The Golden LEAF Biomanufacturing Training and Eduation Center (BTEC)

Development Assoc Scientist 6092

2009-07-07T16:37:00.001-04:00

JOB DESCRIPTION

Position Title:	Development Associate Scientist Purification/Characterization
Department:	Development
Location:
Position Reports to:	Development Scientist I
Classification:	Radford 6092 Chart C Level 2

OVERVIEW

The Development Associate Scientist Purification/Characterezation will be required to produce and purify RNA to support the development team’s needs. In addition, the associate will help develop and expand our current RNA characterization techniques and procedures as well as develop and optimize alternative RNA production and purification methods.

In addition to the RNA activities, some protein purification, characterization and assay development will be required.

RESPONSIBILITIES

The primary responsibility for this position will be the production of RNA by in-vitro transcription reactions and its purification by HPLC.
Additional responsibilities are:
RNA in-vitro transcription reaction optimization.
RNA purification development and optimization.
Support RNA characterization initiative.
Support pilot lot activities as required.
Purification and characterization of proteins to be used in IFA and ELISA assays
Maintenance of database.
Write and review SOPs and STMs as needed as well writing lab summary reports.

SUPERVISION

Normally receives no instructions on routine work, general instructions on new assignments.

MINIMUM QUALIFICATIONS

Biological Science degree BS+4, MS+2 years of experience with nucleic acid purification/characterization required.
Practical protein purification method development is a plus.
Biological assay development is a plus.
Good understanding of cGMP/GLP is needed.
Good aseptic technique.
Familiarity with experiment design will be welcome.

Excellent analytical and organizational skills.
Strong verbal and written communication skills.
Must be detail-oriented.

Employee Name:
Hire Date:
Reports to:

Page 1 of 2

This outline does not list all the duties of this job. Management reserves the right to revise the job description at any time. This description is not a contract for employment.

Dev Engineer

2009-06-11T11:09:00.001-04:00

Job Posting

We have a current opening for the following position. If you are interesting in being considered for this position, please contact Denise Kilpatrick or Andrew Graham.

Position: Development Engineer I

Reporting to: Senior Development Engineer

Division: Process Development

Date: November 19th, 2008

Basic Functions:

Design, conduct, and analyze experiments in support of process development activities aimed to implement, optimize, or scale-up the manufacture of viral vector vaccines.

Principal Accountabilities:

Evaluate and develop methodologies for viral replicon particles (VRP) purification including, but not limited to filtration and chromatography processes.
Design, test, and implement strategies for aseptic cell harvesting, washing and concentration.
Optimize and implement electroporation techniques and equipment for cell transfection.
Develop VRP harvest protocols using filtration.
Support scale-up activities.
Collaborate in the production of VRP in support of development activities.
Support pilot lot and manufacturing activities as well as the transfer of large scale processes into manufacturing.
Contribute to process qualification and validation.

QUALIFICATIONS:

BS in Chemical Engineering, Biochemical Engineering, or related field.
BS+4 or MS+2 years of related industrial cGMP manufacturing or research development experience.
An understanding of the basics of molecular biology, tissue culture, and purification methods is essential.
Process validation and scale-up experience necessary.
A thorough understanding of a cGMP environment is essential.
The ideal candidate will have filtration and fluid mechanics experience in a vaccine or protein environment as well as a thorough understanding of biopharmaceutical purification processes.
Experience with cell culture techniques, bioreactor operation, cell harvesting, and centrifugation systems is desirable.
The candidate must have a thorough understanding of aseptic techniques and CIP/SIP operations.
Basic understanding of statistics and experimental design is a plus.
Good documentation practices and communication skills are of the outmost importance.

