02 Aug
|
Sai Life Sciences
|
India
02 Aug
Sai Life Sciences
India
Key Responsibilities
Responsible for understanding the project scope, as well as scope changes.
Regularly review of the progress of the project and ensures that the teams operate within project scope to deliver the scientific and delivery milestones with expected high QUOTIF.
Handling, Maintenance and Calibration of HPLC &UPLC; (UV, CAD and ELSD) Instruments (Agilent , Waters ,Shimadzu) with experience API process development support or CDMO.
HPLC support for raw materials, In-process, Intermediates, Finished Products in API and CDMO
Expertise in HPLC method development and method qualifications.
Reviews the data presented by team and technically guides them further / suggest course correction, wherever required.
Collaborates and resolves issues with CFTs
Review of ELN data and Calibration data.
Complete Analysis and Routine analysis support for APIs, Intermediates and Raw materials.
Perform the Working Standard and Impurity Standard Qualifications
Preparation of spec & STPs, reference standard COAs, ATRs.
Responsible for weekly updates to customers and handling the telecoms.
Ensures that appropriate and meaningful data generated during the development phase.
Technical knowledge of other analytical technologies like GC, wet lab techniques, LC-M , NMR etc.
Responsible for timely completion and review of method development / analytical technical reports and weekly updates.
Responsible for productivity, timely closure of investigation reports, safety compliance, GLP compliance (wherever applicable) and 100 % data integrity, calibration of equipment’s and maintenance of infrastructure of his lab / project.
Qualification M. Sc/ MPharm Or Ph.D. in Analytical Chemistry from reputed university.
Experience:
M.Sc./M Pharm. with 12 to 15 years and Ph.D. with 8 to 12 years of experience with Analytical Development supporting preferably NCE development / CDMO/ API process development. Must have handled the team of at least 4 members.
📌 Team Lead Analytical R&d Api Telangana (India)
🏢 Sai Life Sciences
📍 India