To lead a team of 5-8 members of the team to develop phase/scope appropriate robust Analytical methods using complimenting analytical techniques, for early phase to late-phase NCEs, taking end to end ownership of analytical project deliverables, to ensure delivery with high OTIF.
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 CFT's
- 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/ M Pharm (12-15 years) or PhD (8-12 years) in Analytical Chemistry from reputed university