NC EM Save the Date

2009-05-18T10:15:00.001-04:00

2009-05-05T15:25:00.003-04:00

The Biomanufacturing Training and Education Center (BTEC) Summer Program begins June 2009
	The biomanufacturing industry grows and changes rapidly from year to year, creating significant educational demands on our workforce. BTEC is committed to providing updated, cutting-edge education to industry workers ready to take advantage of new industry developments. BTEC's 2009 Summer Program begins in June. Register now to ensure your place at this unique educational opportunity!
June 16—18, 2009 Downstream Biopharmaceutical Process Development This course provides the basic information, lab exercises, and the hands-on experience you need to fully understand and develop the steps essential to downstream biopharmaceutical processes including homogenization, centrifugation, filtration, and chromatography. Read more.
June 23—25, 2009 Bioreactors for Cell Culture Learn about recent trends in bioreactor technology, and gain fundamental understanding of bioreactor technology used in production of therapeutic proteins and vaccines. Get hands-on experience with single-use bioreactors and process analytical technology. Read more.
June 30—July 1, 2009 Biologic Formulation Science Fundamentals Learn the colloidal and macromolecular physical science concepts that underlie protein-protein interactions, protein precipitation, protein crystallization and biologic formulation. Read more.
July 7—July 9, 2009 cGMP Fermentation Operations Apply microbial fermentation techniques at production scale and evaluate the inherent issues resulting from the integration of microbial fermentation unit operations, scale-up/production, and current Good Manufacturing Practice (cGMP) compliance. Engage in lab experiences in a simulated commercial cGMP facility. Read more.
July 14—July 16, 2009 Single-Use Bioreactor (SUB) Technology Gain fundamental understanding of bioreactor technology used in production of therapeutic proteins (monoclonal antibodies, enzymes, growth hormones) and vaccines by large-scale animal cell culture. Read more.
July 21—July 23, 2009 Fermentation Engineering Learn fermentation principles of growing recombinant microorganisms in a bioreactor to express therapeutic proteins. Engage in hands-on lab experiences that define and explore the critical control parameters required to achieve a robust fermentation process. Read more.
Please note: All classes listed above will be held at BTEC on NC State University's Centennial Campus The Golden LEAF Biomanufacturing Training and Education Center (BTEC), on North Carolina State University’s Centennial Campus, provides a wide variety of high-quality educational and training opportunities to develop skilled professionals for the biomanufacturing industry, thus contributing to the social and economic well being of the industry and state. BTEC is an international leader in education and training in biomanufacturing and bioprocessing, involving simulated-cGMP production of high-value biomolecules using cell growth and expression, recovery and purification processes.

Metabolon Seminar FLYER

2009-04-28T09:16:00.001-04:00

BTEC
Seminar

Metabolic
Profiling for Optimization of the Microbial and Mammalian Systems
Used in Biologics Production

Kirk Beebe, PhD

Scientific
Project Leader

Metabolon,
Inc.

800
Capitola Dr. Suite 1

Durham,
NC 27713, USA

Abstract:

Unbiased
global metabolic profiling is an approach for obtaining insight into
the metabolism of a population of cells in a culture environment. As
such, it has had particular utility in the area of upstream
bioprocess optimization of biopharmaceuticals. The hundreds of
metabolites detected by global profiling offer a vastly expanded
panel of biochemicals for monitoring media formulations for
unexpected nutrient depletion or toxicant accumulation. Further,
this panel has yielded detailed insight into why such metabolites
diminish or accumulate. Finally, metabolites that directly impact key
areas of phenotypic output such as stability of the transgene,
glycosylation, and cell viability are often identified by distinct
media formulations by metabolomics.

Speaker
Bio:

Kirk
received his Ph.D. in biochemistry from Ohio State University.
Following this, he was a postodoctoral scientist and senior research
associate at the Scripps Research Institute where he uncovered
connections between protein translational fidelity and
neurodegenerative diseases. He began his career as a purification
process development scientist at Talecris Biotherapeutics where he
gained an appreciation for the challenges of upstream process
development.

When:
Friday, May 1, 2009

Where:
119 BTEC (850 Oval Drive – Centennial Campus)

Time: 1:00
– 2:00P

Next week Wednesday & Thursday......

2009-04-08T09:11:00.002-04:00

Risk-Based Approaches to

Validation
April 15 & 16, 8am-5pm; 1.6 CEU

An effective tool for reducing the cost of validation while ensuring product
quality and patient safety.

Risk-Based Approaches to validation

help many Life Science industries reduce the cost of validation and reduce
time-to-market of innovative products, while ensuring product quality and
patient safety. The course reviews
risk-based approaches as defined by industry and regulatory organizations, their
use and application, as well as points to consider to ensure a successful, safe
and compliant outcome.

Attendance
suggested for Quality Assurance, Regulatory
Affairs, Engineering, IT, Manufacturing, Validation, Process Development
Scientists, and Business Professionals, as well as Life Science Contractors and
service providers.
A general understanding of validation concepts and terminology is helpful
for students prior to taking this course. 16 hrs (two days)

Instructor: David Grote Course No. 35437 $495

Location: NCSU Centennial Campus Biomanufacturing
Training & Education Center (BTEC), Room 124

To register: www.ncbionetwork.org click “Validation Academy” and “Course Registration”

Karin Cleary

Validation Academy

(phone) 919.515.0228

(fax) 919.515.0168

http://www.ncbionetwork.org/index.cfm?dir=validationAcadamy/validation.cfm

North Carolina Community College System BioNetwork: Creating Success in

Life Sciences!

Clean and Green Seminar Registration

2009-03-25T09:26:00.002-04:00

Clearn and Green

Monday 4/13/09

2:30-6pm

Sheraton Imperial Hotel & Convention Center

First 10 students are Free

For more information and registration

2009-03-23T14:29:00.003-04:00

There are now five established Centers of Innovation in North Carolina. COIs accelerate commercialization in specific sectors of the life sciences and create new businesses and jobs across the state. Click here to learn more about the Biotechnology Center's unique funding program.

2009-03-12T09:10:00.004-04:00

ISPE NCSU Student Chapter

3rd Meeting Schedule:

Thursday, March 19th, 2009 @ BTEC RM119

(btec.ncsu.edu – on Centennial next to EB2)

6:30-7:00:  Dinner and Networking

  7:00-7:30: Presentation by Joel Youngblood, Talecris Biotherapeutics, Inc.

