc. Candidates from Testing labs can also apply.
Posted 1 week ago
2.0 - 4.0 years
1 - 3 Lacs
Savli, Vadodara
Work from Office
Role & responsibilities Analysis of Routine and Stability samples using instruments like HPLC , UHPLC (Shimadzu), GC.UV spectrophotometer, IR, KF titrator and Dissolution tester. Having Experience in handling of Instruments, Like Analytical Balance, pH meter, KF Titrator, UV spectrophotometer, HPLC, UHPLC, Dissolution tester, GC is preferable Perform Calibration of instruments or equipment Like HPLC, Dissolution. Understanding of wet chemical analysis like: Titration, LOD, KF , IR, UV etc. Maintain analytical documentation records and online documentation of experiments. Understanding of analytical method development Activity. Execute routine Analytical research activities of drug products Follow GLP and safety in the laboratory as per regulatory guidelines. Responsible for any other assignment allocated by the Department Head.
Posted 1 week ago
5.0 - 10.0 years
7 - 12 Lacs
Vadodara
Work from Office
Experience in routine Analysis, Calibration, Analytical Method Development & Validation, Hands on experience over various analytical instruments like HPLC & GC, Documentation as per regulatory requirement.
Posted 1 week ago
6.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on delivering unique, accessible, and high-quality medications, Azurity utilizes its integrated capabilities and extensive partner network to continuously broaden its diverse commercial product portfolio and robust late-stage pipeline. The company's patient-centric products encompass various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. For more information, please visit www.azurity.com. Azurity Pharmaceuticals takes pride in fostering an inclusive workplace environment and is committed to being an Equal Opportunity Employer. The success of Azurity is attributed to its exceptionally talented and dedicated team, which is driven by the mission of enhancing patients" lives through a combination of cutting-edge science and unwavering commitment to quality. We are looking for individuals who are highly motivated, possess integrity, and embody a creative spirit to excel in our organization. The Analytical Development department within the science organization at Azurity Pharmaceuticals plays a crucial role in developing new analytical methods for novel dosage forms to ensure product quality. Responsibilities: - Develop analytical methods for product development, primarily focusing on sterile dosage forms and/or oral dosage forms. - Prepare method development reports, validation protocols and reports, as well as test methods. - Perform routine analytical testing for assigned projects according to requirements. - Execute Analytical ATR (Analytical Testing Reports), document results, and communicate findings to the relevant formulation development (FD) team. - Calibrate assigned equipment, qualify working standards, and maintain standards based on storage conditions. - Conduct forced degradation studies and identify unknown impurities. - Conduct experiments to address and respond to regulatory queries. Qualifications And Education Requirements: - 6-8 years of experience in Analytical Development of Formulation. - M. Pharm or MSc in Chemistry. By applying for this role, you confirm that you possess the mental and physical capabilities necessary to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,
Posted 2 weeks ago
5.0 - 6.0 years
5 - 6 Lacs
Tarapur
Work from Office
Role & responsibilities 1. Good Knowladge about wet lab analysis. 2. Responsible for QC reviewer. 3. Reviewer in LAB solution, LAB-India software, CDS software, IR, UV, TLC. 4. Knowladge about GC analysis. 5. Responsible for analysis of raw material, finish products, intermediates RM/PM/Finished COA's etc. Preferred candidate profile Candidate preferred pharmaceuticals API manufacturing background. USFAD approved plant background would be advantage.
