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Biography:
1707-A; Scotch brook Drive
Philadelphia. PA 19115
Home: (215) 698-7464
Cell: (203) 240 2900
syedaqilhusain@yahoo.com

Pharmaceutical R&D, Clinical, and Production experience with achievement of over 50 ANDAs approved. Professionally thorough with extensive experience in Pharmaceutical R&D, Manufacturing, Production, Process Improvement, Technical Services and Trouble Shooting. An innovative and results oriented Pharmaceutical Scientist with over 30 years experience in R&D, production, technology transfers, and process improvement for new and existing products. Proficient in cGMP. Excellent communication skills, able to work independently and to coordinate multidisciplinary teams.
Delivered outstanding value to life for upgrades in Pharmaceutical world. Possesses a clear vision in achieving Corporate Mission and Values with emphasis on Quality, Integrity, Leadership, Collaboration, and Achievement of Common Goals. Commitment to the team concept and focus groups.

Areas of Expertise
 Development of oral solid dosage forms (tablets, capsules, suspension, solutions) .  Scale-up, Pilot Batches, Production Batches, Technology Transfer, Validation
 Data Evaluation and Technical Reports  Batch Records Preparation
 Fluid bed coating (Sustained Release products, Time Release, and Modified Release)  Clinical Batch Manufacturing, Collaboration with all departments for NDA/AND Submission
 Formulation Development, Protocol design and execution  SOP’s and Manufacturing Investigation Reports. Root Cause Analysis and Provided Solution/Conclusion
 Multivariable Pharmaceutical Problem Solving.  Developed Various Modified Release System

PROFESSIONAL EXPERIENCE AND ACCOMPLISHMENTS
Wyeth International Pharmaceuticals, Rouses Point, New York 2002-2004
Principal Scientist & MIR Lead Investigator,
(Transferred from Wyeth Pearl River NY to Rouses Point NY, Facility in 2002)
Investigated production challenges, identified causes of problems/failures, suggested solutions, wrote protocols for investigations, and wrote reports of investigations.
Created Pharmaceutical Products Manufacturing Investigation Reports. Concluded possible deviation, root causes, identified affected areas. Provided Technical supports and corrective action plans. Developed innovative approaches to solving process related problems.
Reviewed and provide consultation. Recommended development Process and Validation Procedures. Prepared Technical Reports/Protocols. Coordinated production activities with production, tech services, analytical lab and quality operations to ensure monthly targets were met...Initiated/Finalized study on production challenges; identified major agents affecting dissolution of product through series of investigations; employed parallel coordinate plots and regression analysis.
Initiated a protocol for investigative study of aspects of raw materials which can predict dissolution behavior of raw material lot.
SYED AQIL HUSAIN Page 2
Wyeth-Ayerst Pharmaceuticals (American Home Products, Generic Division, ESILederle),
Pearl River, NY
Principal ResearchScientist (Highest Scientific Level Achieved) 1996-2002
Project Achievement: Products developed and achieved ANDAs approval as #1 product in the US Market for consecutive 15 years. Performed/Planned independently R&D, Scale-up and Production in cGMP pilot plant, in USA, Canada and contract manufacturing facilities; managed highly skilled team of scientists in Formulation Development and Technical Services and production operations at different stages of development. Established Standard Operating Procedures for various methods of manufacturing and techniques for the ANDAs products.
 Served as a Lead Scientist in research activities for drug product process development, project manager role in Pharmaceutical Research and Development working with interdisciplinary groups within the company.
 Provided, assisted in technology transfer from pilot plant to various production facilities. Prepared technical and manufacturing protocols for outside contract manufacturers. Trained technical and production personnel on various projects.
 Successful in pre-formulation, formulation, product development, and process tech transfer of several products. Development Scale-up, range finding, process optimization, and stability studies.
 Prepared, collected, assembled and reviewed chemistry and drug product development documents for sections of ANDAs.
 Interacted with FDA personnel for drug pre-approval, approval, audit and inspection communications. Participant in pre-approval inspections. Provided technical recommendations for FDA responses to Regulatory Affairs.
 Responsible for manufacture of BA/BE (Clinical/Bio) batches for clinical trials, provided all necessary requirements to proper facilities and plants.
 Communicated, coordinated and interacted with Regulatory Affairs, Analytical Development, Stability, Technical Services, Planning, Change Control, Production, Specifications, Packaging, Purchasing, Quality Operation, Material Management, Process Improvement, Statistics, and Pharmaceutical Services, Marketing and Legal Services.
 Selected excipient, equipment and process. Manufactured stability and clinical batches. Wrote batch records, equipment SOPs and technical reports. Reformulated market products and participated in production troubleshooting and problem resolution.