     §  Brief overview about Talecris: Plasma Products

§  What is a supply chain: Biotech and Business Interaction

Contact Info:

Email Derek Gallo at drgallo@ncsu.edu

 Visit Our Website: http://students.engr.ncsu.edu/ispe/

 Visit Our Facebook Group: ISPE – NCSU Chapter

All majors are welcome!

We want everyone who is interested or wants to learn more about the pharmaceutical, biopharmaceutical & biomanufacturing industries.

ACBJ study finds Raleigh among few markets to add jobs in 4Q

2009-03-11T14:06:00.003-04:00

Count the Raleigh-Cary market among a small group of Metropolitan Statistical Areas that added jobs in the fourth quarter of 2008, says a study released

The number of jobs in the Raleigh-Cary MSA, which comprises Wake, Johnston and Franklin counties, increased by 3,500 from the fourth quarter of 2007, according to a bizjournals analysis of U.S. Bureau of Labor Statisticsdata. Bizjournals is part of American City Business Journals, the parent company of Triangle Business Journal.

Raleigh’s total of 434,100 jobs in the fourth quarter of 2008 gave the MSA a 0.8 percent gain year-over-year and a 21.6 pecent gain (77,000) jobs since 2003.

The Durham MSA was not among the 100 markets studied by bizjournals. Of those markets, only 17 posted year-over-year job increases in the fourth quarter.

Greensboro joined Raleigh in that select group. The Greensboro metro, which does not include nearby Winston-Salem, had 331,700 jobs in the fourth quarter, up 600 jobs in a year.

Charlotte, which has been hammered by the banking industry crisis, was not so fortunate. The Queen City lost 8,200 jobs over the 12-month period that ended in the fourth quarter of 2008.

Still, Charlotte’s plight pales in comparison to that of Dayton, Ohio, where the job base has been eroding for most of the decade.

DISMAL DAYS IN DAYTON

Dayton added 3,600 jobs in the fourth quarter of 2000, when compared to the same quarter in the previous year. That was its last increase. The subsequent 32 quarters have all resulted in job losses – eight years of slow but steady declines.

Dayton’s streak is by far the worst in the nation, the bizjournals study found. No other U.S. market has amassed a losing streak of more than 13 quarters, and only five markets besides Dayton have been declining for more than eight straight quarters.

The worst employment streaks are concentrated in two areas -- the industrial belt of the Midwest, where the problems bedeviling domestic automakers are now harming most businesses, and Florida, where the collapse of the real estate market has triggered an especially deep recession.

Behind Dayton on the streak list are Detroit, which has lost jobs in 13 straight quarters, and Toledo, Ohio, which has experienced 10 consecutive quarterly losses.

Then come Cleveland and two Florida markets — Daytona Beach and Palm Bay-Melbourne — with negative streaks of nine quarters.

Bizjournals averaged 10 years of monthly employment data to generate quarterly job totals for the nation’s 100 biggest markets. It then compared each quarter with the corresponding quarter a year earlier to determine whether the local job base was growing or shrinking.

Texas is the state that has resisted the recession most successfully to this point. Houston added 43,400 jobs between the fourth quarters of 2007 and 2008, the biggest upswing in the nation.

The two other markets to add at least 10,000 jobs during the past year are also in Texas: Dallas-Fort Worth (up 32,700 jobs) and San Antonio (up 11,500).

The following is a rundown of the three North Carolina metros among the nation’s 100 biggest labor markets, with the job figures for the fourth quarter of 2008 for each, followed by the length of its current quarterly streak of job losses and its one- and five-year records of job growth. To see the full list, go to this story and scroll toward the bottom of the page.

Raleigh

• Jobs (fourth quarter 2008): 434,100
• Consecutive quarterly job losses: 0
• One-year record (‘07-08): Up 3,500 jobs (0.8%)
• Five-year record (‘03-08): Up 77,000 jobs (21.6%)

Charlotte

• Jobs (fourth quarter 2008): 756,400
• Consecutive quarterly job losses: 1
• One-year record (‘07-08): Down 8,200 jobs (-1.1%)
• Five-year record (‘03-08): Up 84,500 jobs (12.6%)

Greensboro

• Jobs (fourth quarter 2008): 331,700
• Consecutive quarterly job losses: 0
• One-year record (‘07-08): Up 600 jobs (0.2%)
• Five-year record (‘03-08): Up 20,800 jobs (6.7%)

Drug R&D spending surges in sinking economy

2009-03-11T13:55:00.000-04:00

The U.S. economy may have fallen off a cliff last year, but drug R&D spending continued to surge upwards. A new survey on R&D reveals that research spending by U.S. biopharma companies jumped to $65.2 billion last year, an increase of $2 billion over the year before, according to analysis by Burrill & Co. and PhRMA.

