44 Analytical Development Jobs - Page 2

Drug Discovery Process Development Formulation Science Analytical Development Synthetic Route Optimization Scale-Up Process Technology Transfer Regulatory Compliance (ICH, FDA, EMA, WHO-GMP) Good Laboratory Practices (GLP) Innovative Molecules Green Chemistry

Drug Discovery Process Development Formulation Science Analytical Development Synthetic Route Optimization Scale-Up Process Technology Transfer Regulatory Compliance (ICH, FDA, EMA, WHO-GMP) Good Laboratory Practices (GLP) Innovative Molecules Green Chemistry

We are looking Scientist ADL with leading pharma company in Thane. Experience required : 2-4 years of exp in Method Devleopment, Method Validation and Routine analysis in Injectble formulations. Instruments Handle: Balance, pH, KF, UV, IR, UPLC, HPLC (UV, PDA, ELSD, RI detectors), GC, Dissolution appratus (USP, IP) Method Development Report, Method Validation Protocol and Report preparation. SOP preparation. Inputs for STP, SPEC preparation. Co-ordination with CMO, Method Transfer at Plant Technical & Professional Knowledge required: Good technical knowledge of analytical techniques and instrumentation:Chromatography technique like High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC), Spectroscopy technique like UV-Vis and Infrared (IR), KF titration, zetasizer, Osmometer and Dissolution etc Skills in developing, optimizing, and validating analytical methods to ensure accuracy, precision, and reliability. Understanding of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Data integrity and relevant regulatory guidelines (e.g., ICH, FDA, EP) to ensure compliance. Strong analytical problem solving skills, good communication and teamplayer, organized person who meets project objectives and follow through with work assignments and drive completion of activities in timely manner Major KPI : Method Development, Optimization and Execution of Analytical Tests Work closely with lead scientists, project managers, and other departments (e.g., formulation, quality control, regulatory affairs) to support project goals. Analytical method tech transfer to CMO and execution. .Literature survey. Training and Skill Development

Role : Research Associate/ Sr. Research Associate - CMC (Analytical) Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Qualification : M. Pharma/M.Sc. in Pharmaceutical Analysis/ Pharmaceutical Chemistry from reputed University. Experience : Around 3 to 8 years of experience in analytical method development, method validation for formulations. Purpose of the Role : Work both as an individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Job Description : Carry out Analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements. Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines. Carry out & ensure Analytical deliverables for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements. Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements. Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements. Managing stability study related activities for assigned projects to achieve the objectives as per project requirements. Ensure external analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements. Carry out literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements. Review of ELN experiments, Data, Reports and documents generated within lab & those received from CRO/CMO in line with defined quality standards. Support procurement activities related to project & laboratory i.e. vendor contact, URS, SOW etc. in line with defined quality standards. Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard. Preferred Competencies in the role. Working experience with diverse dosage form and differentiated products preferred. Timely achievement of the project deliverables GDP/GLP compliance ensured for data, lab operations & processes. Sound scientific & communication skills Strong Leadership Skills Critical thinking, troubleshooting and problem-solving skills. Engagement & accountability towards the defined purpose Good team player

Day to day analytical activities for robust method development for peptide molecules by different techniques (HPLC and GC).Preparation of Analytical Developments Validation Protocol, process scale-up,validation of methods.Interact with customes. Required Candidate profile PhD Chemistry with 7+ years of experience in Analytical R&D in Peptide analytical method development, peptide characterization. Worked on Biotechnology, Chemical peptides and proteins related science.

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Reaction Monitoring and routine analysis Stability Analysis Preparation of Analytical report Handling all instruments wet analysis Method development & Method Validation

Job Title: LC-MS/MS Scientist Experience: 6-9 Yrs Location: Dholka Ahmedabad Department: CSBU-R&D - ADL Responsibility: Analytical Method Development by LC-Mass for all Project. Routine LC-Mass Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. Calibration of LC-Mass system. To maintain GLP in working environment. Regularly co-ordination with project scientist. Preparation of analytical data and submit to concern project scientist. Responsibilities: Routine LC-Mass Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. Developed New LC-Mass Method for all stages of new molecule as well as modified old method as per regulatory requirement. Protocol and Reports preparation. Calibration of LC-Mass as per SOP and maintenance of LC-Mass Systems. Trouble shooting during day-to-day analysis and discuss with R&D people of respective project. Maintaining record for all analytical reports by entering all the data in raw data note book and timely release of analytical reports. Preparation of MOA of LC-Mass analytical method. Provide training to the juniors. To maintain analytical data and reports Interested candidate can share there cv at shardulsinh.k@cadilapharma.com

Candidate should have hands on experience by analysis In-process and routine samples using Gas chromatograph, High performance liquid chromatograph, Ion chromatograph, and IR Candidate should have hands on experience in qualitative and quantitative analysis using GCMS, LCMS and HRMS Candidate should have adequate knowledge on Pharmacopeias and working standard and impurity standard qualifications. Candidate should have adequate knowledge on quality guidelines from ICH Candidate should have hands on experience in good documentation practices and communications skills by Vocal and writing.

