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Formulation development/process development of solid dosage forms

Location:
United States
Salary:
negotiable
Posted:
January 13, 2011
Email:
pkfn3x@r.postjobfree.com
Contact Info:
**************@*****.***


R. BALASUBRAMANIAN
Deputy Manager-R&D
Oman Pharmaceutical Products
OMAN
Mobile; 00968-95631597
Email: pkfn3x@r.postjobfree.com
Hi
Sub: Suitable position- Reg.

I am herewith enclosing my CV for the above position. Presently, I am working as Deputy Manager-R&D with 10 years of research experience in development of pharmaceutical formulations from conception to product release. I enclosed my curriculum vitae as a first step in exploring the possibilities of employment.

My most recent experience was developing the products to various non-regulated and regulated markets like US-FDA; UK-MHRA, TGA,EU, MOH-OMAN, GCC-GULF etc markets from conception through to stability studies. I am responsible for lead a group of R&D team and coordinating with Regulatory, Clinical; Marketing and Manufacturing departments to deliver the products within scheduled time. I have good knowledge in developing various kinds of SOLID DOSAGE FORMS (TABLETS & HARD GELATIN CAPSULES), LIQUIDS (SOLUTIONS, SUSPENSIONS and EMULSIONS) & TOPICAL (CREAMS/OINTMENTS & LOTIONS) and HORMONE PRODUCTS (SOLID DOSAGE FORMS).
I have good knowledge on effective project planning, project reviews and project reporting. I have the ability to organization and coordination of customer liaison and updates and project reviews in conjunction with product development and scientific affairs
I would appreciate if you keep this enquiry confidential. I would be grateful to you, if you would contact me. Thank you for your consideration.

Yours faithfully

(R. BALASUBRAMANIAN)

CURRICULUM VITAE

R. BALASUBRAMANIAN

Permanent Address: # 41, 3 rd Cross, Thanthai Periyar Nagar, Pondicherry 605005,
Tamilnadu – India.
Current Address: PO Box No. 2240, P.C. 211, Raysut Industrial Estate, Salalah,
Sultannate of Oman.
Mobile: +968-95631597 (Oman), 09940069265 (India)
Email: pkfn3x@r.postjobfree.com, pkfn3x@r.postjobfree.com, pkfn3x@r.postjobfree.com

SKILL SUMMARY: Experienced 10years in development of various types of dosage forms from conception through to stability for non-regulated and regulated markets like US-FDA; UK-MHRA, TGA,EU, MOH-OMAN, GCC-GULF etc. My expertises include supervision of R&D team and coordination with Marketing, regulatory affairs, clinical, Quality assurance and production departments and have very good knowledge in formulation improvement and process quality improvement. I have good knowledge on different kinds of dosage forms like SOLID DOSAGE FORMS (TABLETS, HARD GELATIN CAPSULES, OINTMENTS/ CREAMS, AND LIQUID DOSAGE FORMS and HORMONAL PRODUCTS. I have the ability to organization and coordination of customer liaison and updates and project reviews in conjunction with product development and scientific affairs.
EMPLOYMENT HISTORY
Oman Pharmaceutical Products Co.LLC,
Deputy Manager – R&D,
Feb 2007 – Till Date

Responsibilities:
• Management of Pharma R&D, for domestic and regulated market projects.
• Effective utilization of men, material and resources with proper planning and management.

• Ensure proper documentation of Pharmaceutical Development Report, Master formula records, Raw materials and Product Specifications for new products, Technical Data Package /Technology Transfer Dossiers.
• Responsible for coordination with QA and Regulatory cells.
• Responsible for providing support for process improvement of the already approved products in domestic markets.
• Aiding colleagues in Literature Survey through Internet, Journals and other Scientific Resources.
• Participation and guidance in Stability study, Preformulation studies as per Guidelines.
• Co-ordinating for documentation as per MHRA/USFDA norms.
• Guiding Scale up, Pilot Bio Scale batches, Process optimization batches and Exhibit batches at plant location.
• Providing technical support to Regulatory affairs in responding to the Agencies Queries regarding the filed dossiers.

