Darshana Kamble
About Candidate
A result-oriented skill in local and International Pharmaceutical Contrivance Industry standards complimented by a M. TECH. (Pharmaceutical Science and Technology) Educational background and 2.5+ years Professional experienced and responsible in Pharmaceutical Projects as Formulation and Development (F&D) Officer.
1)Lead key new developed product projects with R&D to support business goals.
2)Understand customer expectations on to-be new developed product.
Participate with procurement and finance team to select materials (excipients / medicinal ingredients) which meet financial goals and contribute to cost saving initiatives. I recommend ingredients / processes which will improve manufacturing efficiencies.
3)Develop/review Raw Material and Finished Product Specifications, in collaboration with Product Development Manager and Quality Assurance/ Quality Control Department.
4)Research design & evaluate materials, assemblies, processes & equipment before taking any types of products.
5)Conduct experimental testing and evaluation of raw materials, dry blends and bulk product.
6)Coordinating formulation and analytical resources as needed, including those provided by production/manufacturing, quality control, quality assurance, supply, regulatory affairs.
7)Preparation of manufacturing trial documentation for pilot / small production runs & scale-up operations as per guide line.
8)Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production runs in collaboration with the R&D technician.
9)Research and compile raw material documentation for pre-formulation assessment to ensure compliance to testing specifications and regulatory requirements, for new products and existing products whereby and new material is sourced contributed
10)Attend the investigations into product failure including quality, potency, visual characteristics and other.
11)Contribute Involvement in all trouble-shooting activities.
Initiate stability testing (accelerated/on-going) of new products and review/report results in collaboration with Product Development Manager and Quality Assurance/ Quality Control Dept.
12)Monitoring team metrics and objectives ensuring meeting of goals.
13)Knowledge of Comply with GMP’s, SOP’s and all regulatory documentation.
ACHIEVEMENT
1)Article in Indian Express CPHI &P-MEC INDIA 2019 SPECIAL: Darshana Kamble, Dr. Namita Varde and Aditya Marfatia; “Transition from manual to automated dissolution sampling: Impact of rinsing “Express Pharma (Vol.15, No.2) page no. 99-100; November 2019.
2)Bioorganic and Medical Chemistry Letters 40 (2021)127916- “One pot synthesis, in silico study and evaluation of some novel flavonoids as potent topoisomerase II inhibitors”.
