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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 10 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
    o lead Research team of 11 scientists, from its inception to develop a range of lifesaving products and Medical Device as per market demand. o evaluate literatures, Patents and develop non-infringement strategies. o follow quality by design (qbd) concepts for development as per FDA guidance and company’s standards. o process analytical technology implementation and life cycle management with respect to qbd, cpp, cqa to enhance the quality and productivity of upcoming products. troubleshoot production problems related with Formulation. o preparation of Pilot scale batches in pilot Lab to determine a suitable process which will yield stable product. o support in analytical method development (HPLC, UV, micro etc.) and In Vitro/In Vivo (be) study. o Process development and optimization including scale-up for Commercialization - spheronization, pelletization, coating, mups and all dosage form, tech-transfer of products at Manufacturing site. o development of techniques for taste masking of bitter drugs for Formulation of dosage form. o development of new technologies & advances in lyophilization, ophthalmic, parenteral, oral liquid / solid (syrup, suspension) or semisolid Formulations by defining target, product profile (from cost, quality Manufacturing point of view). o development of techniques as co-crystallization and co-solvency for improvement of dissolution of poorly soluble drugs. o providing technical Leadership on project teams and task groups Validation Documentation (cv/pv scheme and report). o evaluation and approval of all documents per FDA, GMP, cGMP, glp guidelines (pre Formulation study, SOP, bmr). o maintaining routine procedure for the calibration of analytical equipment’s. o assists in executing development study plan for nda and anda. o collaborate with team members (formulators and analytical chemists) to meet timelines for Product Development activities. cost reduction of the pre-launched/marketed products. o perform other duties as required or assigned by management. o Lead research team of 11 scientists, from its inception to develop a range of lifesaving products and medical device as per market demand. o Evaluate literatures, patents and develop non-infringement strategies. o Follow Quality by Design (QbD) concepts for development as per FDA guidance and company’s standards. o Process Analytical Technology implementation and life cycle management with respect to QbD, CPP, CQA to enhance the quality and productivity of upcoming products. Troubleshoot production problems related with formulation. o Preparation of pilot scale batches in pilot lab to determine a suitable process which will yield stable product. o Support in analytical method development (HPLC, UV, Micro etc.) and In vitro/In vivo (BE) study. o Process development and optimization including scale-up for commercialization - Spheronization, Pelletization, Coating, MUPS and all Dosage form, Tech-transfer of products at manufacturing site. o Development of techniques for taste masking of bitter drugs for formulation of dosage form. o Development of new technologies & advances in Lyophilization, Ophthalmic, Parenteral, oral liquid / solid (syrup, suspension) or semisolid formulations by defining target, product profile (from cost, quality manufacturing point of view). o Development of techniques as co-crystallization and co-solvency for improvement of dissolution of poorly soluble drugs. o Providing technical leadership on project teams and task groups Validation documentation (CV/PV scheme and report). o Evaluation and approval of all documents per FDA, GMP, cGMP, GLP Guidelines (Pre formulation study, SOP, BMR). o Maintaining routine procedure for the calibration of analytical equipment’s. o Assists in executing development study plan for NDA and ANDA. o Collaborate with team members (formulators and analytical chemists) to meet timelines for product development activities. Cost reduction of the pre-launched/marketed products. o Perform other duties as required or assigned by management.

Past Experience

  • Sr Research Scientist Mumbai, Maharashtra, India

    June 2010 --- July 2015
    • leaded a team of 4 junior scientists for 4 years.
    • developed new Formulation or reformulated existing products.
    • evaluated literatures, Patents and developed non-infringement strategies.
    • followed quality by design (qbd) concepts for development as per FDA guidance and company standards.
    • conducted stability study on Lab scale batches and interpret data to develop sound conclusions.
    • ensured the proper functioning and maintenance of sops for Laboratory equipment.

     

    • developed techniques as co-crystallization and co-solvency for improvement of dissolution of poorly soluble drugs.
    • stabilized type i collagen at rt and developed various products (patches, antiaging cream, silver Nanoparticles etc.)
    • developed new technologies & advanced in lyophilization, ophthalmic, parenteral, oral liquid / solid (syrup, suspension) or semisolid Formulations by defining target, product profile (from cost, quality Manufacturing point of view).
    • process developed and optimized including scale-up for Commercialization - spheronization, pelletization, coating, mups and all dosage form, tech-transfer of products at Manufacturing site.
    • sourced new raw materials required for new Product Development. prepared trial and pilot batches then transferred the technology to the commercial sites
    • developed and supported in artwork design for secondary pack.
    • performed other duties as required or necessary.

  • Research Scientist Indore, Madhya Pradesh, India

    May 2009 --- June 2010
     planned and executed daily Research activity  conducted wet and dry granulation process for various products, optimized the best granulation process.  supported and conducted pre Formulation study of tablet, capsule, and injectable preparation.  successful developed liquid filling process in two peace hard gelatin capsule.  conducted stability study on Lab scale batches and interpret data to develop sound conclusions.  ensured the proper functioning and maintenance of sops for Laboratory equipment.  followed quality by design (qbd) concepts for development as per FDA guidance and company standards.  developed alternative process for existing product to reduce the cost.

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

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