Posted 2 weeks ago
4.0 - 8.0 years
4 - 6 Lacs
Vadodara
Work from Office
Position Title: Team Member Analytical Development Lab Department: Analytical Development Lab Location: Vadodara Reports To: Sr Manager - Analytical Development Lab Job Overview: The Team Member - Analytical supports the transfer and validation of analytical methods from R&D or third-party laboratories to manufacturing or testing environments. This role ensures smooth method transfer, compliance with regulatory standards, and effective collaboration with cross-functional teams to maintain the accuracy and reliability of testing methods. Key Responsibilities: Method Transfer Support: Assist in transferring analytical methods from R&D or third-party laboratories and setting them up on new equipment. Ensure smooth implementation of methods at the receiving site. Method Validation: Participate in the validation of analytical methods to ensure they meet standards for accuracy, precision, and reproducibility. Support the execution and documentation of validation studies. Documentation: Maintain and review method transfer and validation documentation to ensure completeness and regulatory compliance. Ensure records are accurate and ready for audits or inspections. Training: Support the training of laboratory staff on transferred methods, equipment usage, and best practices. Troubleshooting: Assist in resolving issues related to method performance or equipment functionality during the transfer process. Collaboration: Work closely with R&D, Quality Control (QC), Quality Assurance (QA), and Manufacturing teams to ensure seamless method transfer and address challenges effectively. Compliance: Ensure all transferred and validated methods comply with regulatory standards such as GMP, ICH, and other relevant guidelines. Reporting: Assist in preparing detailed reports on validation and transfer outcomes, including data analysis and findings. Key Skills: Technical Skills: Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and related methods. Strong understanding of method validation principles and regulatory standards. Experience with troubleshooting analytical methods and equipment. Soft Skills: Excellent attention to detail and organizational skills. Strong communication and teamwork abilities for effective collaboration with cross-functional teams. Analytical thinking and problem-solving skills to address method transfer challenges. Qualifications & Experience: Education: Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. Experience: 4-7 years of experience in analytical chemistry, method development, validation, or related fields, preferably in pharmaceutical or biotech industries.
Posted 2 weeks ago
2.0 - 5.0 years
1 - 4 Lacs
Ahmedabad
Work from Office
Unison Pharmaceuticals is urgently seeking talented Analytical Development Lab - Routine Analysts for OSD R&D team. Apply now to become a part of a growing team!! Experience: 2 to 5 years Job Role: ADL - Sample Analyst Markets: Domestic & Regulatory both Designation: Officer / Sr. Officer Location: Moraiya, Ahmedabad (Transportation is available from specific routes of Ahmedabad) No. of vacancies: 02 Roles and Responsibilities : Perform chemical, physicochemical and wet analysis as per product requirements. Routine In-process, Finished product (Initial & Stability samples) analysis. Data reporting with good documentation practice and presenting results in informative report format Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen Facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Interested one can share updated resume on career@unisonpharmaceuticals.com to be considered for this role. Join our team and take the first step towards a rewarding career!! Regards, Team HR Unison Pharmaceuticals Pvt Ltd
Posted 2 weeks ago
3.0 - 7.0 years
4 - 7 Lacs
Hyderabad
Work from Office
Role & responsibilities Regular & development Analytical support for R&D projects Method development using HPLC & GC Should Handle Instruments (HPLC, GC, IR, UV, KF & Potentiometer) independently. Preferred candidate profile Exposure to handle analytical equipments like GC, HPLC, KF, Potentiometer, IR & UV. Basic knowledge on ICH guidelines. Good Development Knowledge Awareness of Industry practices in Analytical domain. Basic regulatory knowledge.
