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yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 ~ xxx-xxx-xxxx

 

objective

skilled technical professional seeking mid or senior level position in either a quality assurance or process engineering group within the pharmaceutical industry. participated on cross-functional multi-site technical teams to resolve manufacturing issues. accountable for the success of multifunctional manufacturing teams.

significant accomplishments

-         lead technical representative during fda pai audit that resulted in no 483 observations.

-         conceived and developed a unique fiber optic flowcell for use in performing on-line analysis of aerosol suspensions (us patent awarded).

-         developed a novel in-situ analytical method for the determination of trace level impurities in cryogenic fluids using near-infrared technology (patent pending).

-         salvaged 6000 man-hours required for content uniformity assay of solid dose products.

-         re-couped 2500 man-hours required for aerosol end dose testing.

-         implemented new particle size analysis technology (lasentec) that allowed the continuation of validation efforts for the transfer of jurong sourced fluticasone propionate in flovent mdi.

-         provided novel solutions to the quality assurance department on numerous technical issues to ensure the quality of the product and its timely release to market.

-         conceived a novel device for the measurement of aerosol valve run out (patent pending).

career history

glaxosmithkline, north carolina

senior technical manager, dry powder dose forms, 2007 c present

         accountable for the technical management of the dry powder inhalation (dpi) manufacturing process.

         successfully liaise with external stakeholders to produce innovative technologies for use in manufacturing and testing of dry powder inhalers.

         oversee new product development teams skilled in the secondary manufacturing process(es) for the dry powder inhalation new chemical entities and line extensions into the global manufacturing supply (gms) network.

career highlights

-         skillfully instituted methods of enhancing the methods behind particle size determination of the finish product.

-         secured approval for two novel compounds to move into phase 2b development.

-         championed new technology for use in size reduction of an active ingredient to reduce variability and improve self life performance.

 

section head, process engineering, dry powder inhalation, 2001 c 2007

         directed the consistent success of process engineering group tasked with technical management of dry powder inhalation manufacturing area.

         spearheaded successful completion of regulatory audits.

         assessed quality of batches of manufactured goods.

career highlights

-         customized innovative manufacturing of advair dpi to meet accelerated global supply strategy changes.

-         executed an fda pai audit to approve the zebulon dpi site and advair manufacturing process with no 483 observations.

 

yyyyyy x. yyyyyy ~ page 2 of 2

 

principal process engineer-aerosols/non-solids, 2000 c 2001

         produced metered dosed inhalers and investigated all atypical manufacturing events to determine root causes and implement appropriate corrective actions.

career highlights

-         successfully reduced cost of goods through the implementation of novel sensors to detect and prevent the manufacturing of rejected material.

-         successfully transferred and validated new manufacturing process for flovent inhalers.

-         awarded a patent for the development of a novel method for dimensioning aerosol cans.


senior process engineer-aerosols/non-solids,1999 c 2000

         manufactured metered dose inhalers and supported execution of process improvement projects to maximize batch yields.

career highlights

-         successfully isolated the root cause of an issue that resulted in the worldwide shutdown of ventolin production avoiding a stock-out situation.


principal scientist qc,1998 c 1999

         operated within aerosol process engineering group to investigate the potential for the use of analytical sensors to monitor the manufacturing process.

career highlights

-         developed a near infrared method for the detection of trace level impurities in cryogenic fluids.

-         developed method for the determination of drug concentration in an aerosol slurry solution.

 

****additional experience as group leader-automation/methods development, qa analyst- automation/methods development, associate qa analyst-stability, assistant qa analyst-stability, and us army-north carolina national guard***

 

education

bachelor of science, textile chemistry  

north carolina state university, raleigh, north carolina

 


yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 ~ xxx-xxx-xxxx

 

<date>

 

<<first name>> <<last name>>

<<title>>

<<company>>

<<street address, suite #>>

<<city, state zip code>>

 

dear <<courtesy>> <<last name>>,

 

it is with great confidence that i offer my years of experience as senior technical manager and process engineer to your organization. as i pursue the <<position title>> within <<company name>>, i recognize that my credentials and experience would greatly assist in reaching future goals and objectives.

 

my professional history is the basis for my confidence that i would be a valuable asset to your organization. my career history consists of vast experience in pharmaceutical manufacturing operations. i consistently communicate the project vision to the internal members of the organization so that everyone understands their role in achieving these goals, ensuring that the action steps are taken to ensure that goals are met and developing action plans to achieve those goals. thereafter, i prepare recommendations for improvements, controls, new methods, and other changes to improve the efficiency of operations.

 

during my career, i ve gained notable experience leading and training other employees in the appropriate procedures related to the manufacturing of pharmaceuticals. my professional background also includes a proven expertise in process engineering, operation management, expediting projects, interpreting complex technical information, and effectively communicating with other members of upper management and personnel, verbally and in writing.

 

many of my past positions consist of coordinating operations of a complex, interrelated, and interdependent nature, where unknowns and numerous contingency factors were involved. with this experience, i formulate policies and procedures relevant to daily operational and special programs based on information of a conceptual nature from varied and complex sources. with vast knowledge of the principles and techniques of process engineering in addition to organization, planning, training, and reporting, and a strong background in operations management that i bring to your organization.

 

 

my aptitude for evaluating complex problems and reviewing related information to develop viable solutions would be of great use to your organization. i welcome more discussion about how my skills can help in meeting the goals and objective of your organization. until then, should you have any additional questions feel free to contact me at your convenience.

 

sincerely,

 

 

 

 

 

yyyyyy x. yyyyyy

enclosure

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