Subhakanta Dhal
Senior Project Scientist
About
Interface on all project activities like licensing, pre-formulation studies, formulation development, stability studies, bio-equivalence study, manufacturing process, tech transfer, validation, buildup of regulatory dossier for submission, addressing regulatory queries and support for commercial launch.
Developed number of generic products which includes Para IV FTF filings for extended as well as immediate release dosage forms for US market.
Plan and organize day to day activities, micro planning, resources allocation and logistic support; Interface at various levels to establish strong working relationships with Regulatory, IP, Purchase, Process development, Pharmacokinetic and Supply Chain Department.
Expertise over development of Oral Liquid products (Oral solution, Suspension and Powder for suspension) for US and EU market.
Expertise over development of Waster coating, Granulation (Fluid Bed/Wet/Dry), Palletization by Extended release, and Bi-layered Tablets.
Good exposure to Osmotic Drug Delivery Systems (OROS) tablet Osmotic Systems; Also working on 505 (b)2 products with change in dosage forms and release characteristics.
Well-versed with current regulatory and QbD based development as per regulatory expectations. Excellent BE success rate.
Good hands-on experience on handling OOS, OOT, Incidences, and investigations at manufacturing plants; Have exposure of regulated markets like USA, EU, Canada, SA.
Motivate, develop, and train subordinates to reach the targeted level of performance and technical expertise.
Initiate and manage process improvement initiatives to reduce development timelines and improve the quality of submissions.
Strong team building skills to drive complex projects; mentoring team members on technical as well as other aspects for goal orientation and driving high performance.
Contact Information
Professional Email
****@****.com
Personal Email
****@****.com
Work Phone
(***) ***-***
Mobile
(***) ***-***
Local Location
Greater Hyderabad Area, India
Industry
Pharmaceuticals
Designation
Senior Project Scientist
Birthday
August 20
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