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Regulatory affairs and PhD

Location:
Mississauga, ON, Canada
Posted:
April 28, 2020

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Resume:

Padmaja Nipanikar-Gokhale

PhD and Regulatory Affairs

PROFILE

An enthusiastic science graduate with PhD and 10 years of R & D experience (Pharmaceutical and Biotechnology industries). Working towards developing a career in Pharmaceutical Regulatory Affairs.

Well-versed with Food and Drug Regulations (FDR) Canada, GMP and ICH guidelines, Health Canada policies and interpretations, CTD/eCTD formats, NDS, CTAs, MF, CMC, NHP and Medical devices regulations (MDR), International Regulatory Affairs (FDA, EMA), Product Life Cycle management, Drug development and approval process by Health Canada

Expertise in molecular biology and drug discovery. Knowledge of Biotech/Pharma product development. Experience of manuscript preparations, Scientific/Technical writing and proficient in Microsoft Office (Word, Excel, PowerPoint)

EDUCATION

May 2019 – Dec 2020 Seneca College, Ontario College Graduate Certificate Toronto

in Regulatory Affairs and Quality Operations

Trained in the following through course assignments.

Development of Regulatory strategies (Canada/Global)

Regulatory communications with Health Canada ( meeting requests, request for expedited review, pre-meeting documentation, Clarifax response writing)

Product monograph preparation

DIN, EL submissions

QOS, CMC, CTA preparation

New Drug submissions (NDS), SNDS applications

Global regulatory submissions/strategies

PAAB, labelling regulations

Medical devices applications (Canada/Global)

Basics of Quality Assurance (SOP writing, change control management, GMP deviation management, CAPA management)

Jan 2007 – Apr 2013 University of Mumbai, Ph.D (Molecular Biology) Mumbai, India

Characterized a novel hemerythrin protein Alr3199 from Anabaena sp. strain PCC 7120. Biochemical characterization revealed that it possesses DNase activity. Its structure was predicted using in silico tools. The protein was designated as HE-DNase by us

Alr3199 protein was found to be a stress induced protein which was also confirmed by analysis of its putative promoter

Any alteration in the normal expression levels of Alr3199 resulted in unique phenotypes and was detrimental to Anabaena, suggesting Alr3199 is essential for survival of Anabaena 7120.

SOFT SKILLS

Motivated and optimistic individual, Self-starter, proactive team worker and believer in continuous learning

Team management and mentoring

Excellent organizational, communication and time management skills

Multitasking and can work under demanding deadlines

Detail oriented and Analytical thinker for problem solving

EMPLOYMENT HISTORY

Jun 2018 – March 2020 Associate Metabolic Engineer, Phycus Biotechnologies Toronto

Successfully engineered bacterial strains for industrial production of biochemicals

Developed and implemented strain engineering methods, SOP writing

Planning, execution and presentation of scientific work supported by literature search

Oct 2012 – Jan 2017 Staff Technologist, Praj Industries Pune, India

Sub-Lead Molecular Biology team, assisted in project / grant proposals, manuscript and SOP writing

Trained and managed multiple strain engineering projects simultaneously

Developed a bacillus strain for enhanced production of 2,3 Butanediol (2,3 BDO). Overexpression of bdhA lead to 11% while co-factor engineering resulted in 26% increase in 2,3 BDO yield

Developed a Lactococcus strain for improved biochemical titer. Increase in copy number of a targeted gene resulted in 95% increase in productivity

Successfully engineered an E.coli strain for industry applications

Oct 2005 – Feb 2007 Scientist, Oncology drug discovery, Piramal Industries Mumbai, India

PROFESSIONAL ASSOCIATIONS

CAPRA and PSG

PUBLICATIONS

Engineering of Bacillus subtilis for Production of 2,3-Butanediol from Sugarcane Molasses. Appl Biochem Biotechnol, 2016, Deshmukh AD, Nipanikar-Gokhale Padmaja, Jain R 2016 May;179(2):321-31. doi: 10.1007/s12010

A novel hemerythrin DNase from the nitrogen fixing cyanobacterium Anabaena sp. strain PCC 7120. (Arch Biochem Biophys, 2011), 505 (2011) 171-177). 1st Author.

Nucleotide Sequence data published in GenBank, Accession Number FJ543111, 1st Author

Protein Sequence data published in Protein Database Accession Number Q8YS92, 1st Author

Bacillus amyloliquefaciens strain 10456, whole genome shotgun sequencing project, GenBank: MSBV00000000.1, 1st Author

Lactococcus lactis subsp. lactis strain ATCC 11454, whole genome shotgun sequencing project GenBank: MSFJ00000000.1



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