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Summary

Prashant S Khemariya (Ph.D., M. Pharmacy)

Passionate about product development.

(Manager- Formulation; US, EU and SEA market).

 

[7 Awards, 20+ Publications with 9 years of rich research experience in-Pharmaceutical and Biotech (Protein-Peptide) drug delivery systems including NDDS with global regulations-INDA, NDA, ANDA, PAT, SUPAC, FDA, GMP, GLP, MHRA, TGA, USFDA, ICH, QSR, CFR-21.]

Experiences

Current Experience

  • Manager-Formulation and Development George Town Penang Malaysia
    Since July 2015

    • Leading R&D Team from its inception to develop a range of lifesaving products and medical device as per market demand.
    • Evaluate literature, patents and develop non-infringement strategies.
    • Follow Quality by Design (QbD) concepts for development as per FDA guidance and company standards.
    • Process Analytical Technology implementation and life cycle management with respect to QbD, CPP, CQA to enhance the quality and productivity of upcoming products.
    • Prepare pilot scale batches in pilot lab to determine a suitable process which will yield stable product.
    • Conduct stability on lab scale batches and interpret data to develop sound conclusions.
    • Support in analytical method development (HPLC, UV, Micro etc.) and In vitro/In vivo (BE) study.
    • Process development and optimization including scale-up for commercialization -Spheronization, Pelletization, Coating, MUPS and all Dosage form, Tech-transfer of products at manufacturing site.
    • Development of techniques for taste masking of bitter drugs for formulation of dosage form.
    • Development of new technologies & advances in Lyophilization, oral liquid / solid (syrup, suspension) or semisolid formulations by defining target, product profile (from cost, quality manufacturing point of view).
    • Development of techniques as co-crystallization and co-solvency for improvement of dissolution of poorly soluble drugs.
    • Providing technical leadership on project teams and task groups Validation documentation (CV/PV scheme and report).
    • Evaluation and approval of all documents per FDA, GMP, cGMP, GLP Guidelines (Preformulation study,SOP,BMR).
    • Ensure the proper functioning and maintenance of SOPs for laboratory equipment.
    • Maintaining routine procedure for the calibration of analytic equipment’s.
    • Support Heath Authorities audits evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
    • Assists in executing development study plan for NDA and
    • Collaborate with team members (formulators and analytical chemists) to meet timelines for product development activities. Cost reduction of the pre-launched/marketed products.
    • Perform other duties as required or necessary.

Past Experience

  • Sr Research Scientist Mumbai, Maharashtra, India
    June 2010 --- July 2015

    • Providing technical leadership on project teams and task groups Validation documentation (CV/PV scheme and report).
    • Evaluation and approval of all documents per FDA, GMP, cGMP, GLP Guidelines (Preformulation study,SOP,BMR).
    • Ensure the proper functioning and maintenance of SOPs for laboratory equipment.
    • Maintaining routine procedure for the calibration of analytic equipment’s.
    • Support Heath Authorities audits evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
    • Assists in executing development study plan for NDA and

  • Research Scientist Indore, Madhya Pradesh, India
    May 2009 --- June 2010

    • Assists in executing development study plan for NDA and
    • Collaborate with team members (formulators and analytical chemists) to meet timelines for product development activities. Cost reduction of the pre-launched/marketed products.
    • Perform other duties as required or necessary.

Personality

Self Assessment :
Self-confidenceSelf-disciplineResponsibilityInnovative thinking

Knowledge

Self Assessment :
Biostatistics Cell biology Biochemistry DiabetesProduct developmentGMPFDABiological Drug Development

Skills and Expertise

Self Assessment :
Establish contracts Technology researchSearch literature on clinical trialsRelease productsRegulatory submissionsRegulatory documentation

Education

  • PhD in Pharmacy from JNU in 2018
  • M Pharmacy in Pharmacy from RGPV India in 2010

Languages

BrightOwl Assessment:
Self Assessment:
English
Native

Work Preferences

  • Positions I am interested in:
    R&D manager
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

George Town Penang Malaysia

Others

Driving License
  • Yes