PhRMA put its usual spin on the economic development numbers, citing the jobs and investments devoted to the search for a cure to what ails us. In a separate study, PhRMA found 686,000 direct employees of the sector engaged in life, physical or social sciences research in 2006.

"Our research indicates that the biopharmaceutical sector has made a substantial contribution to U.S. economic growth, and that on average, this sector contributed more to GDP on a per employee basis and grew faster than the rest of the economy from 1996 to 2006," said Michael Eckstut of Archstone Consulting.

2009 ISPE Poster Competition

2009-02-28T14:23:00.003-05:00

ATTENTION ALL CASA STUDENTS!

The CASA Annual Local Poster Competition is just around the corner.

Please read the following document completely. Advisors and officers, please pass this along to all your student members. This is also a great way to recruit new members if a student wants to participate in the competition. You MUST be an ISPE member at the time of the Poster Competition in order to participate.

CASA’s Student Activity Committee will host the annual Poster Competition Friday March 20, 2009 at the NC State BTEC building. This event will happen during the intermission of the 2009 joint BTEC/ISPE Career Fair. An exact time will be given as soon as it is determined. It will be around the 3-5 timeframe. All the information you need is below in this email. It is also all available on the www.ispe.org website. It is in the Campus Connection link.

ABSTRACTS are due to jclark@yonkersindustries.com by Thursday March 12, 2009. If you have questions, please feel free to email me if you cannot find your answer on the website. A link to previous poster winner abstracts is on page 3 of this email.

If you are an advisor and would like to judge, please contact Marcelo Anderson at marcelo_anderson@ncsu.edu. He will be in charge of recruiting our judging teams this year.

The judging evaluation form is also in this document. PLEASE review it and practice your presentation so you can get the maximum points available. PLEASE make sure your poster meets ALL of the requirements for size, font, etc so you will not get points deducted.

This year the undergraduate and graduate winner will win an all expense paid trip to the 2009 ISPE Annual Meeting located in San Diego, CA.

Who can attend competition: We encourage all students and professionals to come out and see the posters on display whether you are competing in the competition or not.

What is the Student Poster Presentation?

http://www.ispe.org/cs/students_section/poster_competition

The Student Poster Competition is an annual contest held before 30 June by local ISPE Chapters and Affiliates. Local winners advance to the International Student Poster Competition at the ISPE Annual Meeting. Both the final graduate student winner and undergraduate student winner of the international competition receive cash awards, and are have the opportunity to publish their materials in ISPE's magazine Pharmaceutical Engineering, as well as other Chapter/Affiliate publications.

The poster presentation consists of a visual display of research or program highlights on a foamcore poster background, combined with an interactive question and answer period.

Posters include the following:

Title of the presentation
Names of author(s) and affiliated organization(s)
Project abstract (brief summary of project objective, methods, results, and conclusions)
Background Information
Project objectives
Materials and Methods
Results and Conclusions

A poster presentation is an exhibit, not a book. The readers and judges do not expect a lot of detail. Graphics work very well and should be used to convey project information where possible.

It is your faculty and industry advisors job to ensure your ISPE membership is up to date as of 3-20-09.

Local Winners Advance

All Student Members who have competed in a local Student Poster Competition may participate in the International Student Poster Competition at the ISPE Annual Meeting, to be held this year from 8-11 November, 2009 in San Diego, California. Chapters/Affiliates are only obligated to support two student winners (graduate and undergraduate) but they may choose to support others. The students may obtain other support to attend from their schools, fund raisers, parents, and earnings. They may NOT solicit funds from companies but may accept donations if they are offered. Students should seek advice from their Faculty and Industry Advisors.

Students must be ISPE Student Members BEFORE competing in the local Student Poster Competition.

If you are uncertain about a student's status, please contact Tracey Ryan for verification by email at tryan@ispe.org or by telephone to 813.960.2105 Ext. 279

If the students win and then graduate, they may still compete at Annual Meeting in the fall.

Poster Competition Guidelines

1. Each contestant must be a registered eligible ISPE Student Member PRIOR to competing at the Chapter/Affiliate poster competition. Note: Post docs are not considered students.

2. Only ISPE Student Members who have competed at the Chapter/Affiliate competition are eligible to compete at the international competition at Annual Meeting.

3. Contestants shall present a project related to research and development, facilities, and business operations and of interest to the pharmaceutical, biotech, and/or medical device industries. ISPE consists of industry professionals and academic leaders focused in the areas of facility design, engineering, human resources, process development, sales, computers, regulatory compliance, manufacturing, the environment, technology, and research and development. Poster topics may relate to any of these facets of ISPE. (For help with topic selection, contact the Faculty or Industry Advisor for your Student Chapter.)

4. Contestants shall develop panel sections for the project abstract, background information, materials and methods, graphics, charts, summary, etc. Sections may be mounted on color matboard for additional contrast and visual appeal. Contestants may choose to plot the entire poster on a 40"x60" sheet. This approach is acceptable providing contestants maintain proper section size and separation within the continuous sheet.

