ANUSHA BAPATLA

Richmond, VA ***** 973-***-**** adkj3h@r.postjobfree.com

PROFESSIONAL SUMMARY

Highly motivated ‘Formulation Scientist' with product development skills on liquids and semi- solid dosage forms. 5 Years of experience working with new molecules and generic product development including scale up, technical operations, transfer/commercialization, and manufacturing. SKILLS

• New Product development

• Generic Product development

• R&D and Scale up production equipment.

• Raw material evaluation

• Tech transfer/ commercialization

• Hands on experience on Rheometer, DoE, QbD

(Quality by design)

• Container Closure Systems

• Quality, cGMP, FDA, ICH regulations.

• Microsoft word, Excel, Power Point

WORK HISTORY

Sr. Product Development Scientist - Topical Dosage Forms, 12/2020 to Current GSK Consumer Healthcare – Richmond, United States

• Contributed to multiple projects in support of Brand Innovation strategy.

• Ensured all work is conducted in accordance with written procedures (e.g. quality and safety), methods & batch documents, etc.

• Contributed to departmental quality documentation (including SOP’s, batch documentation, validation protocols & reports).

• Specified safety and quality responsibilities for department and site (e.g. GMP, Audits, Health & Safety).

• Delivered all EHS standards and expectations on site and within the laboratories for different scale up equipment like Axomix, Esco Labor and Ross mixers.

• Participated in consumer engagement research to understand the category and needs.

• Collaborated with Consumer Understanding and Sensory scientists and contributed to the development of consumer-driven innovation.

• Maintained awareness of scientific literature to assist work progression and understanding. Formulation Scientist-II Topical Dosage Forms, 03/2017 to 28/10/2020 Tergus Pharma, Inc, – Durham, United States

• 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. Formulation Scientist –I Liquids & Semi-solids, 03/2016 to 03/2017 Quagen Pharmaceuticals, LLC – West Caldwell, NJ

• 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.

Note Taker (Student with Disabilities Department), 01/2015 to 05/2015 Fairleigh Dickinson University – Madison, NJ

• 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.

Patient Counselor, 10/2011 to 11/2011

Andhra University Dispensary – Visakhapatnam, Andhrapradesh

• 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.

EDUCATION

Master of Science: Pharmaceutical Chemistry, 05/2016 Fairleigh Dickinson University - Madison, NJ

• Graduated in Master of Science in Chemistry with concentration in Pharmaceutical Chemistry.

• Graduated with GPA of 3.2, Course work included Biochemistry, Chemical Kinetics, Instrumental Analysis, Pharmaceutical Analysis, Pharmacokinetics, Pharmacology, Physical Organic Chemistry.

• Gained experience working on instruments like HPLC (Agilent) and FTIR, UV-Spectrometer, Wet chemistry techniques.

Bachelor of Science: Bachelor of Pharmacy, 05/2013 Andhra University - Andhra Pradesh

• Studied Bachelor of Pharmacy with understanding on dispensing medication, advising patients about general health topics such as diet, exercise, and managing stress as well as other issues.

• Graduated with a GPA of 3.5.

• Core courses included Pharmaceutics, Regulatory affairs, Industrial Pharmacy, Analysis. ACCOMPLISHMENTS

Generics/ OTC

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) New Molecules

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.

ADDITIONAL INFORMATION

RESEARCH EXPERIENCE

• 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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