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April 2014

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Subject:
From:
Seongkyu Yoon <[log in to unmask]>
Reply To:
Seongkyu Yoon <[log in to unmask]>
Date:
Wed, 9 Apr 2014 12:41:39 -0400
Content-Type:
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Hi CAST10 members, 

Please circulate this ad to anyone who might be interested in. This is a great opportunity to
implement your training on PCA/PLS in PAT (Process Analytical Technology) area of biotherapeutics
development and production. Please make sure to contact either the FDA staff (not me) or refer to
the attachment.

Cheers,
Seongkyu Yoon
----
University of Massachusetts Lowell,
Chemical Engineering and BMEBT Program
Systems Biology Research Group
Biopharmaceutical Consortium (www.uml.edu/bpqc)

------------------------------
From: Kurt Brorson <[log in to unmask]>
Date: Tue, 8 Apr 2014 20:31:39 +0000
To: Kurt Brorson <[log in to unmask]>
Subject: Post-doc at CDER/FDA for Chem E graduates

Good afternoon,
I am taking the liberty of sending an ad for a post-doc position in the bioprocess lab in the
Division of Monoclonal Antibodies, CDER/FDA. Could you post it on your departmental bulletin
board for graduate students that may looking for a position in the near future?
Thank you in advance,
Kurt Brorson, Ph.D.
Division of Monoclonal Antibodies
Office of Biotech Products
CDER/FDA
Office: Bldg. 64, Rm 1036
Lab: Bldg. 64, Rm. 1029
10903 New Hampshire Ave.
Silver Spring MD 20903
Office tel: 301-796-2193
Lab Tel: 301-796-0046
Fax: 301-796-9817
[log in to unmask]
-------------------
Research opportunity in Bioprocessing

A postdoctoral research fellowship in CDER/FDAs White Oak Campus is currently available to join
a team studying the feasibility of PAT in bioprocessing with the specific aim of better controlling
antibody critical quality attributes (CQAs). Conventional biopharmaceutical cell culture involves
multiple input factors, such as media type and feed strategy, cell state, and bioreactor engineering
settings, all of which can contribute to protein product variability, for example in glycoforms
profile. Process Analytical Technology (PAT) is an approach to improving product consistency by
introducing real time monitoring and control of product quality. The lab environment has state of
the art instrumentation in lab&#8208;scale protein production bioreactor cell culture, preparative scale
chromatography and advanced analytical instrumentation. This team&#8208;based project has the
potential to lead to improvements in how the stability, potency, safety, and efficacy of
biotechnology&#8208;derived biologic drugs are achieved.

A Ph.D. degree and experience in biochemistry, microbiology, chemical engineering or molecular
biology are required. An excellent record of oral and written English skills is also required.
Research experience with bioprocessing, bioreactor cell culture, or chromatographic protein
separation is preferred. The position is administered by ORISE. ORISE fellowships are for one year,
renewable based on performance. The successful candidate will join a dynamic and highly
motivated team of scientists.

Salary is commensurate with education and experience. US citizenship, green card, EAD, OPT or
CPT is required. An H1 or J1 visa cannot be sponsored for this position.

To apply:
Please email your CV, a brief description of your research interest, and the contact information for
three references to:

Kurt Brorson, Ph.D.
Division of Monoclonal Antibodies
Office of Biotechnology Products
Center for Drug Evaluation and Research
Food and Drug Administration
Bldg 64, Rm 1036
10903 New Hampshire Ave
Silver Spring, MD 20903
E&#8208;mail: [log in to unmask]
The FDA is an Equal Opportunity Employer.

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