Responsible for contributions to the scale up of APIs under non-GMP and cGMP manufacturing in the Process Chemistry Kilo Lab (PCKL). This position requires responsibility of delivery of all required drug substance, of appropriate quality, to support development programs for pre-clinical studies including IND for Phase I up to Phase IIa clinical studies. Overall responsibilities for the smooth and safe operations, and maintenances of the process development laboratories in TCG GreenChem. Operate under cGMP guidelines in a highly compliant environment. Responsible for establishing SOPâ€™s, safety and compliance guidelines for process chemistry. Introduce new and state of the art technologies and equipment to the kilo lab and tech transfer to the pilot plant.
- Provide required amount of drug substances of appropriate quality for clinical and non-clinical studies by maintaining safe and compliant operation of PCKL at all times.
- Provide leadership to multiple departmental sections, stressing the competencies of analytical thinking, communication, continuous improvement/learning, teamwork, and business and technical competence.
- Lead, mentor and develop employees in technology transfer from the lab to the Kilo lab, including fostering a culture of collaboration.
- Participate in efforts in developing chemistries to run smoothly in the Kilo lab and contribute to process knowledge while mentoring others in the process.
- Embracing and exhibiting a sense of urgency in creating, developing, maintaining and utilizing Kilo Lab to its full capacity/potential with a constant eye in improvement of processes, embracing and implementing technology.
- Embracing and emulating a positive attitude among other employees, for the company and be a role model for others and for the company.
- Ensure safe and smooth operation of Kilo lab understanding engineering equipment, GMP, quality and computer operations in chemical scale up environment.
- Complies with established SOPs and procedures and appropriate cGMP regulations, training, safety, personnel policies, intellectual property, and corporate policies.
- Masters degree with 15 years of industry experience or Ph.D. degree with 7 years of process development, tech transfer to kilo lab and/or pilot plant experience.
- Requires the ability to communicate effectively: Requires the ability to prepare technical reports, and oral presentations. Requires the ability to communicate results both internally and externally. Excellent track records of delivering results on complex projects.
- Requires the ability to lead and participate in interdisciplinary and/or international teams.
- Requires the ability to manage all aspects of complex operation such as transfer of process from bench scale to Kilo-lab and to Pilot plant, etc.
- Requires thorough understanding of cGMP, FDA, EPA, OSHA, Drug Regulatory Affairs requirements, and ICH guidelines, etc.
- Excellent verbal and written communication
- Critical thinking
- Problem solving
- Active listening
- Out-of-the-box thinking
- Knowledge of regulatory requirements
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