Wyeth-Ayerst Lederle (American Homes Products, Generic Division), Pearl River, New York
Senior Research Scientist (Promoted from Level I to II), 1992-1996

Developed formulation, implementation of projects, developed, communicated knowledge of SOP’s and cGMP’s to the related area and field. Experienced with pharmaceutical manufacturing equipment and procedures, and familiarity with technical manuals and interpretation of results.
Independently designed and executed study plans for pre-formulation and formulation. Developed oral solid dosage forms: capsules, tablets and suspensions. Selected excipient, equipment, processes and new technologies. Manufactured stability, scale-up batches and directed manufacture of clinical batches and validation batches (size: 200 -1000 kg). Generated formulation report and other technical reports. Reviewed analytical data and validation protocols. Prepared documentation for tech transfer. Assisted with pre approval inspection readiness.


SYED AQIL HUSAIN Page 3
Participated in all aspects of planning, scheduling and manufacture of clinical drug products and supportive experimental batches. Performed equipment set up, troubleshooting and cleaning.
 Developed new generic versions of various special branded products with new approach e.g. Modified Release, Special Control Release System developed as #1 product in the pharmaceutical market. Initiated Technology Transfer Processing with latest at drastic cost savings
 Performed Special Research and Development projects, including regular traditional and conventional medications without patent infringement.
Lederle Standard Product, (Division of American Cyanamid) Pearl River, New York
Research Scientist (Promoted from Level I to II), 1987-1992
Independently designed and executed study plans for development of oral solid dosage forms for immediate or modified release in accordance with cGMP. Determined appropriate excipient, equipment, processes, and tooling. Manufactured stability, scale-up, clinical, and validation batches. Wrote formulation/interim formulation reports, batch records, equipment SOPs, Tech transfer documentation, and manufacturing investigation reports (MIR). Process included: direct compression, wet granulation with low/high shear mixer/granulators, fluid bed granulation, fluid bed drying, tray drying, milling, oscillating, screening, compaction, compression, encapsulation, mixing time studies, geometric dilution, and aqueous film-coating. Contracted sample testing; assessed safety and risk of product process.
Developed, evaluated scale-up formulations range and optimization studies, and wrote and reviewed standard operating procedures for various methods and techniques for Validation and Manufacturing Processes. Set up product specifications and process parameters. Initiated Change Control and Make implementation. Managed, provided leadership to multi-discipline project team, ensured new products, processes and equipment are validated according to FDA and cGMP standards. Provided consultation and technical support to all production facilities. Recommended and implemented independent technical solutions resulting in process improvement.
Designed and executed equipment qualification protocols prepared reports and assessments.
Mutual Pharmaceutical. Philadelphia, PA 1986-1987
Administration.
Covering Production, Formulation, Production, and R&D Departments. Responsible for component and supplies to meet production schedules in all production departments.
Danbury Pharmacal (Watson Pharmaceutical) Danbury, Connecticut 1973-1986
Production Scientist/Pharmacist Promoted to various positions)
General Pharmaceutical duties as a production pharmacist, achieved remarkable performance. Products developed for G.D. Searle, Johnson and Johnson, SKF, Lederle, A.G. Schering, and Boehinger Ingelheim Pharmaceutical companies. Previous experience with Liquids, Semi Solids, Ointments, Lotions, and Creams.
Independently designed and executed study plans for the development of oral solid dosage forms, from bench level to clinical batches (100,000 units).
 Developed and formulated as a pioneer for modified/control release/Time Release/ Sustain Release system techniques for the beads, seeds, tablets and capsules.
 Developed and generated various Film, Sugar, and Modified Release Enteric Coating uniquely designed techniques for solid pharmaceuticals.
EDUCATION
M.S, in Applied Pharmaceutical Technology (Industrial Pharmacy). Position Holder College of Pharmacy, Long Island University, New York City, New York. May 2001
B. Pharmacy. Faculty of Pharmacy, University of Karachi.

