Manager Project
Resume:
SHAMREZ ALI.M
M.Pharm., Ph.D Mobile: +91-990*******
Mobile No: +91-992*******
**********@*****.***
New Bank Colony, Bilalabad
Gulbarga -585104, Karnataka,INDIA.
PROFESSIONAL SUMMARY
________________________________________A practicing Formulation Researcher with over 9 years; 5 years in India and 4 years in abroad. With extensive experience in Formulations Research & Development, project management, Analytical development and quality assurance works in various international and fast track projects of (ANDA, RoW, MoH, Trouble Shootings). Had managed cross functionally, single point delivery of projects with meeting product development timelines.________________________________________
WORK EXPERIENCE________________________________________
Dec. 2009 - Present SIMPEX PHARMA PVT LTD, Uttarakhand, India.
Dy.General Manager, Formulations Research & Development
• Strategic planning, discussion with marketing for the selection of the projects and Technical feasibility of the project (SWOT).
• Innovation into the products to see the novelty and product differentiation.
• Development Timeline and Development Process planning
• Master Project Plan, Development Plan ,Test Plan, Test Specification, Communication Plan, Operations Plan, Availability Plan, Capacity Plan, Monitoring Plan, Training Plan, Purchasing and Facilities Plan, Pilot Plan, Budget Plan
• Product development Review and Strategy with Technology transfer from FR&D and AR&D to production and QC
• Coordination with various linked departments like QA, Analytical, Supply chain management, Regulatory Affairs and Packaging Development
• Co-ordination, planning In-vitro Studies, Bio-Studies and evaluation & Scale-up studies, Validation & supervision of first three batches
• Integration of inputs from R&D, AR&D, Process Development, IP team members and other team members
• Development of the Non-Infringing formula for various regulated market
• Ensures the completion of snags and Coordinates requirements of handing over close out documentation.
• Support the Delivery Head for risk assessment and mitigation
Accomplishments:
Developed a non infringing formulation of Leflunomide tablets and worked on various other orphan drugs development like Terizidone , Tilorone and Arbidol and development of various other 25 formulation projects, having innovation like Co-Crystal technology in improving the physiochemical and mechanical properties of Formulation, Polymorphic crystal studies, Solid State Characterization
Heading a Team of: 7 formulation Development Specialists and 4 Analytical Specialists.
Feb. 2005 – Dec. 2009 MEDPHARMA Pharmaceutical Sharjah , U.A.E
Manager, Formulations Research & Development
• Responsible for R&D Affairs Formulation development, planning, scheduling, Regulatory
planning, Idea generation strategic affairs (Outsourcing & In licensing)
• Development Timeline and Development Process planning
• Master Project Plan, Development Plan ,Test Plan, Test Specification, Communication Plan,
Operations Plan, Availability Plan, Capacity Plan, Monitoring Plan, Training Plan, Purchasing
and Facilities Plan, Pilot Plan, Budget Plan
• Developed around 65 formulations of various dosage forms, with product differentiation and
patentable option.
• Regulatory submissions all over Middle East & North Africa (MENA). Taken the focus of
company from a standard strategy to an innovative thinking.
• Implemented strict development discipline, with an effective planning and execution of
programmed work to avoid disruptive and abortive timelines of projects.
• Co-ordination, planning In-vitro Studies, Bio-Studies and evaluation & Scale-up studies, Validation & supervision of first three batches
• Integration of inputs from R&D, AR&D, Process Development, IP team members and other team members
• Development of the Non-Infringing formula for various regulated market
• Ensures the completion of snags and Coordinates requirements of handing over close out documentation.
• Support the Delivery Head for risk assessment and mitigation.
Accomplishments:
• Developed around 65 formulations of various dosage forms, with product differentiation and patentable option.
• Tablet Dosage Form (9 Projects)
• Semisolid Preparation (21 projects) ,
• Capsules (10 projects)
• Dry powder For suspensions (9 Projects) (Critical Stability and Taste masking)
• Syrups & Liquids (20) (Stability and interaction Studies & Troubleshooting)
• Successful Bio-Study (9 products)
Heading a Team of: 7 formulation Development Specialists and 4 Analytical Specialists.
Mar. 2004 – Apr. 2005 DR.REDDY’s LABORATORIES FORMULATION R&D (IPDO) Bachupally, Hyderabad, India.
Junior Manager FR&D
•Define and Establish detailed Project Execution Phases, sequencing of activities in coordination with the Sr.Manager and coordination the defined task with Project Manager.