5. ISPE (at the local and international levels) will supply each contestant with a white 40"x60" foamcore poster board and easel at the competition. Contestants may choose to orient the poster board vertically or horizontally for the competition. Sections shall be affixed to the white 40"x60" foamcore poster using Velcro tape or pushpins supplied by ISPE at the competition. Posters plotted as a continuous sheet must fit within the borders of the foamcore poster board.

6. Poster shall be fully assembled with all text, photos, charts, drawings, and/or illustrations completely formatted and ready for viewing one hour prior to the start time of the poster competition.

7. Illustrations must be readable from a distance of 3 feet.

8. No commercial advertisements or logos are permitted. University and Chapter logos may be used.

9. Collaborative poster presentations are acceptable; however, only one primary author is permitted to compete. Substitutions will be allowed for the international competition only if the substitute is an ISPE Student Member and a member of the original research team. The substitute's name must be on the original abstract and poster.

10. Other researchers must be acknowledged on the poster. Since there is an opportunity to publish the poster in future ISPE publications, collaborative researchers must agree to allow the presenter to publish the contents of the poster in his/her name, with other researchers being acknowledged in the publication.

It is the responsibility of the Industry Advisor to ensure the poster is the work of the Student Member presenting. If the poster is a collaborative effort all researchers must be acknowledged. It is also the responsibility of the Faculty Advisor and the Industry Advisor to ensure all Poster Competition guidelines are followed.

11. Contestants will be given a ten-minute window to showcase their projects with the judges. Judging sessions will consist of a five-minute presentation given by each student plus a five-minute question-and-answer period.

12. Contestants may not change or update their poster presentations between the local Student Poster Competition and the International Student Poster Competition. What is presented at the local level is what may be presented at the international level.

13. Contestants will add to their poster the completion date of their research.

Judging

Judges for Chapter/Affiliate competitions will be leading local industry professionals selected by each Chapter/Affiliate. (Chapters/Affiliates are encouraged to hold their competitions before before 30 June 2009, given that registration for the Annual Meeting begins in August.) Judges for the international competition will be active ISPE members. Contestants will be given a ten-minute window to showcase their projects with the judges. Judging sessions will consist of a five-minute presentation given by each student plus a five-minute question-and-answer period. View the Poster Evaluation Form to understand the judging criteria. Students should keep in mind the diverse backgrounds of the judges when developing their poster and presentation.

Post-Judging

Chapter/Affiliate Competition: Event structure may vary from Chapter to Chapter. Contestants shall plan on discussing their poster with other Chapter members present at the event. The winners of the graduate and undergraduate competitions will be decided at the event and will each receive a trip to the ISPE Annual Meeting to compete at the international level.

Annual Meeting Competition: After the completion of judging, the posters will be displayed for the attendees to view. Contestants shall remain with their posters for the duration of the session, as indicated in the technical program of the event, or as directed by the manager of the event on-site. Contestants are responsible for disassembly and removal of the poster following the session. ISPE cannot assume responsibility for materials left beyond those time limits. The international winners will be announced at the ISPE Membership Luncheon during the Annual Meeting. Each winner receives a cash award.

For More Information

Contact the Faculty or Industry Advisor for your Student Chapter. If you do not belong to a Student Chapter or there is not one in your area, contact Lynne Richards, Director of Affiliate and Chapter Relations at tel: +1-813-960-2105.

Previous Winners Abstracts

http://www.ispe.org/cs/students_section/poster_competition_abstracts_2008

Poster Evaluation Form

Directions

This form contains items that are arranged in three subcategories. The subcategories focus on: (A) overall appearance, (B) content, and (C) presentation. To systematically evaluate a poster, circle the number that best describes the degree to which each item fits the poster. The rating scale ranges from 1 to 5 (5 = very good, 4 = good, 3 = passable, 2 = poor, 1 = absent). In appraising a poster, give only one rating to each criterion. If you rate an item “3” or less, include a comment to summarize your observations about that criterion. Also, include remarks about the strengths of the display.

After you have evaluated each item, tally those in each category to obtain the sub-score. Then, add the three sub-scores to obtain the total score. Finally, consider your numerical ratings, as well as your written comments, and compile a summary statement highlighting the strengths and limitations of the poster.

General Information

Title of Poster Presentation:

Presenter’s Name:	Judge’s Name:
Date:	Total Score:

Criteria Rating & Comments

Category A: Overall Appearance (20%)

Does the display attract the attention of the viewers? 1 2 3 4 5
Is the display free of unnecessary detail? 1 2 3 4 5
Is there appropriate use of white space to avoid crowding? 1 2 3 4 5
Is the script visible from three feet? 1 2 3 4 5

Sub-score A _____________

Category B: Content (50%)