Know-how and experience:
1707-A; Scotch brook Drive
Philadelphia. PA 19115
Home: (215) 698-7464
Cell: (203) 240 2900
syedaqilhusain@yahoo.com

Pharmaceutical R&D, Clinical, and Production experience with achievement of over 50 ANDAs approved. Professionally thorough with extensive experience in Pharmaceutical R&D, Manufacturing, Production, Process Improvement, Technical Services and Trouble Shooting. An innovative and results oriented Pharmaceutical Scientist with over 30 years experience in R&D, production, technology transfers, and process improvement for new and existing products. Proficient in cGMP. Excellent communication skills, able to work independently and to coordinate multidisciplinary teams.
Delivered outstanding value to life for upgrades in Pharmaceutical world. Possesses a clear vision in achieving Corporate Mission and Values with emphasis on Quality, Integrity, Leadership, Collaboration, and Achievement of Common Goals. Commitment to the team concept and focus groups.

Areas of Expertise
 Development of oral solid dosage forms (tablets, capsules, suspension, solutions) .  Scale-up, Pilot Batches, Production Batches, Technology Transfer, Validation
 Data Evaluation and Technical Reports  Batch Records Preparation
 Fluid bed coating (Sustained Release products, Time Release, and Modified Release)  Clinical Batch Manufacturing, Collaboration with all departments for NDA/AND Submission
 Formulation Development, Protocol design and execution  SOP’s and Manufacturing Investigation Reports. Root Cause Analysis and Provided Solution/Conclusion
 Multivariable Pharmaceutical Problem Solving.  Developed Various Modified Release System

PROFESSIONAL EXPERIENCE AND ACCOMPLISHMENTS
Wyeth International Pharmaceuticals, Rouses Point, New York 2002-2004
Principal Scientist & MIR Lead Investigator,
(Transferred from Wyeth Pearl River NY to Rouses Point NY, Facility in 2002)
Investigated production challenges, identified causes of problems/failures, suggested solutions, wrote protocols for investigations, and wrote reports of investigations.
Created Pharmaceutical Products Manufacturing Investigation Reports. Concluded possible deviation, root causes, identified affected areas. Provided Technical supports and corrective action plans. Developed innovative approaches to solving process related problems.
Reviewed and provide consultation. Recommended development Process and Validation Procedures. Prepared Technical Reports/Protocols. Coordinated production activities with production, tech services, analytical lab and quality operations to ensure monthly targets were met...Initiated/Finalized study on production challenges; identified major agents affecting dissolution of product through series of investigations; employed parallel coordinate plots and regression analysis.
Initiated a protocol for investigative study of aspects of raw materials which can predict dissolution behavior of raw material lot.
SYED AQIL HUSAIN Page 2
Wyeth-Ayerst Pharmaceuticals (American Home Products, Generic Division, ESILederle),
Pearl River, NY
Principal ResearchScientist (Highest Scientific Level Achieved) 1996-2002
Project Achievement: Products developed and achieved ANDAs approval as #1 product in the US Market for consecutive 15 years. Performed/Planned independently R&D, Scale-up and Production in cGMP pilot plant, in USA, Canada and contract manufacturing facilities; managed highly skilled team of scientists in Formulation Development and Technical Services and production operations at different stages of development. Established Standard Operating Procedures for various methods of manufacturing and techniques for the ANDAs products.
 Served as a Lead Scientist in research activities for drug product process development, project manager role in Pharmaceutical Research and Development working with interdisciplinary groups within the company.
 Provided, assisted in technology transfer from pilot plant to various production facilities. Prepared technical and manufacturing protocols for outside contract manufacturers. Trained technical and production personnel on various projects.
 Successful in pre-formulation, formulation, product development, and process tech transfer of several products. Development Scale-up, range finding, process optimization, and stability studies.
 Prepared, collected, assembled and reviewed chemistry and drug product development documents for sections of ANDAs.
 Interacted with FDA personnel for drug pre-approval, approval, audit and inspection communications. Participant in pre-approval inspections. Provided technical recommendations for FDA responses to Regulatory Affairs.
 Responsible for manufacture of BA/BE (Clinical/Bio) batches for clinical trials, provided all necessary requirements to proper facilities and plants.
 Communicated, coordinated and interacted with Regulatory Affairs, Analytical Development, Stability, Technical Services, Planning, Change Control, Production, Specifications, Packaging, Purchasing, Quality Operation, Material Management, Process Improvement, Statistics, and Pharmaceutical Services, Marketing and Legal Services.
 Selected excipient, equipment and process. Manufactured stability and clinical batches. Wrote batch records, equipment SOPs and technical reports. Reformulated market products and participated in production troubleshooting and problem resolution.