•Prepares and submits development-related reports to senior staff.
Maintaining Construction Schedules and various resource requirements to meet the required progress and production requirements and establish close communication with the Materials Engineer/Warehouse regarding material submittals/approvals, on site and stores receipt and clearance.
• Developing formulations with patent non-infringing route.
Accomplishments:
• Worked on MUPS formulation.
• Conducting PE/BE studies of existing formulation for the Regulated and semi regulated countries.
• Set-up Formulation Specification, Raw material etc.
• Exhibit & Scale Up batches.
• Trouble shootings.
Jan. 2003 – Mar. 2004 Aristo Pharma Bhopal, India
Research Pharmacist
•worked in core team to resolve the technical
Accomplishments:
1. Worked on solid and semisolid formulations
2. Interpretation of stability and other analytical data
3. Exhibit & Scale Up batches.
4. Studying Pharmacokinetic properties of molecules.
5. Trouble Shooting.
Highlights : Developed Valdecoxib gel, Aceclofenac Gel-o-Cream and Developed progesterone Sustained release Gel for vaginal delivery, we did in-vitro and Vivo studies in NIPER (Mohali)
Aug 1999 - Jan 2001 GILMAN LABS Hyderabad
Production Pharmacist
• Worked with in their production department as Production Pharmacist.
EDUCATION ATTAINMENT________________________________________
B. Pharm. From Gulbarga University, Gulbarga. (Karnataka) with First Class.
M. Pharm. From Rajiv Gandhi University of Health Sciences, Bangalore (Karnataka) with First Class. Ph.D From K.L.E college of Pharmaceutical sciences, Karnataka, and VM University, T.N. India.
PRESENTATION/PUBLICATION/PATENT/CONFRENCES ATTENDED ________________________________________
Scientific PUBLICATIONS
4 national and international publications
Scientific PRESENTATIONS
3 national and international presentations
Latest publications
1. M Shamrez Ali , BK Nanjwade , FV Manvi : Effect of Tropical Climatic Conditions: On Stability of Dry Powder for Suspensions; Trop J Pharm Res , February 2010; 9(1): 73-79.
2. M Shamrez Ali , BK Nanjwade, FV Manvi (2010) Effect of Compression Pressure on Dissolution and Solid State Characterization of Cefuroxime Axetil. J Anal Bioanal Techniques 1:112. doi:10.4172/2155-9872.1000112.
3. M Shamrez Ali ,A.Swati, Mishra AK, BK Nanjwade. Preparation and solid-state characterization of leflunomide polymorph along with its solubility assessment and dosage form dissolution 62nd IPC Dec 2010 , Manipal, Karnataka.
4. M Shamrez Ali , BK Nanjwade , FV Manvi : A new stability indicating RP-HPLC method to determine Etamsylate in injection formulation. Sci Pharm, 2010.
Patent Filled
SHAMAREZ ALI M, BK Nanjwade ; Enhancement of Oral Bioavailibility of Non Aqueous Formulations of Prodrug Esters with Medium Chain Triglycerides application No 2788/MUM/2010 A International classification :A61K31/00
(This patent is under discussion with The IC Institute of Texas University Austin for commercialization) Technology has been selected among the top 30 under the DST-Lockheed Martin India Innovation Growth Programme 2011, a joint collaborative effort of FICCI and University of Texas , Austin. USA.
LATEST EXPERTISE AND AREA OF INTEREST
Formulations development on various NCE.
Enhancement of Bio-availability by reducing the Food Effect using MCT’s
Co-Crystal technology in improving the physiochemical and mechanical properties of Formulations
Polymorphic crystal studies, Solid State Characterization
Controlled release systems
Dry Powder properties.
Bio-Studies of Solid Orals and Topical Formulations
AFFILIATON AND MEMBERSHIP ________________________________________
Registered Pharmacist (R.Ph) with karnataka state pharmacy council, Bangalore
IT SKILLS ________________________________________
Window & Office Tools
• Microsoft Word 2007 • Proficient
• Microsoft Excel 2007
• Microsoft Project • Proficient
• Workable
• Power Point • Proficient
• SAP • Proficient
Non-web Programming Language
• ERP software
• Scientific and Statistical software • Proficient
• Proficient
LANGUAGE ________________________________________
• English Fluent
• Kannada Native
• Telugu Working Knowledge
• Hindi
• Marathi
• Gujarati Fluent
Working knowledge
Working knowledge
PERSONAL PROFILE ________________________________________
• Civil Status: Married
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