Core Purpose of the Role: Analytical development supporting Formulation development Routine analysis of samples Method development Instrument calibrations Documentation Report preparation Miscellaneous lab responsibilities Role Accountabilities: Candidate should have very good educational and theoretical background. Candidate should have knowledge of calibration, method development and troubleshooting using various instruments like Zetasizer, Mastersizer, Osmometer, KF auto titrator, dissolution (I, II & IV), spectroscopic instruments e.g. UV spectrometer, IR and Chromatographic instruments e.g. HPLC/UPLC, GC, Liquid Particulate counter, etc. Knowledge of various regulatory guidelines w.r.t. method development, product development and documentation Knowledge of method development for injectable formulations w.r.t. tests like assay, degradation products, dissolutions, content uniformity, cleaning method, degradation products of liposomes/microspheres, free and bound API assay, etc. Knowledge of specification setting for parenteral dosage forms, in-process specifications as well as finished product specifications Knowledge and operating of instruments like LC-MS, GC-MS will be added advantage Education: M.Pharm / M.Sc Experience: More than 3 years up to 9 years

With the good command on analytical instruments (GC,HPLC , UV, etc.) and classical analysis. Knowledge of instrument calibration , new method development. Should be work as a team.

• Ensure compliance with Stage Gate and Design QA procedures. • Coordination between different stake holders – R&D, QC, QA, RA, Project Management for effective Stage Gate reviews and clearances of Stages. • Review PDRs, Scale up reports including Lab Note books • Participate in designing DOE trials in line with Process • Review Scale up protocols, Exhibit protocols, Process Validation protocols and reports • R&D IPQA • R&D procedural compliances – Qualifications, Calibrations, RLD Management, Stability Management • Responsible for deviation, investigation related to R&D. • Responsible for specification/STP review. Review and clearance of Analytical Method Validations • R&D Documentation Management -Issuance and retrieval • Responsible for clearing Formulation Projects for Scale up and Exhibit batches.

Good know of Digital, Microcontroller & Analog Circuits. Analytical skill for fault finding. Good expertise in handling multi-meters, CRO, Digital Oscilloscope, Function Generator etc. Electronics Production, Testing, Fault Finding & Development

Title: Group Lead - API Analytical Development Location: Bengaluru JD Plan and execute analytical activities of targeted projects and provide analytical support to complete project development within the timeline for DMF filing as per regulatory guidelines. Role Plan and organize daily analytical activities in co-ordination with R&D to appropriately develop analytical method by understanding the process and sample flow in order to complete project development within time Facilitate adhering to regulatory requirements & GLP requirements for DMF filing and lab compliance in case of external/internal audit Provide inputs to strategize the identified areas of innovation, check for feasibility and implement approved ideas so as to improve efficiency and maximise throughput of testing in the laboratories Co-ordinate with contract labs /manufacturing unit for method validation and method transfer so as to execute plant validation batches on time Characterise new standards of raw materials, impurities and API required for method validation and release Adopt Jaagruti recommendations for continuous improvement in day to day activities for enhancing performance and efficiency Educational qualifications: Post graduate in Chemistry or Pharmacy (M.Sc. / M. Pharm.) Relevant experience: 8- 10 years of experience in analytical method development in pharmaceutical industry. Capable of handling a group of about at least 6 members Conversant with new analytical technique, good management & Communication skills Very good time / man power management skills. Able to work with shorter deadlines and quick turnaround requests Able to multi-task on several projects simultaneously and work in fast-paced, team oriented environment

Greetings from Gland Pharma Limited!!! We are conducting Walk-In Interview for R&D Department - Injectables on Saturday (16/03/2024) at Gland Pharma Ltd, Gandimaisamma. Departments: FR&D Department / Analytical R&D - Injectables Designation: Trainee Chemist Experience: Freshers Qualification: M. Pharma/ B Pharma /M Sc (Analytical Chemistry) Job Location: Dundigal. Required Skills: For FR&D Department - Injectables 1. Planning & execution of formulation development activities within timelines. 2. Stability study protocol development and stability data evaluation. Evaluation of impurity profiles of drug substance and drug product. 3. Hands on experience with development of Injectable solutions, lyophilized drug products and other complex Injectables. For Analytical R&D Department - Injectables 1.Analytical method development, stability samples analysis and impurities identification by using instruments like HPLC, GC, LC-MS, and other analytical techniques. Date : 13-03-2025 (Thursday) Time : 08 : 30 AM to 10 : 30 PM Address : Gland Pharma Limited, SY. No: 143148/150&151, D.P.Pally, Near Gandimaisamma X Road, Quthbullapure, Hyderabad - 500043.