1. Is the title clearly stated to include the variables that were investigated? 1 2 3 4 5

2. Is the time period that this research covers shown on the poster? 1 2 3 4 5

3. Is the content presented in a logical manner? 1 2 3 4 5

4. Is the content clear and easy to understand? 1 2 3 4 5

5. Is the information relevant to the pharmaceutical industry? 1 2 3 4 5

6. Is the purpose stated? 1 2 3 4 5

7. Is the method succinctly described? 1 2 3 4 5

8. Do the data/graphics clearly convey the intended data? 1 2 3 4 5

9. Are the results presented in such a way so they make sense to the reader? 1 2 3 4 5

10. Are possible future research or industry applications presented? 1 2 3 4 5

Sub-score B _____________

Category C: Presentation (30%)

Rate the author’s ability to present content in a logical, continuous manner. 1 2 3 4 5
Rate the flow of the author's answers (i.e. choppy, "ums", rambling). 1 2 3 4 5
How knowledgeable was the author on the subject matter? 1 2 3 4 5
Rate the professional presence of the author. 1 2 3 4 5
Rate the author's body language (i.e. nervous twitching, avoids eye contact). 1 2 3 4 5
Rate the author's enthusiasm for project and the presentation. 1 2 3 4 5

Sub-score C _____________

Total score _____________

Summary Comments

Strengths: ____________________________________________________________________________________

______________________________________________________________________________________________

Weaknesses:___________________________________________________________________________________

______________________________________________________________________________________________

From Discovery to Fill and Finish

2009-02-28T13:53:00.002-05:00

ISPE Webinar-Regulatory Affairs

2009-02-16T09:44:00.000-05:00

Negotiating the Regulatory Minefield for Multi-product Facilities:
Helping CMOs and Generic Manufacturers Avoid Warning Letters, Recalls and Worse

Webinar broadcast live at two times on 24 February: 08.00 EST and 11.00 EST
Duration: 90 Minutes, Level: Intermediate

Online Registration

Led by Steven Ostrove, PhD, President, Ostrove Associates, Inc. (Industry Representative for the FDA’s Allergenic Products Advisory Committee from 2005 to 2007), and Julian Wilkins, Vice President, PharmaConsult US Inc., this live webinar identifies elements that should be in a specialized plan for securing regulatory approval in a multi-product facility, provides understanding for all processes involved and how to effectively manage risk and change control in this specialized environment.

It also examines common risks, suggests concrete methods for approaching risk management in a logical and defensible manner, and helps you understand the most frequent areas of regulatory concern, and how to respond to a warning letter. There is real benefit in conducting informal pre-approval discussions.

Registrants will be able to submit questions ahead of time; submit questions to cgarcia@ispe.org.

Attendance Recommended For
Professionals from quality, regulatory, validation, operational management, and engineering.

ISPE Online Learning
Live webinars are one of the many new Online Learning programs ISPE continues to add to its family of educational products. Web-based products include: live and recorded Webinars on critical industry and regulatory developments, recorded GMP online courses, Certified Pharmaceutical Industry Professional^TM (CPIP^TM) online courses, podcasts, live speaker webcasts from ISPE conferences, and post-event video recordings from ISPE conferences. More Information

Targeted advertising and sponsorship opportunities available for ISPE Live Webinars. Contact Dave Hall at tel: +1-813-739-2274, or Valerie Adams, tel: +1-813-960-2105, Ext. 212.

ISPE_Poster_Competition_2009

2009-02-03T14:38:00.001-05:00

Dear
Students,

ISPE has an annual
poster competition and the winner from the local event receives an
all expenses paid trip to the ISPE Annual Meeting – Held in San
Diego, CA from 11/8/09-11/11/09.

We encourage all
students to prepare an abstract and poster based upon your
undergraduate (or graduate) research project or Senior Design
Project. Please submit abstracts to marcelo_anderson@ncsu.edu
or amy.lineberry@cagents.com
by 3/10/09. It is okay if your poster does not have a conclusion
because the work is in progress; just lay out the problem statement
and the approach to solving the problem.

A winner from both
graduate and undergraduate will be selected at the BTEC/ISPE Career
Fair on 3/20/0. Even if you do not win first place, you get the
opportunity to meet the companies at the BTEC/ISPE career fair and
will earn a partial scholarship to attend the ISPE annual event .
Additionally, company representatives from the BTEC Career Fair will
be selecting the best poster, therefore this is a great opportunity
to increase your exposure.

Posters
include the following:

Title
of the presentation
Names
of author(s) and affiliated organization(s)
Project
abstract (brief summary of project objective, methods, results, and
conclusions)
Background
Information
Project
objectives
Materials
and Methods

Key
dates

3/10
– abstract due

3/20-present
poster at BTEC/ISPE Career fair

For more information
please follow the below link

http://www.ispe.org/cs/students_section/poster_competition

Site of Annual Meeting

2009
Annual Meeting
8 - 11 November

Manchester
Grand Hyatt San Diego
One Market Place
San
Diego, CA 92101
Tel: +1-619- 232-1234
Fax:
+1-619-233-6464
www.manchestergrand.hyatt.com

Meeting #1 flier- Spring 09

2009-01-22T14:28:00.001-05:00

ISPE

NCSU
Student Chapter

1st
Meeting Schedule:

Thursday,
January 22nd, 2009 @ BTEC

(btec.ncsu.edu
– on Centennial next to EB2)

6:30-7:00:
Dinner and Networking (Chinese
food!)

