Manager Process Research

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.