Posted 2 weeks ago
3.0 - 5.0 years
8 - 12 Lacs
Mangaluru
Work from Office
We are seeking to hire an innovative and highly motivated Formulation Scientist to join our Biologics RD team . The qualified individual will have at least 3-5 years of relevant industry working experience in developing parenteral formulation, solid and liquid oral dosage forms for use in first-in-human studies. The Formulation Scientist in the Large Molecule Drug Product Development will be a lab-based role, responsible for experimental studies in the pre-formulation, formulation, characterization, and analytical development of therapeutic proteins including monoclonal antibodies, virus-like particles, RNA therapeutics, and subunit-based vaccines. Since most of our clients are based out of USA and Europe, we expect candidates to have some exposure working on international projects. Major Duties and Responsibilities: Develop formulations for parenteral/ injectable and oral drug products. Develop parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody-drug conjugates, proteins, and vaccines. Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and apply this information to develop an appropriate dosage form to meet clinical needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), and imaged Capillary Electrophoresis (iCE). Evaluates feasibility of analytical methods to support product characterization, formulation stability, and compatibility testing. Rational formulation design/selection and characterization studies relevant to the stage of development. Development and optimization of liquid and lyophilized biologics formulations. Design and execute compatibility studies to support the administration of large molecules Design and manage stability studies on target and experimental formulations Perform her/his duties consistent with good laboratory practices Preferred qualifications: Knowledge of protein science, including biochemical, immunological, and biophysical characterization. Knowledge and experience in the development of large molecule formulation. Familiarity with biochemical, biophysical, and/or analytical methodologies for characterization of proteins and peptides. Hands-on experience and trouble-shooting proficiency with column chromatography (SEC, IEX, RP, HIC), biophysical characterization (DLS, DSC, DSF, fluorescence, EM), capillary electrophoresis (CE-SDS, cIEF, iCE), charge variant analysis, oxidation analysis, and peptide mapping for protein characterization are highly desirable. Required qualifications: Ph.D. + > 3 years experience, M.S. + > 5 years experience, or B.S. + > 8 years experience in an appropriate scientific discipline is required. Strong scientific understanding and extensive research experience is necessary. Experiences in the areas of formulation/drug product development, biophysical/biochemical characterization, analytical method development for mAb or recombinant protein-based biotherapeutics and pharmaceutical development are desirable Ability to interpret and analyze data from biophysical assays and design appropriate experiments. Demonstrated experience delivering high quality and timely data while adhering to compliance and data integrity requirements Self-motivated, attention to details, excellent teamwork, organization, oral/written communication skills are highly desirable
Posted 3 weeks ago
1.0 - 3.0 years
2 - 5 Lacs
Mangaluru
Work from Office
We are seeking to hire an innovative and highly motivated Research Associate for our Biologics RD team for our Mangalore lab. The qualified individual will have at least 1-3 years of relevant industry working experience in developing parenteral formulation, solid and liquid oral dosage forms for use in first-in-human studies. This is a highly collaborative role, that provides support to multiple project and senior scientist in a given day. The Research associate will be a lab-based role, will be working in pre-formulation, formulation, characterization, and analytical development of therapeutic proteins including monoclonal antibodies, virus-like particles, RNA therapeutics, and subunit-based vaccines. Since most of our clients are based out of USA and Europe, it is desirable that candidates to have some exposure working on international projects. Major Duties and Responsibilities Performing sample preparation steps which may include sample pipetting with a high degree of accuracy and precision Performing reagent and material preparation for testing Calibrating and maintaining all assigned laboratory equipment and instruments according to standard operating procedures to ensure quality results Maintain adequate inventory of supplies, reagents and materials needed for testing Document remedial action, troubleshooting, quality assurance activities and instrument maintenance Adhere to established processing timelines Perform cleaning and maintenance duties for laboratory spaces and instrumentation Retrieve and catalog samples for testing Properly store samples for short term and long-term storage Adhere to all quality and safety standards, as well as ensuring compliance with all applicable regulatory agencies Adhere to policies and protocols in the lab Disposes of bio hazardous materials, chemical waste, sharp and other potentially hazardous materials according to regulations Review daily run documentation for completeness and accuracy with provided reviewer guidelines Work closely and communicate with other lab associates to complete daily activities efficiently Other duties as assigned by reporting manager. Required Qualification Masters in Biotech/Biochemistry/ any related. Minimum of 1-3 years of experience working in similar field. Self-motivated, attention to details, excellent oral/written skills.
