Highly motivated ‘Formulation Scientist' with product development skills on liquids and semi- solid dosage forms. 4 Years of experience working with new molecules and generic product development including scale up, technical operations, transfer/commercialization and manufacturing.
• New Product development
• Worked on process development, manufacturing activities consistent with overall project timelines and quality for various dosage forms like Semi-Solids (Suppositories and different ointments, creams and Topical solutions).
• Experienced working on different category drugs like Hormonal, Retinoids and corticosteroids.
• Developed formulations and technologies for both ANDA'S and NCE's and NCE-1 drugs from pre-formulation studies to scale up and successfully achieve Q1/Q2/Q3 parameters.
• Worked on developing different reports/protocols like DEC studies, stability protocols, solubility studies and PDR reports.
• Applied Design of Experiments (DoE) using JMP software to attain QTPP (Quality Target Product Profile) by identifying CPP's and CMA's.
• Hands on experience with different instruments like Malvern rheometer, Brookfield Viscometer, Microscope (AxioCam MRc 5) and R&D under vacuumed axomix-5L and 10L.
• Supported GLP/GMP manufacturing, including provision of process instructions, batch record review and hands on source.
• Familiar with CMC-related activities, including formulation development and container closure system evaluation, filling and packaging.
• Peer review of laboratory notebooks and batch records.
• Experienced working on Liquids and semi-solid dosage forms (creams, ointments, gels).
• Planned and performed laboratory experiments to develop and optimize formulations and manufacturing processes, under cGMP/GLP/GDP environment for ANDA Submissions.
• Conducted Pre-Formulation Studies to understand physical-chemical properties of compounds and perform related patent and literature search.
• Conducted Excipient- compatibility and Solubility Studies as a part of Pre- formulation.
• Scientific documentation of lab experiments, data analysis and technical reports writing.
• Assisted in developing the Product Development Reports (PDR), Stability protocols and batch Manufacturing Records (BMR) for exhibit and Scale up Batches.
• Co-ordinated with the analytical development and reverse engineering departments to prepare the products for Bio-equivalence studies.
• Conducted Microscopic evaluation and viscosity for semi- solid dosage and assist in Invitro Release Testing (IVRT) Studies.
• Hands on experience with Stirrers, mixers and Jacketed Kettles, Rheometer (TA Instruments), Brookfield Viscometer.
• Provided note-taking support for disabled students in lectures, seminars, and classrooms.
• Liaison between student, professor, and Disabilities Dept.
• Kept the department informed of any changes.
• Actively Participated in Patient Counseling Activity.
• Analyzed and understood the illness of the patient and their medical history
• Educated the patients about their medication's interaction with food and other drugs, dosing intervals and possible side effects.
Have generic product approvals for Cyproheptadine Hydrochloride syrup 2mg/5 mL( Antihistamine) and Albuterol Sulfate Oral syrup, 2mg/5mL (Bronchodilator).
Have OTC product approval for Children's Cetirizine Hydrochloride Solution, 5mg/5mL (Antihistamine)
Developed Non- Steroidal Ointment for treatment of Psoriasis and visible plaque which is going to the Phase III clinical
Developed Topical solution for treatment of Moderate to Severe case of Atopic Dermatitis which is in Pre-Clinical stage.
• Developed a Formulation and had a patent and paper titled "A Factorial Study on Enhancement of Solubility and Dissolution Rate of BCS CLASS 2 Drug RITANOVIR BY Using Solutol HS-15 and HPβcd" in IJCSR.
• Completed review paper on ‘Significance of Various Chromatography Techniques in Drug discovery and Development".
• Presented a poster at 64th IPC (Indian Pharmaceutical Congress) held at Chennai, India, during the year 2012.
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