Manufacturing Supervisor- Cell Culture
Company: Kelly
Location: Glendale
Posted on: May 16, 2022
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Job Description:
Title: Manufacturing Supervisor- Cell Culture Location: El
Segundo, CA Job Type: Direct-Hire, Full-Time (M-F 7am-4pm), On-Site
Job Summary: The Supervisor will play a critical role as the
primary point of contact for manufacturing, maintenance, and
banking of cell culture lines. Important aspects of this role
include excellent organization skills, flexibility, and the ability
to thrive in an efficient, highly interactive, goal-oriented team
environment, and leading with minimal supervision. As a team member
of the cell culture group, you will work to support cell and tissue
culture activities. The manufacturing skills and training include
expertise in mammalian cell culture, bioreactor process, aseptic
technique, cell culture techniques, sterile media preparation, and
clean room maintenance.
Job Responsibilities (Essential Functions): --- 30%- Supervise
operations of manufacturing facility in a cGMP environment. ---
15%- Investigate and resolve problems, identifying root cause, and
proposing process improvements through clear communication to
senior management. --- 5%- Bioreactor culture manufacturing
including fed-batch, and perfusion with both stainless and single
use cell culture technologies. --- 5%- Facilitate/lead technology
transfers from Process Development and participate in the CMO
interface as required. --- 5%- Provide necessary training and
ongoing coaching, discipline and recognition of direct staff,
including performing annual performance reviews. --- 5%- Generate
SOPs, MBRs, and EOPs for equipment and procedures used in routine
biologics manufacture. --- 5%- Execute production and resource
schedule against operational plan. --- 5%- Ensure performance of
all process steps specific to manufacturing (e.g. upstream,
packaging, shipping, support). --- 5%- Process monitoring,
including manipulation of databases, documents and/or spreadsheets
to support business reporting requirements. --- 5%- Complete the
final review of completed manufacturing documentation per
compliance standards and established timelines. --- 5%- Interact
with outside vendors and senior management. --- 5%- Collaborate
within department and cross-functionally to meet set objectives.
--- 5%- Take corrective action to bring about required changes
using change control procedures. --- Other duties as assigned Job
Education & Experience: --- BS in chemical engineering, genetics,
molecular biology, biotechnology, microbiology, biochemistry, or a
related field. --- Five (5) + years of relevant industry experience
or MS with relevant research experience. Job Knowledge, Skills, &
Abilities: --- Proven track record of running a cGMP facility. ---
Extensive experience running manufacturing-scale bioreactors
including setup, sampling, troubleshooting hardware and software.
--- A proven track record of accomplishments and timely delivery on
goals. --- Knowledge of mammalian cell culture and physiology. ---
Experience in aseptic processing, and cGMP manufacturing a plus.
--- Is well-versed in manufacturing and production, especially in
the area of biologicals. --- Complex Problem Solving: Identifying
complex problems and reviewing related information to develop and
evaluate options and implement solutions. --- Critical Thinking:
Using logic and reasoning to identify the strengths and weaknesses
of alternative solutions, conclusions or approaches to problems.
--- Judgment and Decision Making: Considering the relative costs
and benefits of potential actions to choose the most appropriate
one. --- Speaking: Presenting to others to convey information
professional and effectively. --- Deductive Reasoning: The ability
to apply general rules to specific problems to produce answers that
make sense. --- Demonstrated ability in cGMP bioprocess operations,
particularly upstream processes and aseptic technique. ---
Knowledge of cGMP guidelines or other good documentation processes.
--- Available to work a flexible schedule, including occasionally
coming in nights and weekends to support sampling of critical
processes. Note: For the purpose of this summary, occasionally is
used to represent up to 1/3 of the time given to the work day,
frequently represents 1/3 to 2/3 of the time and constantly
represents 2/3 or more of the time. Working Conditions
Physical:
Keywords: Kelly, Glendale , Manufacturing Supervisor- Cell Culture, Other , Glendale, Arizona
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