Sr. Manager, Process Engineering - Process Monitoring (MSAT)
Company: Kite Pharma
Location: El Segundo
Posted on: June 26, 2022
Job Description:
Job DescriptionEveryone at Kite is grounded by one common goal -
curing cancer. Every single day, we seek to establish a direct line
between that purpose and our day-to-day work. Would you like to
join us in this mission?Kite is seeking a highly motivated
individual with biotechnology experience to work on process
monitoring support for the manufacturing of innovative T cell
therapies used for cancer treatment. As a Senior Manager for
Manufacturing Sciences and Technology (MSAT), you will lead the
process monitoring support team in commercial GMP manufacturing by
driving new systems, statistical techniques, predictive and
trending analysis that would provide oversight for GMP
manufacturing for Kite's engineered autologous T cell therapy
products.Responsibilities (include but are not limited to):
- Evaluate new technology and data systems for introduction into
GMP manufacturing
- Integrate data collection for data automation
- Develop and improve data-based process performance monitoring
systems
- Set up systems that consolidate the data across the
organization
- Introduce/integrate predictive modeling or other techniques for
a proactive approach
- Build advanced process monitoring analytics based on
multivariate analysis
- Translate the MSAT needs to develop tools, techniques, and
metrics, and dashboards for insights and data visualization
- Lead the process support team as the process monitoring
expertise for manufacturing site
- Monitor the site manufacturing processes to ensure a state of
control,
- Apply statistical process controls, control charts, data
trending as part of the process monitoring program
- Inform cross functional teams in root-cause investigations for
deviation resolution of complex problems
- Perform process data-driven deviation resolution and
improvement project
- Collaborate with technical and operational stakeholders, write
or review SOPs and other data collection related documents as
needed
- Ensure Data integrity
- Lead continuous improvement initiatives with high complexity
and impact to global manufacturing network, often impacting
commercial license.
- Lead deviation reduction initiatives based on collected CPV
process data
- Manage talented data analyst and data miners, including
organizing and prioritizing department goals & objectives
- