Manufacturing Medical Device
Resume:
Nikita Patel
ac5vxw@r.postjobfree.com
*** **** **, *** **** CA 95123
Seeking Regulatory/QA position in Pharmaceutical/Medical Device industry where my expertise in Pharmaceutical / Biotechnology will be utilized.
Summary:
Strong regulatory background with Master of Pharmacy (Regulatory/QA) and more than 4 years experience in biotech/pharmaceutical industry
Familiar with safety and regulatory requirements
Experience with method development and validation
Assist management in preparation of internal customer and agency audits
Standards:
GMP, GLP, GCP, US-FDA, CFR21, ISO, WHO, IND, NDA, ANDA, CDER, DMF, eCTD, ICH, CAPA, IP, USP, EP
Skills:
Analytical: HPLC, GC, LC/MS, GC/MS, FTIR, KF, UV spectrophotometer, ICP-OES, ICP/MS
Bio-Analytical: SDS-PAGE, Western blot, Gel Electrophoresis, DNA/RNA extraction, Transfection, PCR
Software: Unicorn, Chemstation, Softmax, Chemdraw, Salesforce.
Academic Qualifications:
Masters of Pharmacy (QA/Regulatory) Ganpat University, Gujarat (2012)
Bachelors of Pharmacy, C.K Pithawalla Institute, Gujarat (2010)
Regulatory affair (RAC) (April 2019)
Work Experience:
Research Associate, Aragen Bioscience (Contract Research Organization) (June’16 – present)
Operated under GLP
Expertise in Protein Purification (Antibody/antigen/fusion protein) on large scale using AKTA system and small scale - MabSelect, Protein G, Ni-Excell columns
Protein formulation - Dialysis and concentration
Determined the titers for Pilot protein purification by ForteBio, ELISA and drip purification
Analytical protein characterization methods, including SDS-PAGE, SEC, Western blot, ELISA; endotoxin measurements-LAL test, gDNA assay, PCR
Prepare report, maintain records in lab notebook, document SOP
Maintained Batch-records for buffer-preparation and protein purification
Staff Research Associate, Aromyx (Mar’15 – May’16)
Responsible for membrane preparation and protein analysis using Bradford assay, UV-visible detection
Preformed SDS-PAGE, western blot and ELISA for protein expression
Developed cAMP assay for GPCR
Maintain cell line and prepare new constructs for expression of protein in yeast.
Responsible for preparation of culture media, reagent and buffer
Authoring SOPs, revising and updating them as per USP requirements.
Training technicians on using equipment’s and performing tests.
QC/QA Chemist, Shree Additive Pharma & Food, May ’2012 – May’2013
Ensure laboratory compliance with federal laws and regulatory guidelines like FDA, GMP
Performing IQ, OQ and PQ of instruments to make it operational under GMP regulations.
Performed chemical and physical test on drug products
Responsible for HPLC methods development for new products
Extensively used HPLC and UV-visible instruments during HPLC method development
Responsible for data collection, calculation, analysis report and Maintain SOP
Utilize, maintain and troubleshoot equipment’s at regular interval.
M.Pharm Project: (2011-2012)
Develop and validate Different analytical methods as per ICH guidelines
Performed stability study by HPLC
Performing analytical chemistry assays based on new and existing methodologies as per different regulatory guidelines
Manufacturing Chemist Intern, Bombay Tablet, Apr’2010 – Aug’2010
Supervised manufacturing activity of capsule, tablet and syrup.
Responsible to verify GMP standards during drug production.
Created manufacturing and packaging batch records.
Training:
EHS/OSHA safety Training.
GMP/GLP/Manufacturing Batch Record
Publications:
First derivative spectrophotometric method for simultaneous estimation of ciprofloxacin and metronidazole in their combined dosage form. In International Journal of Union Pharmacy and Life Science. (IJUPLS) ISSN NO. 2249-6793.
Q-Absorbance Ratio Spectrophotometric Method for the Simultaneous Estimation of Ciprofloxacin and Metronidazole in their Combined Dosage Form. (JPSBR) ISSN NO. 2271-3681
Ciprofloxacin and Metronidazole in Lambert Academic Publishing. ISBN NO – 978-3-659-38508-7
Novel Device Enables Direct Measurement of Antibody Titers Up to 10 g/L in Real Time Without Sample Manipulations (Poster)
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