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Manager Product Development

Location:
Gelugor, Penang, 11700, Malaysia
Salary:
80000
Posted:
August 10, 2018

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Resume:

My designation and experience are responsible to be active in drug product development and lead the team to meet the needs of customers, their projects and commercial production. Ability of responsible for commercial formulation development & optimization, scale-up, process development, optimization, validation and technology transfer. Preparation and approval of documents for regulatory filing and input for commercial production.

Industrial Experience: - over 10 years-

1.May 2009 till May 2010- Ranbaxy Lab Limited at Dewas, India worked as Research trainee.

2.May 2010 till June 2015- Human BioSciences USA (SRK Pharmaceuticals) at Mumbai India, worked up to as Sr. Research scientist formulation and development.

3.July- 2015- still in Malaysia- with Hovid and KCK Pharmaceutical working as Manager-R&D, formulation development.

Work Effectiveness: -

1.Tablets, Ophthalmic, Capsule, Pellets. Taste Masking, Film Coating

2.Parenteral, Creams, MUPS, Syrup Stability and solubility enhance

3.Microencapsulation Techniques Collagen Type I (Lyophilization)

4.Silver Nanoparticle/Liposome Artificial RBC/ Mosquito Free City

5.Confidential project-carbon nanotube for ophthalmic, collagen lenses, Syrup-in-Suspension, Iron coated liposome and magnetic belt for cancer treatment, fast growing cells for burn patient.

Responsibilities: -

Lead research team of 11 scientists, from its inception to develop a range of lifesaving products and medical device as per market demand.

Evaluate literatures, 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.

Preparation of pilot scale batches in pilot lab to determine a suitable process which will yield stable product.

Conduct stability study 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, Ophthalmic, Parenteral, 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 (Pre formulation study, SOP, BMR).

Ensure the proper functioning and maintenance of SOPs for laboratory equipment.

Maintaining routine procedure for the calibration of analytical 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 ANDA.

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.

Skills: -

Qualifications: -

2004-2008: - B. Pharmacy in Pharmaceutics (from Bhopal India).

2006-2008: - CCA (Diploma in Computer application).

2008-2010: - M. Pharmacy in Pharmaceutics (from Bhopal India).

2014 – Pursing: - PhD in Pharmaceutics (From JNU India).

Rewards: -

1.2016- “Best international publication” award from Human Biosciences Inc.

2.2015- Best Team Leader.

3.2014- Reward- Best Performance in Development of Stable Products at SRK Pharmaceuticals.

4.2011-Reward- Best performance employee at SRK Pharmaceuticals.

5.2010-2011 Reward- successful development of largest no. of products at SRK Pharmaceuticals.

6.2010 only Indian Pharmacy Student (research trainee at Ranbaxy) who has been selected in Novel Drug Delivery Conference “Liquid filling in two pieces hard gelatin capsule” at France.

7.Secured 2nd position- in Poster presentation on “Monoclonal antibodies: -A Magic Bullet or Just a Trigger” at National Seminar 2009 at ADINA Sagar MP.

8.Secured 2nd position- in Paper Presentation on “Floating Drug Delivery System” at National Seminar-2010 at LNCT MP.

International/ National Publications: -

1.Prashant Khemariya, Kaushal Dubey and Richa Khemariya, “Innovative approach to sustain the release of the drug from conventional dosage form- Nifedipine SR Tablet”. Journal of Nanomedicine and Nano Science. JNAN 115, Volume 2017 Issue 02.

2.Khemariya Prashant, Khemariya Richa and Jain Amit, “An exclusionary approach to recover iron deficiency by POLYROL an over view of iron polymaltose complex" International Journal of Advanced Research in Biological Sciences, ISSN: 2348-8069, Volume 3, Issue 4 – 2016, 183-188.

3.Prashant S Khemariya and Richa P Khemariya “Comparative Evaluation of Efficacy of Pure Collagen Type I Based Modern Dressing with Conventional Dressing in the Treatment of Burn 5 and Diabetic Foot Ulcer” in International Journal of Current Research in Biosciences and Plant Biology (Feb.- 2016).

4. Prashant S Khemariya and Richa P Khemariya “New-Fangled Approach in the Management of Alzheimer by 4 Formulation of Polysorbate 80 Coated Chitosan Nanoparticles of 5 Rusvastigmine for Brain Delivery and Their in-vivo Evaluation” in International Journal of Current Research in Biosciences and Plant Biology (Feb.- 2016).

