Project Manager

Mohamed Abdelrahim

Objective: To obtain a process/project development leadership role that

best utilizes my employment and educational experience to their

fullest potential within a challenging and productive

pharmaceutical process environment.

Professional Employment:

2011 - Present Merck & Co. - West Point, PA - Senior Development

Engineer

. Primary role as Lyophilization Tech Lead, consisting of a consulting role

for lyophilization related development activities for all sterile

injectable products that are in the commercialization phase. This role is

also responsible for investigating industry developments in the

lyophilization sphere as well as staying up to date with current

regulatory trends and expectations. In this role, served as Subject

Matter Expert to assist with resolution of various root cause analysis,

lyo cycle development, as well as a host of other activities related to

freeze drying cycle development. Worked within organization to serve as

presenter for lyophilization development considerations during early

development phase for lyo products.

. Responsible for launch of pre-filled syringe image of existing vaccine

(vial image) in Japanese market. Serve as leader of Drug Product Working

Group, which is comprised of several functional role leaders to develop

manufacturing process as well as all required analytical assays for new

product images from pilot scale through commercialization. In this role,

successfully worked with team members to execute several

stability/clinical lots as well as scale up to commercialization and

launch.

. Serve as functional leader for glide force control strategy for new

sterile injectable cartridge image product.

. Serve as leader for lab scale GMP manufacture of multi-valent vaccine

product, which consisted of joint venture product with another

pharmaceutical company, to support CPP being used during formulation.

Also served as formulation/filling subject matter expert for regulatory

filing package associated with product.

. Led/mentored several junior staff members in managerial role to assist

with day to day activities associated with various projects.

. Worked in conjunction with sterile pilot plant to develop a Sterile

Injectable Liquids 101 training series that covered various topics for

best practices associated with sterile manufacturing and commercialization

activities.

2008 - 2011 Auxilium Pharmaceuticals - Horsham, PA - Manager, CMO

Oversight

. Responsible for supporting all secondary manufacturing projects related

to XIAFLEX , including the on-going collaboration with various CMO's for

commercialization of XIAFLEX , evaluation of alternate manufacturers and

assessment of new fill/finish and dosage delivery technologies.

. Responsible for successfully performing a 6X scale up of XIAFLEX at CMO.

Executed and summarized lyophilization boundary studies for lyo process

optimization. Responsible for day to day oversight of manufacturing of

XIAFLEX at CMO facility as well as serving as technical expert for

deviations, investigations, and change control process. Successfully

transferred XIAFLEX manufacturing process to secondary CMO site.

Successfully reduced line losses at CMO facility yielding approximately

$10 MM in savings per year.

. Responsible for supporting regulatory filings for XIAFLEX manufacturing

process. This includes authoring of relevant BLA sections, updating BLA

sections as needed, and serving as technical expert in the fields of

sterile processing, lyophilization, and cold chain management.

. Responsible for providing clinical supplies for alternate indications as

well development of new formulation and lyophilization cycle development

and optimization for new formulation.

2007 - 2008 Sanofi Pasteur - Swiftwater, PA - Manager, Pharmaceutical

Technology

. Responsible for launch of clinical materials for a new injectable vaccine

image (flu vaccine) at a contract manufacturing site. Responsible for

development of technologies to transport material to and from CMO as well

as develop information required for successful product launch.

. Responsible for start up and launch of existing product in a new sterile

filling line located in a new sterile injectable manufacturing facility.

Line launch included filling of sterile injectable liquid product, however

included freeze drying capabilities for future product transfers.

Included oversight of 3 contractors to achieve project objectives.

. Responsible for execution of stability fills for a new product component

image. Involved in Global Quality Directive assessment comparing current

lyophilization practices and also responsible for developing remediation

program to assess any identified gaps. This remediation plan included

updates to existing lyophilizer as well as launch of new lyophilizer.