Posted 3 weeks ago
1.0 - 6.0 years
3 - 8 Lacs
Navi Mumbai, India
Work from Office
Job Title: Research Associate Department/Function: BRL Reporting To: DGM Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working Job Summary: Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for all markets. Deliverables involves, but not limited to Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation and Characterization activities. Responsible for independent planning and execution of experiments. Techniques include, but not limited to Chromatography, Electrophoresis, Spectrophotometric-Colorimetric assays and Higher order characterization for Biotherapeutics. Required Skillsets: Knowledge and hands-on experience of different chromatography modes like RP, HIC, IEX, SEC, etc is required. Preferred to have some working knowledge of biosimilars. The following are considered strong assets: Manufacturing industry experience, JAVA stacks experience. Maintain effective and cooperative working relationships with administrators, staff, users, project consultants. Good to have : Integration with Non SAP systems via RestAPI, SOAP API , SFTP etc. Experience Required: Experience of working on biotherapeutic proteins like Cytokines, Fc fusion peptides/proteins and/or Monoclonal antibodies is required Method Development and/or routine analytical support experience with biosimilars is a must Understanding of analytical deliverables involving CQA, QTPP, Biosimilarity, Forced degradation studies, Specifications setting, etc. is preferred. Accountability: To perform assigned analytical activities by following established systems and procedures. To maintain target dates for analytical activities. To maintain data integrity during analysis. Preparation and review of reports and contribution in troubleshooting efforts required for Instrumentation Communicate effectively with other team members and teams regarding the analytical data. Education: Min. Qualification Required - M.Sc. / M.Tech. - Biotechnology / Microbiology Experience: Minimum 6 months- 2 years
Posted 3 weeks ago
1.0 - 5.0 years
2 - 6 Lacs
Vadodara
Work from Office
Company Name: Oneiro Lifecare Pvt Ltd Location: Ekalbara Designation: QC Chemist/Officer/Sr Officer Job description (JD): Qualification: Masters (Chemistry) Candidate should have following criteria: 1] Experience of 1-6years in ADL / QC. 2] Handling instruments like HPLC and GC-Headspace. 3] Handling other analytical instruments like KF-Titrator, Auto-Titrator, pH-meter, Polarimeter, UV Spectrophotometer, Balance etc. 4] Analysis of In-process monitoring, Raw material, Intermediates, Stability studies and Drug substances (API). 5] Analytical method development and analytical method validation exposure. 6] Calibration of analytical instruments 7] Should follow GLP practices, Document preparation for Specifications, SOPs, Certificate of analysis and technical reports. Note: Candidate should be willing to work in shifts and across multiple locations as per organizational needs.
Posted 3 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Jadcherla
Work from Office
Analytical Method Development & Validation : Develop and validate analytical methods for assay, dissolution, related substances, and content uniformity as per ICH guidelines. Troubleshoot and optimize analytical methods for new and existing OSD products (tablets, capsules, etc.). Routine Analysis & Documentation : Conduct analysis of raw materials, in-process samples, and finished products. Prepare and review protocols, reports, method validation documents, and specifications. Stability Studies : Execute and monitor stability studies as per ICH guidelines. Generate stability data and interpret results to support product registration. Instrumentation Handling : Operate and maintain sophisticated analytical instruments like HPLC, UV, FTIR, Dissolution Apparatus, GC, etc. Ensure proper calibration and upkeep of instruments. Regulatory Compliance : Ensure all analytical activities comply with GLP/GMP and regulatory requirements. Support regulatory submissions (ANDA, CTD, eCTD) with analytical documentation. Cross-functional Support : Collaborate with formulation, regulatory, QA, and production teams to support product development lifecycle. Participate in technology transfer and scale-up activities. Key Skills : Sound knowledge of analytical chemistry and pharmaceutical analysis. Hands-on experience with HPLC/GC/UV and dissolution testing. Familiarity with ICH guidelines and regulatory requirements for US/EU/ROW markets. Good documentation practices and data integrity awareness. Ability to work in a fast-paced, cross-functional environment.
Posted 3 weeks ago
1.0 - 4.0 years
1 - 4 Lacs
Vadodara, Gujarat
Work from Office
ADL hands on experience Exposure / Knowledge of HPLC and GC
Posted 3 weeks ago
3.0 - 6.0 years
10 - 20 Lacs
Hyderabad
Work from Office
To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause. To use Rubrics template for investigation report writing. To provide appropriate support to site in preparing for or during regulatory inspection for investigations. Qualification looking someone with strong QC investigation background, QC Compliance, Analytical development Education :B.Pharm, M.Sc, M.Pharm Exp : 8-10 Years Industry : OSD preferred/ Injectable, API also work Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & 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’s why they come to work every day and they’ll say, because Good Health Can’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’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/#!/
Posted 4 weeks ago
5.0 - 10.0 years
3 - 8 Lacs
Gurugram
Hybrid
We are looking for a skilled R&D (Analytical Development LAB) Professional with 5-11 years of experience to join our team. The ideal candidate will have a strong background in analytical development and laboratory techniques. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance laboratory efficiency. Conduct experiments and analyze data to draw meaningful conclusions and recommendations. Collaborate with cross-functional teams to design and develop new products and processes. Troubleshoot and resolve technical issues related to analytical equipment and techniques. Maintain accurate records and reports of experimental results and findings. Stay updated with industry trends and advancements in analytical technology. Job Requirements Strong knowledge of analytical techniques such as HPLC, GC, and Spectrophotometry. Experience with laboratory software and instrumentation is required. Excellent problem-solving and critical thinking skills are essential. Ability to work independently and collaboratively as part of a team. Strong communication and interpersonal skills are necessary. Familiarity with regulatory requirements and quality control procedures is expected.
