Experienced in analytical testing of Drug substances, Drug products and Stability products. Experience in supervising and mentoring lower level QC Chemists. Experience in performing analytical inspection of raw materials, packaging components, In-Process samples, Finished Products,Stability samples, Drug Intermediates, Process Validation and Cleaning Verification samples. Experience working in a R&D and/ or QC laboratory following cGMP, FDA and OSHA standards. Experience working in DEA regulated environment. Capable of working independently and in a team, possessing excellent interpersonal and communication skills. A team player who can work closely with other members of the group and considerate of team member's input. Skilled in reviewing and writing technical papers, maintaining lab notebook and documentation, analyzing data efficiently and reporting to the lab management on a daily basis. Self-Starter, adept and competent at starting projects on own initiative; can work efficiently and effectively in an environment with a common sense approach on dealing with issue.
Highlights
Waters & Shimadzu HPLC, UV-VIS, FTIR, Instron, DSC, GC with FID, TLC techniques, Dissolutions (USP Apparatus I and USP Apparatus II), Disintegration, Friability, X-ray, TGA, DTA, Titrations, KF titrator and pH Meter.
Software's: Empower 3, Bluehill, Perkin Elmer UV Winlab, ChemStation, Class VP, Dasylab 9.0, Varian resolution pro, Omnic, STARe software, MS Office Applications (MS Word, MS Excel and MS PowerPoint), ChemDraw.
Accomplishments
Experience
QC Chemist II, 04/2015 - Current Apex Systems – Franklin, TN,
Conduct all types of QC Chemical testing.
Experience in performing analytical inspection of raw materials, packaging components, In-Process samples, Finished Products, Stability samples, Drug Intermediates, Process Validation and Cleaning Verification samples.
Supervising and mentoring lower level QC Chemists as appropriate.
Help QC Management analyze the sample inspection and testing status.
Support Manufacturing, Technical Services and Product development departments for product inspection as required.
Ensure work environment is clean and safe complying with safety and pharmaceutical regulation.
Follow established Standard Operating Procedures and methods.
Adept, maintain and operate analytical instrumentation.
Operation, maintenance and calibration of basic laboratory instruments as scheduled.
Documenting and reporting the results adhering to Good Documentation Practice.
Train other Chemists on analytical methods as required.
Adhere to all applicable procedures, cGMP's, company policies and any other quality or regulatory requirements.
Support Product Development Laboratories to ensure compliance with company's policies and procedures along with GLP and OSHA and GMP requirements.
Perform physical characterization of prototype raw materials, including mechanical testing, analysis of thermal behavior etc.
Characterization of in-process Regenerative Technology products using DSC, HPLC, FTIR, UV-VIS, Shrink temperature.
Performed assay (Free & Total formaldehyde content, Enzyme degradation assay), content uniformity, purity check (HPLC) and sample tests of ingredients.
Perform qualitative and quantitative chemical analysis of prototype materials including assay for chemical components, enzymatic degradation, spectroscopy etc.
Troubleshoot technical issues encountered during physical and chemical characterization.
Reviewing technical papers, SOP's and reports as per requirement.
Assist Manager of Analytical Services to maintain Analytical Laboratory in accordance with OSHA standards.
Assisting in Validation of test methods and method transfers of products.
Supporting Quality Control Facility in characterizing In-process and Finished Regenerative Technology products.
Performing duties equivalent to Quality Control Chemist.
Write OOS investigation reports as per requirement.
Supporting the management in all other duties whenever required.
Research Assistant, 01/2015 - 12/2015 Loyola University Of Chicago Inc – Chicago, IL,
Work involved synthesis and characterization of Nano Manganese dioxide.
Developed strong laboratory writing skills and also gained experience in reviewing & writing technical papers.
Developed synthetic methods to improve the nano size of the synthesized metal oxides.
Investigated the thermal behavior of the metal oxide using TGA (Thermal Gravimetric Analysis) & DTA (Differential Thermal Analysis).
Solid state characterization of materials.
Carried out structural studies using XRD (X-ray Diffraction) and FTIR.
Studied the effect of polymer type on morphology of synthesized Nano metal oxide.
Academic Reinforcement center, Tutor, 10/2015 - 12/2015 Kansas State University Foundation – Manhattan, KS,
Helping student in problem solving.
Assist the students and conduct tutorials in Organic chemistry, Biochemistry, Physical Chemistry and General chemistry.
Be available to students through consultation hours and pit-stop tutorials as and when required by the director.
Teaching Assistant, 09/2015 - 12/2015 Long Island University – City, STATE,
To assist the students and Professors in handling of experiments and in practice of GLP.
To conduct lab classes in organic chemistry, biochemistry, physical chemistry, wet chemistry and general chemistry as required.
Updating up to date reports to Head of the Lab.
Updating Health and Safety knowledge by attending regular refresher courses.
Attending weekly CONNECT communication program to update.
Mark assignments, exams and other student activities.
Work History
, - Dept. of Chemistry & Biochemistry – ,
, - Department of Chemistry & Biochemistry – ,
Education
Master of Science: Chemistry, Expected in January 12 - Long Island University - , NY GPA: Chemistry
B.Pharmacy: , Expected in May 09 - Kakatiya University - , Andhra Pradesh GPA:
MBA: Health Care Management, Expected in - Goldey Beacom College - , DE GPA: Health Care Management
Interests
PHARMA FLAIR 2008, Balaji Institute of Pharmaceutical Sciences, Warangal, India, participated in national level paper presentation, "Nanotechnology and Nano-Medicine" and awarded first prize.
*CMR College of Pharmacy, Hyderabad, India. Participated in National level seminar, "Nanotechnology".
*PHARMA VISION 2020, Indian Pharmaceutical Congress at Delhi, India. Participated in National level paper presentation, "Clinical Case Study of Patients with Pulmonary Tuberculosis and Diabetes Mellitus".
Additional Information
Presentations & Awards:
*PHARMA FLAIR 2008, Balaji Institute of Pharmaceutical Sciences, Warangal, India, participated in national level paper presentation, "Nanotechnology and Nano-Medicine" and awarded first prize.
*CMR College of Pharmacy, Hyderabad, India. Participated in National level seminar, "Nanotechnology".
*PHARMA VISION 2020, Indian Pharmaceutical Congress at Delhi, India. Participated in National level paper presentation, "Clinical Case Study of Patients with Pulmonary Tuberculosis and Diabetes Mellitus".
Skills
basic, Biochemistry, calibration, Chemistry, Chemist, consultation, content, Documentation, DSC, experiments, FTIR, GC, GMP, GLP, HPLC, inspection, director, Mark, materials, mechanical, mentoring, MS Excel, MS Office Applications, MS PowerPoint, MS Word, packaging, Perkin Elmer, policies, problem solving, Product Development, quality, Quality Control, reporting, requirement, Safety, SOP, Supervising, Troubleshoot, type, UV, Validation, writing skills, X-ray
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