Lead departmental compliance with Safety Health and Environmental (SHE) rules/regulations by training, adhering and monitoring as well as reporting any work place incidents, injuries and accidents immediately
Lead R&D team(s) in the Process Research and Development of Early Stage/Late Stage Route selection and Scale up of NCEs/Drug Candidate/API (Active Pharmaceutical Ingredient) programs
Act as a leader in resolution of technical and scientific challenges of multiple and inter-dependent programs
Possess good knowledge of Route Scouting (Alternate/Non-Infringing RoS), Evaluation, Identification, PoC, Process Research and Development, Technology transfer from Lab scale to Kilo lab, Pilot plant scale and finally to Plant for Commercial production
Develop process research project plans in coordination with other allied departments such as Analytical Services, Operations, Scale up, GMP and Quality Assurance.
Possess good knowledge in QbD/DoE tools & techniques for process research
Possess skills in interpretation of NMR, MS, IR, GC, HPLC, Solid State properties (XRD, DSC, TGA, PSD etc.)
Monitor project progress through tools such as regular status meetings, scheduled reviews, scientific presentations, Gantt Charts etc.
Actively contribute to project success through the technical review of lab and scale up efforts as well as regular budget review activities
Engage routinely with Technology Transfer, Scale up and GMP Manufacturing teams for a constructive collaboration towards efficient and successful scale up and GMP manufacturing
Fulfil a key point of contact role for clients on scientific and technical matters related to projects
Manage and review Weekly/Bi-Weekly updates for clients, Campaign reports, Process Development Report/TTD to transfer technology to pilot plant and Final project reports
Lead and/or contribute to departmental initiatives or responsibilities as assigned by Director, PRD and Scale up
Support and develop business opportunities from RfPs/RfQs working closely with Business Development team.
Person Profile
Qualification: -
M.Sc/Ph.D/Post-Doc in Organic Chemistry
Experience: -
10-15 years industrial experience in Process Research and Development of NCEs/Drug Candidates/APIs in CRDMO/CRAMS
