206 Method Development Jobs - Page 9

Supervision of Sampling, Sample preparation, Sample Analysis, Instrument Calibration, Documentation etc.

We are hiring for a Public listed BSE / NSE - Pharma - API / Crop Protection / Animal Health Intermediates Mfg CDMO / CRAM Company. Role : Team Leader - ADL Title : Sr. Scientist R&D Centre Level : Deputy Manager CTC : Ceiling Rs 15 Lpa Experience: Minimum 14 years to Max 18 years Those working at R&D Centres of Crop Sciences / API / Specialty Chemicals are only eligible. Formulations / Vaccines / Bio labs are not eligible. Formulations Qualification : Full Time M.Sc in Organic Chemistry / Analytical Chemistry only. Those in other specialisation of Chemistry are not eligible. Those with Correspondence Masters degree won't qualify. Location: Pune Saturdays: 2nd / 4th Not working Local Company Transport on the major Trunk Road available. Those working in QC Labs not eligible. Those working in Foods Lab not eligible. Those working in Testing Laboratories should not apply. Role: To follow Good laboratory Practices. To follow the procedures mentioned in SOP's and General test Procedures To ensure availability of respective working standards/samples for method validation and method transfer activity To monitor periodic calibration of instruments as per the schedule To follow all safety standards while working To fulfil the requirement of RA department for different filings To review method validation data & preparation of respective protocol reports To ensure documentation of analytical activities as per Co. policy To provide complete support for internal & external Audits at Pune location To develop suitable analytical methods to support cross functional teams To prepare and review method validation protocols, data and reports

VACANCY FOR TEAM LEADER - ANALYTICAL METHOD DEVELOPMENT (FORMULATIONS) - REGULATED MARKET Experience: 10 to 15 years Designation : Asst. Manager/ManagerEducational qualification : M.Sc Job profile : Need to work independently and should have handled a team of 6 to 8 members for method development and routine testing To guide and mentor analysts with practical training for developing analytical methods. SOP training and Analyst certification for new joinees within the team. Work allocation and planning of daily activities for the team subordinates Monitoring of routine analysis and trouble shooting To support site for critical trouble shooting and investigation Review of raw data , LNB and filing of routine analysis SOP preparation and training Pharmacopoeia & DMF Review Interaction with cross functional teams Review of calibration data of analytical instruments Review and check file note/deviation with investigation and CAPA for the same.

Role & responsibilities Literature search using various search engines. Analytical Method Development of raw materials, active substances and Finished product. Analysis of raw materials, active substances and finished products. Preparation of test protocol. Experience in handling instruments like spectrophotometer, HPLC, and GC. Knowledge of analytical method validation. Knowledge of natural chemistry background and its analysis.

We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. Key Responsibilities: - Lead and manage chemical characterization studies, including planning, execution, and reporting of results. - Develop study protocols and ensure compliance with regulatory guidelines and internal standards. - Coordinate and communicate with cross-functional teams. - Analyze and interpret data, preparing comprehensive reports and presentations for internal and external stakeholders. - Mentor and train junior staff in scientific techniques and best practices. - Ensure that laboratory safety protocols are followed and maintain a clean and organized work environment. - Stay current with industry trends and advancements in chemical characterization methodologies. Qualifications: - Ph.D. or equivalent degree in Chemistry, or a related field. - A minimum of 10 years of experience in chemical characterization or a similar role within a laboratory setting. - Expertise in techniques such as LCMS - QTOF, GCMS, NVR, ICPMS, IC and other relevant analytical methods. - Strong project management skills with the ability to lead multiple projects simultaneously. - Excellent communication, organizational, and problem-solving abilities. - Familiarity with regulatory requirements and guidelines in the pharmaceutical or biotechnology industry. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation to completion, ensuring adherence to regulatory standards and internal protocols. 2. Design study plans and methodologies that are scientifically sound and aligned with project objectives, including the selection of appropriate analytical techniques and equipment. 3. Coordinate with cross-functional teams, including project managers, chemists, and quality assurance personnel, to ensure effective study execution and communication. 4. Review and approve study protocols, analytical methods, and reports to ensure accuracy, compliance, and scientific integrity. 5. Provide technical expertise and guidance related to chemical characterization, including the interpretation of analytical data and results. 6. Ensure that all studies are conducted in compliance with Good Laboratory Practice (GLP) and other relevant regulations. 7. Manage study budgets and timelines, identifying potential risks and implementing mitigation strategies to ensure successful project delivery. 8. Train and mentor staff on appropriate methodologies and regulatory requirements related to chemical characterization studies. 9. Participate in project meetings, presenting study findings and progress updates to stakeholders, and incorporating feedback into study design and implementation. 10. Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting chemical characterization and related fields. 11. Facilitate communication with regulatory agencies as needed, providing data and documentation to support submissions and inquiries. 12. Contribute to the continuous improvement of departmental processes and methodologies, ensuring best practices are followed in study design and execution.

Roles & Responsibility: Perform method development, method validation and study sample analysis under supervision of Project Manager (s). Passaging of cells as well as performing cell based assays while maintaining aseptic conditions in cell culture laboratory. Perform ELISA & other Ligand Binding Assay according to study protocol guidelines and/or SOPs Processing of specimens to support the clinical studies. Preparation of required reagents and solvents. Preparation of SOP(s) and work instruction. Following GLP, GDP, GCLP & other good practices. Desirable candidate: MSc BioTech/ Biochemistry/ Microbiology or BTech Biotech fresher. 0-1 year of relevant experience will be preferable. Sound knowledge on Immunology. Good communication skills, analytical skills and team coordination.