Principal Scientist will manage the successful development, implementation and evaluation of complex, small molecule process chemistry research projects in a timely manner as well as contribute towards effective departmental operations.
Duties and Responsibilities:
- 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
Qualification:
- Educational qualifications: M.Sc/Ph.D/Post-Doc in Organic Chemistry
- Experience: Minimum 10-15 years industrial experience in Process Research and Development of NCEs/Drug Candidates/APIs in CRDMO/CRAMS
- Soft skills and attributes: Strong written/oral communication, strong interpersonal skills, proven experience in managing teams of size of 10 to 15 Chemists/Scientists.
- Proven experience in managing NCE/API programs in CRDMO/CRAMS
