Position: Cell Culture Process Dev't Group Leader

Rathbun, Sapir & Associates rathbun at sedona.net
Fri Jul 11 00:02:04 EST 1997


Cell Culture/Fermentation Process Development
Group Leader/Assoc. Director

We are seeking a PhD-level Cell Culture Engineer/Scientist experienced
in the development of large-scale processes for the production of
recombinant proteins in prokaryotic and eukaryotic cells for our
biopharmaceutical client company’s Process Development Dept.  This
person will be responsible for the development of processes for
production of materials for clinical trials under cGMP conditions;
and, he/she will supervise Process Cell Culture/Fermentation Staff

DESIRED PROFILE:
· Ph.D. in Chemical/Biochemical Engineering or equivalent.
· 4-7 years of industrial experience in:
Cell culture and, ideally,  microbial process development
Large-scale operations, minimum of 200 L
GMP production of clinical materials.

GENERAL JOB RESPONSIBILITIES:
· Design and carry out development strategies for large-scale cell
culture processes. 
· Develop scaleable and robust bioreactor processes; transfer these
processes to Manufacturing.
· Optimize bioreactor operating strategies to maximize product yield.
· Assist R&D staff in producing materials to support various research
projects.
· Supervise and train laboratory staff in experimental design,
interpretation, and planning.
· Maintain state-of-the-art expertise in technical areas and knowledge
in supporting technical areas. 
· Manage production of biopharmaceutical products for clinical trials
under cGMP conditions.
· Work with cell culture staff to prepare MPRs, SOPs and other
documents required for IND/BLA submission.
· Provide process requirements and engineering insight in the design
and construction of clinical manufacturing facilities.
· Assist in the validations of clinical manufacturing facilities,
including the design and implementation of process validation studies.
· Manage daily operations of Clinical Manufacturing Area; and work
with facility staff in plant maintenance.  Participate in department
and project team meetings; take responsibility for the cell culture
effort.

If you have an interest in this or other opportunities, please send us
your resume/CV as an Attached File to an email or send by mail/FAX to
RS&A to the attention of Ann G. Rathbun, Managing Director.  All
correspondence is held in strict confidence.


Rathbun, Sapir & Associates
P.O. Box 2337  Sedona, AZ 86339-2337 * USA
(520) 284-3360 Office  (520)284-3361 FAX
E-mail: rathbun@ sedona.net





More information about the Womenbio mailing list