7:00-7:30:
Presentation by Stewart McNaull Ph.D

Stewart
McNaull Ph.D is the Associate Director of Upstream Process
Development at Diosynth. He is an NC State graduate. Here are some
of the topics he will be covering:

Speaker
biography & career path as an NC State grad
Various
case studies in upstream development
Some
of the current Diosynth projects and technologies

Contact
Info:

Email Derek Gallo at
drgallo@ncsu.edu

Visit
Our Website: http://sites.google.com/site/ispencsuchapter/

Visit Our Facebook
Group: ISPE – NCSU Chapter

All majors are
welcome!

We want everyone who is
interested or wants to learn more about the pharmaceutical,
biopharmaceutical & biomanufacturing industries.

1/19/09

What courses will BTEC being offering?

2009-01-16T14:26:00.003-05:00

Summer courses are not posted yet, but here are what we anticipate offering.

1) Pilot courses for bionanotechnology and bioanalytical.

2) Several 3-day courses on

a) cGMP Fermentation Operations

b)Fermentation Engineering

C)Advanced Bioreactor Design

D)Development of Downstream Processes.

Please click this here to check the latest offerings.

How much are BTEC Courses?

2009-01-16T14:24:00.001-05:00

NCSU tuition schedule:

Fees are based upon the number of credit hours taken, residency status and if you are an undergraduate or graduate student.

Focus on Your Future

2009-01-16T09:38:00.002-05:00

1/24/09

This half day seminar is designed to provide undergraduate students with an overview of job search skills and information to help with exploring career options. Learn about the resources available to help you succeed with your transition from student to professional.

More information

ISPE Student Leadership Forum

2009-01-13T11:29:00.005-05:00

2009 ISPE Student Leadership Forum

Want to learn how to get a biopharma job?
Have Industry experts review your resume?
Learn how to prepare for an interview?
Learn how biopharma hires?
Make valuable industry contacts?
Ask your job/internship related questions?

Then this is a must attend event for you. Do NOT MISS this opportunity!!!

It is FREE.

LUNCH, snacks and gifts will be provided (Free).

You do not need to be a member of ISPE (though I do encourage you to join).

Location: McKimmon Center, 2/7/09 from 8:30-17:00.

You MUST RSVP, as space is limited. Please spread the word to your friends.

For more information click HERE

Question? Contact Marcelo, Winnell or any of the NCSU ISPE Student Leaders.

Join NCSU ISPE Facebook

Join BTEC Facebook

Join BTEC Linkedin Group

2009-01-06T12:05:00.005-05:00

Merck is offering a $5,000 Scholarship and a paid internship during the summer of 2009. This fellowship is available to students who were a Sophomore or Junior in the fall of 2008/2009 and are majoring in Chemical Engineering, other engineering or science disciplines. Please notify your friends of this opportunity as there will be more than one fellowship awarded.

FOLLOW THE BELOW LINKS FOR APPLICATION AND DETAILS

Brochure

Award Application

Terms

PLEASE NOTE THE DEADLINE IS 1/12/09. However the application will not take long to complete, so I encourage you to complete it.

To Apply

1) Complete Application form

2) Provide references

3) Provide a current resume

4) Provide copy of current official transcript

5) Submit profile on http://www.merck.com/careers/submit_resume/university.html Please see the E&T Application for intern positions corresponding to majors of interest.

We encourage you to take advantage of this important opportunity. If you have any questions, do not hesitate to contact me.

BTEC

ISPE Chapters Awarded for Extraordinary Student Chapter Support

2008-12-10T12:13:00.003-05:00

ISPE Chapters Awarded for Extraordinary Student Chapter Support!

The Chapter receiving the Grand Award in Student Programs has gone the extra mile for each of its eight Student Chapters and close to 200 Student Members. They performed exceptionally in management, activities, communications and, especially so, in membership growth. The Grand Award goes to Carolina-South Atlantic.

CASA Link

ISPE Link

Student Registration Link

BTEC Link

Happiness Can Spread Among People Like a Contagion, Study Indicates

2008-12-10T09:46:00.002-05:00

Happiness is contagious, spreading among friends, neighbors, siblings and spouses like the flu, according to a large study that for the first time shows how emotion can ripple through clusters of people who may not even know each other.

The study of more than 4,700 people who were followed over 20 years found that people who are happy or become happy boost the chances that someone they know will be happy. The power of happiness, moreover, can span another degree of separation, elevating the mood of that person's husband, wife, brother, sister, friend or next-door neighbor.

For full article click

CRO presense in North Carolina

2008-12-04T16:11:00.001-05:00

North Carolina is considered the top state in America for its growing concentration of companies providing contract research services for new-drug development, including clinical trials.

And if a core group of health-care specialists is successful as it carries its message off the East Carolina University campus eastward out of Greenville, Eastern North Carolina may become the new hot spot to reap some of the rewards of the state’s clinical-research growth.