5.Prashant S Khemariya “Formulation of Iron coated Liposomes of SERM and design development of magnetic belt for the management of breast cancer during earlier stages and protection from invasive cancer” accepted by International Drug Delivery Submit 2015, An international conference in Houston USA.

6.P Khemariya, H S Choudhary and R John “A ground-breaking and triumphant way to disappearance the wound- Collagen and their Life saving Products” under publication.

7.Prashant Khemariya “Aspirin in Combination with An amino Acid to enhance their Bioavailability and antiplatelet drug efficacy” under publication.

8.Prashant Khemariya, Rajan John, Ragani Maharotra, Rajani Paramhas “An over view – How to be safe and healthy Pregnancy” published in Earth Journal of Social Science- January-2015 ISSN 231*-****-** Volume 3.

9.Choubey Shivani, Vyas Suresh Prasad and Khemariya Prashant “Effective antibiotics and ATP loaded delivery System in the management of Diabetics wound” in Int. J. Curr. Microbiol. App.Sci (2013) 2(9).

10.Prashant K and Amit K J “An innovative approach to prolong gastric retention“Floating microspheres of cimetidine hydrochloride” in Global Advanced Research Journals (August-2012).

11.P. Khemariya “A Pioneering Approach to Enhance Dissolution and Bioavailability of Multiple Drugs in a Single Dosage Form: Speedy Disintegrating Tablet of Cefpodoxime Proxetil and Potassium Clavulanate” in Journal of Advanced Scientific Research (July-2012).

12.Research Paper - Novel approach to enhance bioavailability of poorly aqueous soluble drugs- “Liquid Filing in Two Piece Hard Gelatin Capsule” in 2nd Conference- Innovation in Drug Delivery: From Preformulation to Development through Innovative Evaluation Process in France (Dec.-2010).

13.P. Khemariya, M. Bhargava and S. Goswami “Preparation and In-Vitro Evaluation of Sustained-Release Matrix Tablets of Diltiazem” Published in International Journal of Advances in Pharmaceutical Sciences (October-2010).

14.P. Khemariya and S. Goswami “Formulation and Characterization of Sustained Release Gastro retentive Drug Delivery System of Ofloxacin” Published in International Journal of Advances in Pharmaceutical Sciences(October-2010).

15.P. Khemariya, A. Jain, R. Goswami and Mohit Bhargava- “Advances In Novel Drug Delivery Carriers: Formulation and In Vitro Evaluation of Solid Lipid Nanoparticles of Nateglinide” Published in International Journal of Pharmaceutical and Applied Sciences (June-2010).

16.Prashant Khemariya, and Mohit Bhargava- “An emerging trend in tablet technology: - Floating Tablets of Ranitidine HCl” Published in International Journal of Drug Delivery (May -2010).

17.Prashant Khemariya, Mohit Bhargava and Sanjay Goswami -“Preparation and evaluation of “Mouth Dissolving Tablets of Meloxicam” Published in International Journal of Drug Delivery (Jan -2010).

18.Prashant Khemariya, Rajesh S. Jadon, Swadesh Nayak, Sabita Amlan, Vikas Deep Vaidya, Sandip Sumbhate, S. Nayak.- “Taste Masking of Lornoxicam by Polymer Carrier System and Formulation of Oral Disintegrating Tablets” Published in International Journal of Drug Delivery (May-2009).

19.Prashant Khemariya -“An over view of Drug Receptor Interaction” Published in Journal of Pharmacology (March-2006).

Information

Language- English.

Prashant S. Khemariya

Prashant Khemariya (PhD. M. Pharmacy, CCA)

Passionate about product development.

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

50+ Products 7+ Awards 20+ Publications

in the market

10 years of rich research experience in – Pharmaceutical and Biotech (Protein-Peptide) drug delivery systems including CMC, NDDS with global regulations.

Notice Period - one week.

Citizenship- Indian.

Þ- Penang, Malaysia.

: :- ac6mbl@r.postjobfree.com

( : +60-142******.

Skype:- ac6mbl@r.postjobfree.com

GMP, cGMP

ICH Guidelines, SUPAC

QMS, USFDA, TGA, Eudralex EC, PMDA

Code of Federal Regulations (CFR21)

Positive and can do attitude

NDA, ANDA, MHRA

Audit, contract, loan license mfg.

Integrity, Empathy and Sympathy

Team leadership

Motivation- Self / Team

Project management

NDDS

Passion through enthusiasm.



Contact this candidate