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Cell Phone (707) 450 - 6831 - E- Mail ad3cn6@r.postjobfree.com

TEKLE WOLDEMICHAEL

OBJECTIVE

To use my expertise in small and large scale microbial and mammalian cell fermentation, purification or relative fields.

WORK EXPERIENCE

Self Employee, July 2015 - Present

Bayer Berkeley, CA.,

Purification Technician, March 2015 – July 2015

CIP and SIP purification vessels

Pack and unpack purification column

Daily calibrate such as pH, conductivity meters

Collect daily WFI samples

Review batch records

BIOMARIN NOVATO, CA

Specialist, Manufacturing, April 2007 –October 2014

Operate perfusion Bioreactors, size 95L, growing mammalian and microbial cultures.

Prepare media and solutions for the reactors.

Working and knows how to operate UF (Ultra Filtration) system.

Working and knows how to operate titration (pH adjust) system.

Acting as a lead in the absence of the lead.

Trouble shooting and solving problem if something happen to the reactor.

Review Batch records.

knows LIMS system.

BERLEX BIOSCIENCES, Richmond,

Senior Operator, Clinical Production, February 2002 - April 2007

Performed, operate and maintain different sizes purification columns and related equipment.

Wrote and re-wrote CPP’s and BPR’s to achieve the goal of purification scale-up and other producers.

Purified product for Clinical Trials using various techniques and columns sizes - AIEX, SEC,UF/DF, reverse phase.

Prepare buffers and perform final formulation.

Inspected final product vials.

Proficient in the use of Bio-Process Unicorn System.

Proficient in the use of Applicon’s DCU3, ABEC controlling systems.

Assisted/Operated Bioreactors from 3 L to 1000 L, growing mammalian and microbial cultures.

Assisted with validation of facilities and equipment for new Clinical Manufacturing Suite.

Performed mixing studies on new media/buffer tanks, sizes 50 L to 1000 L.

Completed special project such as revamping of the batch record format, change control of equipment, and off site fermentation project support (i.e. Bothell, Seattle).

Assisted Process Development with developing scaling up fermentation from 10 L scale to 1000 L scale.(Mammalian and microbial) and purification processes.

Received two “CITE AWARDS” at different times for excellent performing.

XOMACORPORATION BERKELEY, CA.,

Technician III Fermentation Department March 1999 - February 2002

Performed in cGMP commercial scale of mammalian cell derived therapeutics up to Phase III trials.

Assisted in the recovery and purification of rBPI protein antibody.

As a team member of fermentation, I assisted in the production of 700g of purified drug substance at a very low contamination rate.

Responsible for CIP, SIP and running ABEC Fermenters size 3000L, 500L and 130L.

Responsible for primary and back-up production columns with 100% success rate.

Trained new hire employees.

CHIRON CORPORATION, EMERYVILLE, CA.,

Technician II, Pilot Development Unit (PDU), January 1998 - March 1999

Responsible for running the fermentation and recovery processes for two therapeutic products, Betaseron and Interleukin.

Fermentation process involved setup of media inside a 1000L tank for inoculation.

Recovery processes involved diafiltration, homogenization, butanol extraction and centrifugation.

Experience working in GMP manufacturing facility under cGMP guidelines.

Followed SOP documents in performing manufacturing procedures which also involved double check sign-offs.

Performed proper gowning upon entering GMP designated areas.

Used aseptic techniques such as IPA prep cleaning and proper pipetting when performing sampling procedures inside the lab.

Familiar with the use of a biotest gun for air sampling, and gel surface sampling for QA submission.

Experience working in all three shifts: graveyard, swing, and day.

XOMA CORPORATION, BERKELEY, CA.,

Technician II, Fermentation Department, March 1989 - January 1998

Responsible for large scale-up and production inoculums cell culture production to produce life saving pharmaceuticals under cGMP/GLP condition.

Participated in the start-up of ABEC 3000L, 500L and 130L Fermenters.

Participated with purification operation up to 1- meter diameter columns.

Prepare buffers and perform final formulation.

Performed process validation for determination resin cycle using an automated Camille Systems.

Responsible for all documentation within cell culture unit operations.

Participated in a FDA pre-approval with zero 483s.

Received “AWARD OF MERIT” for scale-up performance.

Trained new hire employees.

TRAINING

NOVA Bioprofile 100 Plus Chemistry, Adv.Op. Training Nova Biomedical, Oct 2006.

IBC’s Training ACADEMY Course on ‘Introduction to Biopharmaceutical Manufacturing, SF, CA., Sep. 2005.

Bioprocess System and Unicorn Software Training, Richmond CA., Jan., 2004.

EDUCATION

Santa Familia University, Asmara Eritrea

Laney College, Oakland, CA., Major Chemistry

COMPUTER SKILLS

Excel, Word, Power point..etc.

LANGUAGE SPOKEN

English, Tigrigna (Eritrean), Amharic (Ethiopian), Arabic, some Italian.

REFERENCES

Furnished upon request.

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