15+ years of experience in Manufacturing, GMP, Safety, resolving technical customer queries.
Responsibilities for Internal Candidate
Hands-on experience in advanced working knowledge of science relating to production of APIs and intermediates. Specifically, practical organic and analytical chemistry to understand reaction mechanisms, side-products, and by-products to overcome quality, safety, and productivity challenges.
Experienced in trouble-shooting, with credible case studies of overcoming manufacturing challenges before and during production campaigns and providing CAPA
Managing and coaching team members, keeping delegation in mind and developing a strong trouble-shooting team on the job.
Responsible for chemical process improvement and cost reduction of commercial projects.
Responsible for design the scheme of experiments for given target with scalable, safe, environment friendly and cost-effective process.
Responsible for plant simulation, scale-up/ technology transfer to manufacturing scale
Responsible for technology accommodation, DOE, demonstration, and active participation in successful technology transfer as well as running projects.
Guide in carrying experiments during the feasibility and optimization stage.
Visualize the development needs of the product in advance.
Guiding in preparation of RFP and coordinate with all CFT.
Understand the safety and environmental aspect.
Solve the problems and queries related to the development of the product.
Identify all critical process parameters for a seamless scale-up.
Guide in carrying IUT, VQ, TL, LFR/PDR reports documentation individually/review.
Understand the scalability of the chosen process, in coordination with TSD and Production.
Keep the HOD well informed about the experiments and the results by maintaining the lab journal/ documents as well as per GMP requirements.
Document all the relevant data in systematic manner and regularly discuss with HOD for way forward.
Good knowledge on literature search resulting on best ROS and process.
Mentor, empower and guide the scientists and junior chemists in the lab on process development, GMP and good communication.
Keep the work area clean, safe and the laboratory auditable all the time.
Responsible for department related administrative activities identified by self and HOD from time to time.
Flexible for planning, work on project requirement and shifts to address the requirement.
Voluntarily involve in additional responsibilities., Safety, ESI, and corporate social responsible programs based on requirement.
Handle teleconference internally and with Client timely/regularly and effectively.
Suggesting for facility upgradation based on business potential and commercial success.
Organize documents, chemicals, glass ware and lab instruments for easy access and functional.