Pharmaceutical Analytical Chemistry: Open Access
Open Access

Kaushalendra Chaturvedi

Biography

PROFESSIONAL SUMMARY:

- Ph.D. in Pharmaceutics and Drug Design.
- Over nine years of experience in pharmaceutical field with 2.5 years of industrial experience in solid form screening,       crystallization, pre-formulation and formulation development.
- Solid knowledge of pre-formulation and materials science activities including form screening, salt/co-crystal screening,    crystallization process development, solid state characterization, and solid-state methods for dissolution and solubility improvement.
- Experienced in characterization of API/excipient/dosage form physico-chemical properties impacting drug release and in-vitro and in-vivo of drug product performance. Experienced in formulation development and processing technology.
- Demonstrated leadership in planning, executing, and completing research for publications (21 completed, 3 in progress). Strong record of publication, presentation and communication skills.
- Reviewer for publication house and international scientific communities including Elsevier, Springer, Royal Society of Chemistry, Tylor and Francis, American Association of Pharmaceutical Scientists, DOVE publications, Material Science Research India, and NERDG.
- Co-advisor/committee member in Ph.D. doctoral dissertation work for a Ph.D. candidate.
- Awarded by Rho-Chi Society and Who’s Who for extraordinary scholastic and leadership performance.
- Self-motivated, target-oriented, can work independently as well as collaborative, desired to work in flexible and dynamic environment.
- Ability to prioritize and schedule work to meet the demand.

SKILLS:

Materials Science and Product Development Skills: - Crystal form screening, salt screening and crystallization process development - Materials characterization of drug substances, excipients and finished drug products using Thermal Analysis, PXRD, SEM, Particle Size, Moisture Sorption, Thermal Microscopy, Reflection/Transmission Microscopy, and IR Spectroscopy.
- Developing and characterizing amorphous formulations using spray, freeze drying and thermal quench methods. - Relating materials’ physical properties and, their modification, to changes in melting point, solubility, glass forming ability and improved mechanical properties.
- Hands on using formulation equipment including but not limited to fluid bed processor, roller compactor, hi-coater, high shear mixer, hot melt extruder and single/multi-station rotary tablet press for formulating an oral solid dosage form from lab scale to manufacturing scale.
Molecular simulation and modeling:
Material Studio® expertise in studying crystal growth morphology, polymorph structures, molecular dynamics, adsorption studies relating molecular structure with physical properties and behavior.
Computer skills: Proficient in Material Studio (Biovia), Dynochem, Minitab 17, Microsoft Office, Empower, Chemstation, WinNonlin, and Simcyp.

WORK EXPERIENCE:

1. Senior Research Scientist
J-Star Research Inc, (A Member of the Porton Group)                                                                                      
- Successfully delivered 10 projects.
- Worked on more than 10 pharmaceutical molecules involving therapeutic areas such as anti-addiction, Relapsed/Refractory Acute Leukemias, Antineoplastic, Steatohepatitis, Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, Advanced Solid Tumor, Small Cell Lung Cancer, Colorectal Cancer, and Cardiovascular.
- Salt and co-crystal form screening of drug candidates including hydrates, solvates and polymorphs.
- Key member of a team responsible for setting-up formulation development laboratory designed to provide a support in solving the scientific problems associated with formulations and supplying finished dosage forms for pre-clinical and clinical studies.
- Evaluate crystal forms for acceptability as drug substances as it relates to chemical manufacturing and formulation into pharmaceutical products.
- Performing solid state physical and chemical characterization of molecules of pharmaceutical relevance including solid-state characterization using X-ray powder diffraction, thermal analysis, spectroscopy and particle morphology characterization.
- Solving scientific problems using contemporary solid state experimental and computational techniques.
- Actively involved in multidisciplinary project teams to define and implement screening and characterization strategies according to project timelines.

2. Senior Research Scientist
Lachman Institute for Pharmaceutical Analysis Laboratory, LIU                                                              
- Worked as a senior scientist on a US-FDA funded project entitled ‘Statistically Based Pharmaceutical Quality Standards’
- Worked on projects and other activities conducted under good manufacturing practices (GMP’s).
- Developed, and validated protocol for novel fiber optic dissolution system for pharmaceutical drug testing.
- Designed and developed first ever idea proposed of “New Prior Knowledge” in pharmaceutical industry with National Institute of Pharmaceutical Technology and Education (NIPTE).
- Worked on multiple research projects focusing on solid state changes of drugs and its impact on physical, chemical and pharmacological properties.
- Sample analysis/ material characterization of samples from pharmaceutical companies, contract research and manufacturing organizations (CRO’s & CMO’s) and compounding pharmacies.
- Writing and reviewing current and new standard operating procedures (SOPs) associated with instruments and laboratory practices.

3. Research Assistant
Natoli Institute for Industrial Pharmacy, Research and Development, LIU                                                      
- Worked with multi-national tablet tooling company “Natoli Engineering” on troubleshooting existing manufacturing process as well as development of new solid oral dosage forms.
- Conducted research in collaboration with multi-national companies on changes in the excipient functionality under different pharmaceutical manufacturing techniques.
- Worked in collaboration with pharmaceutical and excipient companies on pharmaceutical manufacturing process improvement.
- Trained industrial staff scientist and managers of pharmaceutical companies from USA, Canada, Mexico, and Latin America on different pharmaceutical unit operations including Granulation, Tableting, Fluidize Bed Drying, and Wurster Coating.
- Performed projects involving granulation, amorphous formulation development, hot melt extrusion, tablet coating and tableting.
- Conducted laboratory experiments and training sessions for PharmD students to trained them for North American Pharmacist Licensure Examination (NAPLEX).

4. Analytical Development-Intern
Ferring Pharmaceuticals Inc. New Jersey, USA May                                                                                         
- Assisted in designing and developing brand product for ulcerative colitis targeted delivery.
- Performed pre-formulation screening studies, designed and executed stability studies for microbead formulation.
- Surface characterization of beads inner and outer core using scanning electron microscopy (SEM), transmission and reflection microscopy.
- Characterization of drug in and coating on beads using thermal analysis i.e., DSC, TGA and DVS (Vapor sorption analyzer).
- Rheological characterization and stability of pectin solution used in formulations using Malvern Kinexus pro.
- Micro beads particle size analysis using Mastersizer 3000.

5. Scientific and Medical Writer
Crest Pre-media Solutions (A Springer Company), Pune, India                                                                   
- Reviewed and wrote updated clinical trials information and drug development programs information from the trial registry, clinical meetings, clinical conferences, publications from top medical journals and international conferences.
- Training new hires in tasks associated with the updating of existing clinical trial profiles and drug development profiles. Subject matter expert in clinical trial information writing and result writing.

6. Territory Manager
Medley Pharmaceuticals Pvt. Ltd, Mumbai, India                                                                                         
- Developed effective strategies for identifying new markets to launch the new product in the market.
- Handled a team to promote the product and making a new market base for the same product.

 

Research Interest

EDUCATION:

• Ph.D. in Pharmaceutical Sciences with specialization in Pharmaceutics, Long Island University, Brooklyn, NY, USA                                        
• Master of Science in Pharmaceutical Sciences with specialization in QAT, Pune University, Pune, India 
• Bachelor of Pharmacy, Pune University, Pune, India