BrightOwl Loader Loading

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.
    • 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

Similar Candidates

Other Candidates in Malaysia

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like