Key Responsibilities : Leverage in-depth knowledge of ICH, USP, EP, and IP guidelines to write and review developmental protocols and analytical reports. Participate in the ADL team, contributing to new method developments, method qualifications, and process development quality analysis for recombinant proteins and biosimilars. Conduct LC-based method development for quality evaluations, including techniques like RP-HPLC, Ion Exchange (IEX), and glycan analysis. Lead CE-based method development for quality assessments of recombinant proteins. Perform analytical tasks to support different stages of process development, from clone selection to upstream and downstream process optimizations. Undertake method qualifications and transfers, ensuring seamless transitions to manufacturing, quality control, or external laboratories. Plan and execute stability studies for R&D batches, assess stability trends, and provide insightful conclusions based on data analysis. Plan and manage experiments and day-to-day activities in the laboratory. Coordinate with external laboratories for outsourced analytical activities and ensure proper communication. Maintain detailed equipment logs, documentation, and ensure compliance with good laboratory practices (GLP). Compile and review experimental data, ensuring high-quality documentation. Qualifications and Experience : Masters degree in Biotechnology, Biochemistry, or Pharmaceutical Sciences, with a focus on biotechnology or related fields. 7-9 years of hands-on experience in analytical development for recombinant proteins (including mAbs and biosimilars). Strong knowledge and understanding of proteins, with expertise in LC-based analysis and method development. Experience working with ICH, USP, EP, and IP guidelines and protocols. In-depth knowledge of good laboratory practices (GLP). Strong team player with excellent written and verbal communication skills. Required Skills : Expertise in protein sample preparation techniques (centrifugation, concentration, extraction, etc.). Proficiency in the operation and troubleshooting of LC and CE systems. Experience with common laboratory instruments (e.g., UV-Vis Spectrometer, weighing balances). Strong analytical thinking and data evaluation skills, with a solid understanding of statistical methods. Proficiency in using MS Office tools for documentation and data analysis. Commitment to maintaining data integrity and adhering to good documentation practices. Key Competencies : Strong attention to detail and quality-focused mindset. Ability to collaborate effectively within cross-functional teams. Excellent organizational and time-management skills. Ability to independently plan and manage multiple experiments and tasks.

Role & responsibilities Job responsibilities comprise carrying out of Quality Assurance functions in day-to-day activities. JOB RESPONSIBILTY 1. Responsible for review, approvals and close outs of change controls, deviations, CAPA, incident reports and any other quality system documents 2. Develop, manage and improve Quality Systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities 3. Review and approvals of analytical and formulation development Master documents. 4. Review and approval of analytical activities protocols and reports 5. Submitting whole set of documents required for regulatory submissions for new products 6. Supporting for any regulatory queries from QA perspective 7. Review and approval of validation, qualifications protocols and reports, 8. Monitoring day to day activities in Analytical development and Formulation development in compliance to the GMP 9. Preparation, review and approval of SOPs 10. Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates 11. Control of documents includes documents storage, issuance, distribution, retrieval and destruction 12. Performing vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits 13. Conduct periodic audits of CMOs and Althera affiliate facilities. Participate in the vendor Qualification programme as and when needed. 14. Review and approve change control initiated at CMOs and co-ordination with European QA, RA aid customers and keep track till all the relevant activities are completed 15. Planning and conducting of self-inspection, preparing and sending self-inspection reports to concerned departments. Verifying the self-inspection compliance report for correctness and completion 16. Oversight and coordination with the Contract Manufacturing Organization (CMOs) on batches manufacturing activities as well Quality Management functions for Althera products 17. Coordination with the European QA team on supplying necessary QMS documents as required 18. Responsible for review, approvals and close outs of deviations, CAPA, OOS, OOT and incident reports raised by the CMOs. Timely review of effectiveness of CAP As. 19. Participate in investigations at the CMOs where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations. 20. Applying risk management tools wherever applicable in accordance with current regulatory requirements 21. Handling of Market complaints and to co-ordinate with respective CMOs to get the investigation done on timely manner with appropriate root causes and CAPAs identified. 22. Track all the QMS status of Althera products at CMOs are timely concluded, and reports are shared 23. Coordinate with CMOs in any Regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment. 24. Review and approve of CMOs validation and master documents (BMRs, BPRs, MFR, PVPs, PVRs etc) and Protocols (Validation, Qualification, cleaning, stability etc) 25. Oversee, support and coordinate with Althera affiliate manufacturing and Testing sites and the RnD site. 26. Preparation, Review of the PQRs for Althera products. 27. Ensure quality / technical agreements with contract manufacturing organizations (CMOs)are available and updated within timelines. Preferred candidate profile Perks and benefits best in the industry

Vacancy - Stability Team Lead/Manager - Investigational analysis in Analytical Department (formulation) Experience in years : 14 to 16 years in Regulated and Emerging markets Educational qualification : M.Sc Analytical chemistry Dosage forms : Oral solids, Liquid orals, Ophthalmic and injectable products Job description : 1) Will be responsible and accountable for the trouble shooting and investigational analysis of R&D stability samples 2) Sound technical and scientific knowledge for investigation of anomalies. 3) Root cause identification and CAPA for OOT and OOS for developmental stability samples 4) Online review of HPLC and UV raw data of stability 5) Well versed with operation of Empower 3.0 and Chromeleon 7.2 software 6) Has experience in handling a team of 4 to 5 members 7) Should have exposure to Assay, Dissolution, preservative content and related substances testing Candidates with prior experience in investigational and trouble shooting analysis is preferable.