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yyyyyy x. yyyyyy                                             p.o. box 0000 xxxxxx xxxx , xxxx , xxxxx 00000

                                                                                                               (xxx-xxx-xxxx,  abc@xyz.com

objective

results-driven leader eager to contribute strong operations, management, manufacturing, laboratory, technical and communications skills toward actively supporting the employer in optimizing operational performance.

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career profile

ø  b.s., management/accounting, life sciences minor.

ø  11 years of successful background in the biotech/pharmaceutical sector.

ø  record of progression to assignments of increasing authority and responsibility.

ø  expertise in cell-based assays done in qc/gmp environment.

ø  adept in use of automated/semi-automated laboratory equipment.

ø  skilled in clean room gowning procedures and aseptic practices.

ø  knowledgeable in identification/resolution of manufacturing issues.

ø  consistent achievement of stringent project/production deadlines.

ø  well-organized multi-tasker with strong detail orientation.

ø  proficient in advanced business software applications.

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professional experience

cell genesys inc., hayward, ca                                                                                                 2008 - present

qc analyst

       retained to conduct analysis of in-process buffers/media and final products/samples from manufacturing.

       perform assays following sops and deliver peer review of fellow qc analysts.

       effectively document gmp results while tasked with equipment monitoring and maintenance.

amgen, inc., fremont, ca                                                                                                              2005 - 2007

qc analyst

       managed continuous culture of cell lines used in bioassays for potency lot release/stability testing.

       initiated new tissue culture, cell passaging, tissue culture media preparation and viable cell counts.

       prepared reagents and media, administered reagent qualification and performed reagent stability testing.

       procured laboratory supplies to support testing needs.

       assumed responsibility for training of new employees in tissue culture processes.

medimmune vaccines, inc., santa clara, ca                                                                                   2002 - 2005

qc analyst (2002-2005)/environmental monitoring (2004-2005)

       conducted environmental monitoring for cgmp manufacturing facility covering viable air, viable surface, nonviable particulate air and high purity water systems.

       utilized bioburden testing with membrane filtration method.

       responsible for conductivity testing, microbial identification, assay method and support validation.

       verified/evaluated test results including data entry in emss.

bioassay (2002-2004)

       retained to perform release testing of bulk, intermediates and final product using cell culture and virology method.

       supported qc investigations, method validation and stability studies.

       maintained/calibrated lab equipment to ensure gmp compliance.

       monitored and assessed logbooks and temperature chart recorder papers utilizing sops.

       originated data summaries including data entry in lims.

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earlier background

prior to 2002, served as manufacturing associate for incyte genomics, fremont, ca, and aiza corporation, mountain view, ca.  in these assignments, built outstanding robotic, dna chip manufacturing, equipment set-up, cgmp and culture media/buffer/solutions abilities.

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education

san jose state university, san jose, ca, b.s., management/accounting, life science minor
yyyyyy x. yyyyyy                                             p.o. box 0000 xxxxxx xxxx , xxxx , xxxxx 00000

                                                                                                               (xxx-xxx-xxxx,  abc@xyz.com

---

 

 

 

cover letter text

 

date

 

 

 

hiring agent name

title

company name

address

city, state   zip code

 

dear                   :

 

i am currently seeking a challenging career opportunity in a manufacturing/operations supervision capacity and am submitting my resume for your review.  in advance, i thank you for your time and consideration.

 

as demonstrated in the accompanying resume, my professional qualifications include a b.s., management/accounting, life science minor and over 11 years of biotech/pharmaceutical manufacturing background. to complement this background, i possess demonstrated expertise in qc/gmp, cell-based assays, buffers/media, testing/sampling and procurement/maintenance of advanced laboratory equipment as well as strong analytical, problem-solving and managerial capabilities.  as an employee, you will find me to be an enthusiastic and disciplined team player, committed to supporting you in achieving your objectives through superior performance. 

 

i am confident that i could be a valuable asset to your firm, and look forward to interviewing with you in the near future to further discuss my areas of experience and expertise that would be a contribution to your organization.

 

 

 

 

sincerely,

 

 

yyyyyy x. yyyyyy

 

 

 

 

 

attachment

 

 

 

 

 

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