North Carolina harbors one of the nation’s highest concentrations of contract research organizations (CROs). By 2006, the Old North State had a 22 percent greater concentration of people working in CROs and medical testing companies than the rest of the U.S. The sector grew 56.9 percent statewide from 2001 to 2006 alone. As of Dec.1, 2008, North Carolina boasted 104 such companies, employing 19,708 people.

For full article

NC Biopharma Investment Exceed $1 Billion

2008-11-20T15:43:00.003-05:00

Across the United States and around the world, officials are announcing huge investments to create bioscience clusters. The news is filled with government investments of hundreds of millions, or even a billion, dollars.

North Carolina started building its foundation 25 years ago when it established the North Carolina Biotechnology Center. While competing states are just starting out, North Carolina has invested more than $1.2 billion to the biosciences in just the past 10 years!

During the last decade North Carolina has committed:

$857 million into research and facilities
$135 million toward workforce training
$115 million via the North Carolina Biotechnology Center
$102 million in direct company incentives

According to a report from the Battelle Institute, North Carolina biotechnology has brought:

180,007 jobs
$9.4 billion in employment compensation
$45.8 billion in North Carolina business volume
$1.44 billion in taxes generated for state and local government
A thriving industry with 480 companies, employing 53,000

North Carolina: like nowhere else in the world for biotechnology

2009 ISPE Annual Life Science & Technology Show

2008-11-15T13:57:00.003-05:00

SAVE THE DATE

The 2009 ISPE Life Science & Technology Show will be at the RBC Center on April 1, 2009. Mark your calendars.

This is an event that is not to be missed.

CASA Chapter of ISPE

BTEC

Is BTEC education beneficial for Pharmacy?

2008-11-13T14:05:00.001-05:00

Students interested in Pharmacy
Often pharmacy students choose careers in Biomanufacturing (BMF), and vice versa, as they learn more about the other. Why? Because both Pharmacy and BMF positions are a good fit for people who they love hands-on work, working in teams, solving challenges and making a positive impact in people’s lives. If you intend to go into Pharmacy, it's essential to get some experience in manufacturings, you will have a better idea of multiple career fields, which can help cement in interest in one or the other. These careers are not mutually exclusive, so yes it is a wise move for students to learn BMF.

The Professional Pharmacist
Pharmacy is understanding drugs in-vivo kinetics. BMF is producing and purifying medicine from living cells. BMF gives the professional pharmacist a dramatically richer understanding of the therapeutics and therefore helps them do their job better. Yes without a doubt, a BTEC minor (or even a few classes) would help advance your pharmacy career as a professional.

For more information about the joint Campbell and NC State University masters program click here.

ISPE Student Meeting 13 Nov 2008

2008-11-09T13:17:00.005-05:00

BTEC and the NCSU ISPE Student Chapter are hosting

Todd Talerico, Senior Director for Process Development at AlphaVax Human Vaccines

“The Pros and Cons of Working for a Start-Up vs. a Large Operating Company”

The event begins at 6pm on 13 Nov 2008 at the BTEC facility on Centennial Campus. All visitors are welcome to attend.

Click here to visit the BTEC: Web page, Linkedin Group or Facebook Group

Event Flier

Key Contacts

2008-10-15T17:02:00.000-04:00

If you are an existing NC State University or BTEC student, please join our facebook group and our linkedin.com group.

Please learn more about BTEC at www.btec.ncsu.edu

The Golden LEAF Biomanufacturing Training and Eduation Center (BTEC)

Development Assoc Scientist 6092

Dev Engineer

NC EM Save the Date

Metabolon Seminar FLYER

Next week Wednesday & Thursday......

Clean and Green Seminar Registration

ACBJ study finds Raleigh among few markets to add jobs in 4Q

DISMAL DAYS IN DAYTON

Raleigh

Charlotte

Greensboro

Drug R&D spending surges in sinking economy

2009 ISPE Poster Competition

Local Winners Advance

Poster Competition Guidelines

Judging

Post-Judging

For More Information

Criteria Rating & Comments

Category A: Overall Appearance (20%)

Category B: Content (50%)

Category C: Presentation (30%)

Summary Comments

From Discovery to Fill and Finish

ISPE Webinar-Regulatory Affairs

ISPE_Poster_Competition_2009

Meeting #1 flier- Spring 09

What courses will BTEC being offering?

How much are BTEC Courses?

Focus on Your Future

ISPE Student Leadership Forum

Top 10 Biggest NC Biotech Stories of 2008

ISPE Chapters Awarded for Extraordinary Student Chapter Support

Happiness Can Spread Among People Like a Contagion, Study Indicates

CRO presense in North Carolina

NC Biopharma Investment Exceed $1 Billion

Contact:

North Carolina: like nowhere else in the world for biotechnology

2009 ISPE Annual Life Science & Technology Show

Is BTEC education beneficial for Pharmacy?

ISPE Student Meeting 13 Nov 2008

Key Contacts