BrightOwl Loader Loading

Summary

prashant s khemariya (ph.d., m. Pharmacy)

passionate about Product Development.

(manager- Formulation; us, eu and sea market).

 

[8 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
    • responsible to lead, manage and motivate the team of brilliant Research scientists, from development till the Commercialization of a wide range of lifesaving drug products and process as per market demand (early and late stage).
    • evaluate literatures, Patents, reference product profile and monograph and develop non-infringement strategies.
    • follow quality by design (qbd) concepts, FDA guidance and company’s standards for development.
    • pre-Formulation study, feasibility data, stability study (as per ich/supac/npra) and Planning for primary packing as per availability of equipment and respective change parts.
    • preparation of trial and Pilot scale batches in pilot Lab to determine a suitable and robust process (using Engineering principles and methodologies) which will yield stable product at the commercial site.
    • responsible for drug product process Characterization, optimization and Technology transfer from Laboratory to the soft floor. scale-up & variations as per
    • process analytical technology implementation and life cycle management with respect to cpp, cqa to enhance the quality, efficacy and productivity of products.
    • responsible for implementation and maintain a state of the art Process development
    • provide technical Leadership on project teams and task groups validation (process validation, Cleaning Validation, filter validation, filling validation, hold time study for products and equipment, science)" rel="nofollow">Protocol, report and scheme) and post activity.
    • support in analytical method development (HPLC, UV, micro etc.) and In Vitro/In Vivo (be) study.
    • development of new technologies & advances in parenteral, oral liquid (syrup, suspension), ophthalmic, oral solid and semisolid Formulations by defining target, product profile.
    • development of techniques as like, dendrimer, co-crystallization, lyophilization, and co-solvency for improvement of solubility of poorly soluble drugs for parenteral dosage form.
    • development of techniques for taste masking of bitter drugs for Formulation of oral dosage form.
    • provide support on the soft floor during production and Troubleshooting.
    • review and approval of all documents per FDA, GMP, cGMP, glp guidelines (SOP, bmr products quality review, capa, Change Control, deviation).
    • maintaining routine procedure for the calibration and validation of instrument and equipment respectively.
    • assists in executing development study plan for nda and anda.
    • collaborate with team members (formulators and analytical chemists) to meet timelines for Product Development activities. cost reduction of the pre-launched/marketed products.
    • vendors Qualification and perform other duties as required or assigned by management.
    • Responsible to lead, manage and motivate the team of brilliant research scientists, from development till the commercialization of a wide range of lifesaving drug products and process as per market demand (early and late stage).
    • Evaluate literatures, patents, reference product profile and monograph and develop non-infringement strategies.
    • Follow Quality by Design (QbD) concepts, FDA guidance and company’s standards for development.
    • Pre-formulation study, feasibility data, stability study (as per ICH/SUPAC/NPRA) and planning for primary packing as per availability of equipment and respective change parts.
    • Preparation of trial and pilot scale batches in pilot lab to determine a suitable and robust process (using engineering principles and methodologies) which will yield stable product at the commercial site.
    • Responsible for drug product process characterization, optimization and technology transfer from laboratory to the soft floor. Scale-up & variations as per
    • Process Analytical Technology implementation and life cycle management with respect to CPP, CQA to enhance the quality, efficacy and productivity of products.
    • Responsible for implementation and maintain a state of the art process development
    • Provide technical leadership on project teams and task groups Validation (process validation, cleaning validation, filter validation, filling validation, hold time study for products and equipment, protocol, report and scheme) and post activity.
    • Support in analytical method development (HPLC, UV, Micro etc.) and In vitro/In vivo (BE) study.
    • Development of new technologies & advances in Parenteral, oral liquid (syrup, suspension), Ophthalmic, oral solid and semisolid formulations by defining target, product profile.
    • Development of techniques as like, dendrimer, co-crystallization, lyophilization, and co-solvency for improvement of solubility of poorly soluble drugs for parenteral dosage form.
    • Development of techniques for taste masking of bitter drugs for formulation of oral dosage form.
    • Provide support on the soft floor during production and troubleshooting.
    • Review and approval of all documents per FDA, GMP, cGMP, GLP Guidelines (SOP, BMR Products Quality Review, CAPA, Change control, deviation).
    • Maintaining routine procedure for the calibration and validation of instrument and equipment respectively.
    • Assists in executing development study plan for NDA and ANDA.
    • Collaborate with team members (formulators and analytical chemists) to meet timelines for product development activities. Cost reduction of the pre-launched/marketed products.
    • Vendors qualification and perform other duties as required or assigned by management.

Past Experience

  • Sr Research Scientist Mumbai, Maharashtra, India

    June 2010 --- June 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
    • sourced new raw materials required for new Product Development.
    • prepared trial and pilot batches then transferred the technology to the commercial sites.
    • performed other duties as required or necessary.
    • planned and executed daily Research activity
    • 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.
    • 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 Pursuing in Pharmacy from JNU in 2019
  • 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

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

George Town Penang Malaysia

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Malaysia

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like