Development Assoc Scientist 6092

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

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:

 

1. Evaluate and develop methodologies for viral replicon particles (VRP) purification including, but not limited to filtration and chromatography processes.
2. Design, test, and implement strategies for aseptic cell harvesting, washing and concentration.
3. Optimize and implement electroporation techniques and equipment for cell transfection.
4. Develop VRP harvest protocols using filtration.
5. Support scale-up activities.
6. Collaborate in the production of VRP in support of development activities.
7. Support pilot lot and manufacturing activities as well as the transfer of large scale processes into manufacturing.
8. 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

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

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......

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

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