Posted 4 weeks ago
4.0 - 9.0 years
3 - 8 Lacs
Bharuch
Work from Office
We are looking for a skilled R & D (Analytical Development) Professional with 4 to 9 years of experience to join our team. The ideal candidate will have a strong background in analytical development and excellent problem-solving skills. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance product quality. Collaborate with cross-functional teams to design and execute experiments and tests. Analyze data and results to identify trends and areas for improvement. Design and develop new products and processes using analytical techniques. Conduct research and stay updated on industry trends and developments. Provide technical support and guidance to junior team members. Job Requirements Strong knowledge of analytical techniques and methodologies. Excellent problem-solving and communication skills. Ability to work independently and as part of a team. Strong attention to detail and organizational skills. Experience with data analysis and interpretation. Familiarity with industry standards and regulations. Minimum of 4 years of experience in the field, preferably in an employment firm or recruitment services firm.
Posted 4 weeks ago
5.0 - 10.0 years
5 - 9 Lacs
Bharuch
Work from Office
R & D (Analytical Development) - Agrochemical Industry-Saykha,Gujarat. Industry Engineering Engineering Design R&D Quality Qualification Key Skills Green Field Projects UPLC R & D Analytical Development Chemical Research Chemical Chemical Analyst Analytical Chemical Analytics We are looking for a skilled professional with 5 to 11 years of experience to join our team as an R & D (Analytical Development) specialist. The ideal candidate will have a strong background in analytical development and excellent problem-solving skills. Roles and Responsibility Develop and implement new analytical methods and techniques to enhance laboratory efficiency. Collaborate with cross-functional teams to design and execute experiments and studies. Analyze data and results to identify trends and areas for improvement. Design and develop new instrumentation and equipment to support analytical activities. Provide technical guidance and support to junior staff members. Stay up-to-date with industry developments and advancements in analytical technologies. Job Requirements Strong knowledge of analytical techniques such as HPLC, GC, and Spectrophotometry. Experience with data analysis and interpretation software. Excellent problem-solving and communication skills. Ability to work independently and collaboratively as part of a team. Strong attention to detail and organizational skills. Familiarity with laboratory safety protocols and procedures.
Posted 4 weeks ago
5.0 - 10.0 years
5 - 8 Lacs
Gurugram
Work from Office
R & D (Analytical Development) - Agrochemical Industry-Saykha,Gujarat. Industry Pharma R&D Biotech Qualification M.Sc Key Skills R & D Analytical Development LAB Agrochemical UPLC Green Field Projects HPLC Chemical Research We are looking for a skilled professional with 5 to 11 years of experience to join our team as an R & D (Analytical Development) specialist. The ideal candidate will have a strong background in analytical development and a passion for driving innovation. Roles and Responsibility Develop and implement new analytical methods and techniques to drive business growth. Collaborate with cross-functional teams to design and execute experiments and studies. Analyze data and results to identify trends and areas for improvement. Design and develop new products and processes using analytical techniques. Conduct literature reviews and stay updated on industry developments. Provide technical support and guidance to junior team members. Job Requirements Strong understanding of analytical principles and techniques. Experience with experimental design and data analysis. Excellent problem-solving and communication skills. Ability to work independently and as part of a team. Strong attention to detail and organizational skills. Familiarity with industry standards and regulations.
Posted 4 weeks ago
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