Manager Manufacturing
Resume:
AHMAD RAZA
* **** ****** ******* * senior level managerial position where knowledge,
Road experience, and skill will add further value to company
Oxford, CT 06478 operations.
Tel. (203)
Cell (203)
947-4276
Email:
abof99@r.postjobfree.com
m
SUMMARY . Successful and progressive experience in pharmaceutical
research and development, quality assurance, technical
services/regulatory affairs, and manufacturing. Expertise in
drug formulation, process/product improvement and
optimization, transfer of technology, validation, compliance,
and troubleshooting of manufacturing and formulation problems
of conventional and controlled release drugs.
EXPERIENCE
PAR PHARMACEUTICALS INC., New York
Manager Technical Operations (04/2010 - present)
. Responsible for process development and validation
activities for ANDAs developed both in-
house and via external joint ventures with special emphasis on
technology transfer /batch scale-
up, and product optimization activities from project
initiation through commercial launch.
. Serve as a continuing source of expert-level technical
guidance to manufacturing, regulatory,
quality, lab, and business development departments, with
expert knowledge of product
formulation and development of robust processes involving
wet/dry granulation, compression;
encapsulation; fluid bed drying; high shear mixing;
compaction; coating, etc.
. Perform troubleshooting of manufacturing processes with
regard to equipment-related
and formulation-related problems of all types of solid dosage
products including
conventional, controlled release, and multi-particulate
controlled release drugs.
. Continually review latest manufacturing technologies and
implement product and process
optimization methods leading to manufacturing cost efficiency
while maximizing quality.
. Lead root-cause investigations to identify and rectify
causes of any unexplained batch
discrepancies or failure of any product components to meet
established specifications. .
. Coordinate plant preparations for successful FDA pre and
post approval site inspections
. Conduct cGMP monitoring and training, operational training,
as well as develop and
administer SOPs.
. Assist in coordinating fiscal year budget for department
and budgets for individual
projects, as well as hiring/training staff for the department.
Coach department scientific
professionals and support staff, provide technical expertise
to help complete projects,
and mentor them on supervising their own project groups.
WATSON LABORATORIES INC., New York/Connecticut
Manager of Pharmaceutical Technology (12/1994 - 07/2009)
. Responsible for equipment/systems and processes at Watson's
NY and CT manufacturing
facilities including equipment and process validation,
technology transfer/batch scale-up,
product optimization and cleaning validation activities.
. Perform troubleshooting of manufacturing processes with
regard to both equipment-related
and formulation-related problems with all types of solid
dosage products.
. Lead investigations to identify and rectify causes of any
unexplained batch discrepancies or
failure of any product components to meet established
specifications.
. Coordinate plant preparations for successful FDA pre and
post approval site inspections
. Conduct cGMP monitoring and training, operational training,
as well as develop and
administer SOPs.
. Assist in coordinating fiscal year budget for department
and budgets for individual
projects, as well as hiring/training staff for the department.
Manage and coach department
scientific professionals and support staff, provide technical
expertise to help complete projects,
and mentor them on supervising their own project groups.
* Completed the validation of all product potencies at
Watson's NY manufacturing
facility. Performed batch size scale-up of several products
which provided significant cost
savings and improved efficiency. Achieved site transfer of all
products from Watson's
Miami, FL and Puerto Rico facilities to New York to achieve
manufacturing efficiency.
(Raza pag2 of 3)
LANNETT COMPANY, INC., (Pennsylvania)
Director of Research and Development and Technical Operations
(11/93- 11/94)
. Responsibilities included directly overseeing all
manufacturing operations and product
development / regulatory affairs activities in 125,000 sq foot
facility. Successfully enhanced
product development and production departments. (granulation,
blending, encapsulation,
compression, coating, packaging).
. Conducted formulations development for new generic products
(liquid/solid dosage forms)
with hands-on experiments; directly interacted with FDA for
validation and compliance
purposes.
. Resurrected and reformulated stalled ANDAs, performed
validation, and resolved quality
issues with regard to existing products.
. Liaison with FDA for ANDA submission, prior approval
Supplements, regulatory compliance.
. Coordinated all outsourced manufacturing activities
including site visits, technology transfer,
product troubleshooting and optimization.
. Organized, supervised, and provided guidance for all
equipment and cleaning validation
projects, and monitored analytical research and quality
testing.
* ANDA's filed during this time increased product line by 25%;
all validation issues relating to
existing products and newly-developed products efficiently
completed.
DANBURY PHARMACAL, INC. (Schein Pharmaceuticals), (CT/NY)
Manager of Product Development and Process Improvement
(1/91-11/93)
. Reported to Director of Pharmaceutical R & D,
responsibilities included the following:
. Conducted formulations' development for new generic
products. Company's record number of
ANDA submissions occurred during this tenure.
. Formulated immediate and controlled release solid dosage
drugs (compressed tablets,
coated tablets and capsules) including analytical and clinical
data generation and review, and
trained department scientists in formulation work.
. Selected new and used lab scale equipment to continually
modernize R&D efforts. Provided
technical guidance regarding all new manufacturing equipment
purchases.
. Interacted with regulatory groups and production depts. for
preparation of master formulae
and SOP; manufacture of ANDA/Clinical batches, ANDA
submission; stability monitoring.
. Transferred technology from Product Development to
Production Departments with scale-up.
. Set fiscal year budget for R&D projects, managed/mentored
15+ scientists.
* Streamlined product development efforts by optimizing
manufacture of ANDA batches, and
enhancing transfer of technology to manufacturing departments
by using formulation
techniques for which scale-up was feasible and cost-effective.
Manufacturing Manager (1/86-12/90)
. Reported to Director of Operations, responsibilities
included manufacturing and
packaging of solid dosage products by organizing and running
(3 shifts) manufacturing
departments in terms of personnel as well as available
equipment.
. Scaled up new ANDA's as well as existing product line for
cost containment and efficiency.
. Duties included providing cGMP training, operational
training, developing and administering
SOPs, and developing and enforcing standards.
. Evaluated latest manufacturing technology and equipment so
as to constantly improve
manufacturing systems.
. Developed aqueous film coating technology for the company.
Acquired approval from FDA.
. Established process validation protocols for existing
products as well as ANDA's.
. Established cleaning validation protocols.
. Set fiscal year budget for production departments, and
mentored/coached a staff of 90+
personnel in granulation, compression/encapsulation, coating,
and packaging departments.
* Received company president's special commendation for
designing manufacturing systems for
the company's new state of the art New York facility,
acquiring FDA certification for the plant
including equipment/process/cleaning validation, and bringing
plant online by performing
site transfer of all products from existing Danbury plant to
new facility.
Manufacturing Supervisor (1977-1985)
. Provided day-to-day oversight of all manufacturing
departments.
. Trained and managed staff of 150 production technicians.
. Responsible for writing SOP for productions departments.
EDUCATION
(Raza page 3 of 3)
University of New Haven (Connecticut)
. Master of Business Administration, (2000) with concentration
in Scientific Management
. M.S. Pharmacy (1976)
. B.S. Pharmacy (1974)
. Well-versed in computer software applications such as
Microsoft Office and in using these
applications to create project reports, presentations, and
stylized technical documents.
PUBLICATIONS / . "Strategies for Dynamic Pharmaceutical Research and
PROFESSIONAL Development: An analysis of the
MEMBERSHIP Traditional model and the Progressive model of pharmaceutical
research."
(paper presented June 2002)
. Member of the American Pharmaceutical Association
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