. Direct responsibilities consisted of development of new processes for

syringe fills of vaccine products, technology transfer (validation,

engineering studies, process development/improvement, scale up) of

existing processes to contract manufacturing sites as well as to internal

facilities.

. Training and oversight of several contract employees to ensure completion

of objectives and key project milestones.

2002 - 2007 Merck & Co. - West Point, PA - Senior Engineer

. Responsible for launch of EMEND IV at contract manufacturing site as

well as transfer of EDECRIN to contract manufacturing site. Responsible

for oversight of project from kickoff with CMO through process validation.

. Implemented $2 MM annual savings to manufacturing process as a result of

line-loss savings on CANCIDAS . Involved in investigation of material that

resulted in savings of $1 MM of product out of $3 MM of product discarded

as part of atypical processing. Implemented usage of potential discard of

material that resulted in $14 MM savings.

. Provided technical support in Sterile Process Technology & Engineering

department to Manufacturing Operations for medically significant products

and sterile injectable vaccines.

. Responsibilities consisted of IQ/OQ/PQ of new lyophilizers, technology

transfer (validation, engineering studies, process

development/improvement, moisture characterization, scale up) of existing

processes to new lyophilization facility.

. Developed and executed protocols for the qualification and validation of

new processes and/or equipment. Responsibilities included knowledge and

application of cGMP's and FDA regulations, application of sterile

processing, updating manufacturing documents, writing of technical process

descriptions for product license submission, validation of new equipment /

processes, project design, design / implementation of experiments,

troubleshooting, scale-up, initiation and follow up of process changes,

and providing technical support for Manufacturing.

. Training and oversight of several contract employees to ensure completion

of objectives and key project milestones.

. Developed and executed protocols and Validation Plans pertaining to

commercialization of new sterile injectable product.

. Responsible for 2X and 3X batch size scale up of CANCIDAS .

1999 - 2002 Melcor Corporation - Trenton, NJ - Project Manager

. Coordinated engineering projects between Design Engineering, Quality

Department, and Production Department in order to tailor custom products

to meet client's specific requirements. Responsible for proposal

preparation, attendance of trade shows, budgeting, forecasting, and

project bidding.

. Extensive experience in design and application of thermoelectric-based

cooling systems for various applications that include HPLC/GC, PCR

cyclers, reagent cooling, blood analysis instrumentation, and cell culture

systems.

. Developed an increase of 80% in sales for market segment and responsible

for maintenance of over $9 million in customer accounts.

. Responsibilities include training, hiring, and supervision of new

Application Engineers.

Education:

2003 - 2006 Lehigh University - Bethlehem, PA

. Master of Engineering degree in Chemical Engineering.

. Concentration on biotechnology.

1994 - 1998 University of Maryland Baltimore County - Catonsville, MD

. Bachelor of Science degree in Biochemical Engineering.

. Senior design project consisted of purification of Factor

VIII from human blood plasma.

1990 - 1994 University of Maryland at Baltimore - Baltimore, MD

. Completed the first four of five years in the Bachelor of

Science degree in Pharmacy.

Honors & Certificates:

EIT Certificate, Honors College Scholarship, Senatorial Scholarship.

Professional Memberships & Relevant Experience:

IVT

PDA

International Society of Lyophilization

Strong technical background in freeze drying cycle development and

troubleshooting. Experience with DOE (design of experiments),

commercialization / product launch, project management with contract

manufacturing sites, statistical techniques to problem solving, validation,

cGMP's, writing of SOP's, experimental analysis, process scale up,

lyophilization, tech transfer, validation, and process streamlining.

Experience with development of manufacture of new sterile injectable

products, including developing/executing protocols, supporting regulatory

filings, developing rationale for validation included in product regulatory

filings, as well as ensuring "seamless" project launch / demonstration

during commercialization of new products.

Miscellaneous: U.S. citizen.

References: Will be furnished upon request.

Contact this candidate