Wyeth-Ayerst Lederle (American Homes Products, Generic Division), Pearl River, New York
Senior Research Scientist (Promoted from Level I to II), 1992-1996

Developed formulation, implementation of projects, developed, communicated knowledge of SOP’s and cGMP’s to the related area and field. Experienced with pharmaceutical manufacturing equipment and procedures, and familiarity with technical manuals and interpretation of results.
Independently designed and executed study plans for pre-formulation and formulation. Developed oral solid dosage forms: capsules, tablets and suspensions. Selected excipient, equipment, processes and new technologies. Manufactured stability, scale-up batches and directed manufacture of clinical batches and validation batches (size: 200 -1000 kg). Generated formulation report and other technical reports. Reviewed analytical data and validation protocols. Prepared documentation for tech transfer. Assisted with pre approval inspection readiness.


SYED AQIL HUSAIN Page 3
Participated in all aspects of planning, scheduling and manufacture of clinical drug products and supportive experimental batches. Performed equipment set up, troubleshooting and cleaning.
 Developed new generic versions of various special branded products with new approach e.g. Modified Release, Special Control Release System developed as #1 product in the pharmaceutical market. Initiated Technology Transfer Processing with latest at drastic cost savings
 Performed Special Research and Development projects, including regular traditional and conventional medications without patent infringement.
Lederle Standard Product, (Division of American Cyanamid) Pearl River, New York
Research Scientist (Promoted from Level I to II), 1987-1992
Independently designed and executed study plans for development of oral solid dosage forms for immediate or modified release in accordance with cGMP. Determined appropriate excipient, equipment, processes, and tooling. Manufactured stability, scale-up, clinical, and validation batches. Wrote formulation/interim formulation reports, batch records, equipment SOPs, Tech transfer documentation, and manufacturing investigation reports (MIR). Process included: direct compression, wet granulation with low/high shear mixer/granulators, fluid bed granulation, fluid bed drying, tray drying, milling, oscillating, screening, compaction, compression, encapsulation, mixing time studies, geometric dilution, and aqueous film-coating. Contracted sample testing; assessed safety and risk of product process.
Developed, evaluated scale-up formulations range and optimization studies, and wrote and reviewed standard operating procedures for various methods and techniques for Validation and Manufacturing Processes. Set up product specifications and process parameters. Initiated Change Control and Make implementation. Managed, provided leadership to multi-discipline project team, ensured new products, processes and equipment are validated according to FDA and cGMP standards. Provided consultation and technical support to all production facilities. Recommended and implemented independent technical solutions resulting in process improvement.
Designed and executed equipment qualification protocols prepared reports and assessments.
Mutual Pharmaceutical. Philadelphia, PA 1986-1987
Administration.
Covering Production, Formulation, Production, and R&D Departments. Responsible for component and supplies to meet production schedules in all production departments.
Danbury Pharmacal (Watson Pharmaceutical) Danbury, Connecticut 1973-1986
Production Scientist/Pharmacist Promoted to various positions)
General Pharmaceutical duties as a production pharmacist, achieved remarkable performance. Products developed for G.D. Searle, Johnson and Johnson, SKF, Lederle, A.G. Schering, and Boehinger Ingelheim Pharmaceutical companies. Previous experience with Liquids, Semi Solids, Ointments, Lotions, and Creams.
Independently designed and executed study plans for the development of oral solid dosage forms, from bench level to clinical batches (100,000 units).
 Developed and formulated as a pioneer for modified/control release/Time Release/ Sustain Release system techniques for the beads, seeds, tablets and capsules.
 Developed and generated various Film, Sugar, and Modified Release Enteric Coating uniquely designed techniques for solid pharmaceuticals.
EDUCATION
M.S, in Applied Pharmaceutical Technology (Industrial Pharmacy). Position Holder College of Pharmacy, Long Island University, New York City, New York. May 2001
B. Pharmacy. Faculty of Pharmacy, University of Karachi.

Fields of Consulting work:
Researcher for Pharmaceutical