Position: Cell Culture Manufacturing, Group Leader

Rathbun, Sapir & Associates rathbun at sedona.net
Fri Jul 11 00:02:30 EST 1997


Cell Culture Manufacturing, Group Leader

We are seeking a PhD-level Cell Culture Engineer/Scientist experienced
in the management of large-scale production of recombinant proteins
for the Group Leader position in our biopharmaceutical client
company’s new manufacturing facility.  This person will have ideally
gone through the start up phase of a new manufacturing facility and
must be familiar with the production of clinical materials.

DESIRED PROFILE:
· Ph.D. in Chemical/Biochemical Engineering or equivalent.
· 4-7 years of industrial experience in:
Cell culture and microbial process development
Large-scale operations, minimum of 200 L
GMP production of clinical materials.
· Supervisory experience of 3+ BS/MS level techs.
· Solid hands-on experience with equipment, instrumentation, facility
layout, etc.

GENERAL JOB RESPONSIBILITIES:
· Manage production of biopharmaceutical products for commercial use
under cGMP conditions.
· Work with Cell Culture staff to prepare MPRs, SOPs and other
documents required for BLA submission.
· Provide process requirements and engineering insight in the design
and construction of clinical manufacturing facilities.
· Assist in the validations of the manufacturing facilities.
· Manage daily operations of the Cell Culture area; and work with
facility staff in plant maintenance.
· Design and carry out process validation studies.
· Represent Manufacturing on project team meetings.  Take
responsibility for cell culture effort.
· Supervise reporting staff, conduct personnel training for
manufacturing operations, prepare performance appraisals, and recruit
staff.
· Participate in budget planning.  Communicate capital equipment
needs, facility needs, and staffing needs; and contact service
requirements.
· Participate in manufacturing operation and project team meetings.

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





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