Achievements:

• Successfully completed various Hormone formulations for a European collaborator (Exemestane, Desogestrel, Clomifene citrate…………….)
• Independently managed the R&D and Technology transfer cells, managing about 20 different projects.
• Coordinated, and managed projects for various clients, and completed their projects successfully on & before projected timelines.
• Successfully completed products for US markets including Hormone products.

Shasun Chemicals & Drugs Ltd, Pondicherry, India,
Officer- Formulation & Development
APR 2005 – JAN 2007
Responsibilities:
• Formulation and development of pharmaceutical dosage forms for regulated markets.
• Literature Survey through Journals, Internet and Scientific Resources.
• Stability study, Pre-formulation studies as per Guidelines.
• Master Formulation Card preparation, Feasibility report & Product Development summary.
• Scale up, Pilot Bio Scale batches, Process optimization batches and Exhibit batches at plant location.

Achievements:

• One anti ulcer project completed up to exhibit batch.
• One Cardiac project completed up to exhibit batch.
• One Cardiac project with diuretic combination completed up to exhibit batch.
• One antihistaminic project completed up to exhibit batch.
The above projects were executed for U.S. as well as Europe market.

Aurobindo Pharma Research Centre, Mumbai, India,
Research Associate- Formulation & Development
JAN 2004 – MAR 2005
Responsibilities:
• Formulation development of US (ANDA) Projects as per Regulatory requirements.
• Formulation development of Oral solid dosage forms incl. Novel drug delivery systems.
• Literature Survey through Internet, Journals and other Scientific Resources.
• Stability study, Preformulation studies as per Guidelines.

Achievements:
• One Anti retroviral project had been successfully completed up to Exhibit batch.
• One Diuretic project had been successfully completed up to Exhibit batch.
• One of CNS stimulant project up to Scale up and optimization had been completed.
• The above mentioned projects had been done for U.S market as an ANDA product development, are Bio equivalence test passed.
Credentials:
• Attended product development related seminars delivered by our collaborating organizations on research projects. Attended Excipients seminar from BASF, COLORCON, ISP Technology, Parle tools and DEGUSSA Polymers.

Micro Labs Ltd, Hosur, Tamilnadu, India,
Research Associate,
JUN 98 – DEC 2000 & JAN 2003 – DEC 2003
Responsibilities:
• Formulation and development of pharmaceutical dosage forms for regulated & semi-regulated markets.
• Literature Survey through Internet, Journals and other Scientific Resources.
• Stability study, Pre-formulation studies as per Guidelines.
• Master Formulation Card preparation, Feasibility report & Product Development summary.
• Scale up, Pilot Bio Scale batches, Process optimization batches and Exhibit batches at plant location.
Achievements:
• Development of a range of anti tuberculosis projects for semi regulated markets.
• Successful completion of proton pump inhibitor project for UK market, as a controlled release delivery.
• On time completion of two antiretroviral projects for UK market as well as semi regulated market.
PROFESSIONAL/ DEVELOPMENTAL TRAININGS:
• 5 days Training in Advance Excel Programme.
• 3 days In House training on Leadership at Oman Pharmaceuticals…& many other trainings on various topics.
• 3 days training by Colorcon advanced coating system
• 1 day training by BASF polymer system
EDUCATION:
• Bachelor of Pharmacy, (Yr 1993 – 1997) from J.K.K.M.M.R.F. College of Pharmacy, Komarapalayam, Namakkal (D.T), Dr. M.G.R. Medical University, Tamil Nadu, India.
• Masters of Pharmacy (Pharmaceutics), (Yr 2001 – 2002) from K.M. College of Pharmacy, Madurai, (D.T) . Dr. M.G.R. Medical University, Tamil Nadu, India.

References

A.K.Sekhar, Director, QA/RA, Essai Pharmaceuticals, Vishakhapatnam, Andhra Pradesh. Contact details: pkfn3x@r.postjobfree.com

Dr. B. Sreenivasarao, Manager Research & Development,
Oman Pharmaceutical Products Co.LLC. Salalah, OMAN
Email: pkfn3x@r.postjobfree.com.