Experience- 10 to 14 Years Qualification- M.Sc./ Ph. D Job description Responsibilities Develop novel non infringing robust processes based on QbD trials for APIs aiming to regulated markets (US, Canada, EU, Australia, Japan and Chinese) within budgeted cost and time. Circumvent patent claiming product and or process for API w.r.t. PSD, Polymorph, Impurity levels, Stability aspect etc. Drive innovation in synthetic methodologies and chemical processes. Lead the design, planning, and execution of synthetic chemistry projects. Guide synthetic chemists in synthetic process development of conventional and complex molecules. Supervise and mentor all lab team members in the group, defining and following-up on individual goals & objectives and development plans. Train and assist team member. Conduct performance reviews and support career development for team members. Analyze experimental data, interpret results, and draw conclusions to guide project direction. Prepare and review technical reports and project documentation (e.g. Design and development output, Process development report, etc.). Meeting and aligning the stakeholders towards meeting company goals. Assist Head-PR in the recruitment for vacancies by conducting technical interviews. Review and approve manufacturing site documents namely change control proposal, process validation protocol, process validation report, stability protocol, QRM amendment, Technology Transfer protocol, etc. in absence of Head-PR. Review and approve procurement related documents namely Suitability trial intimation, Suitability trial report, Provisional Vendor approval intimation, NVAI, etc. in absence of Head-PR. Review specifications and STPs. Review and approve documents namely change control management, deviation, etc. Collaborate with internal departments, such as manufacturing, quality control, and regulatory affairs to facilitate project progress and ensure alignment. Ensure safe lab environment and adherence of the group to EHS rules and programs. Desired Skills Experience in process research department in a reputed pharmaceutical organization. Experience in a regulated market is a must. Must be organized and detail oriented. Proficient in computer skills (MS Office, data analysis, Engg. softwares others) Good oral and written communication skills High sense of responsibility regarding scientific and professional activities. Ability to conduct diverse scientific projects in an organized and productive manner. Sound knowledge of basic synthetic chemistry Maintain good documentation of experiments in the lab. Ensure adequate and functioning equipment in all labs.
Job Title
Manager Process Research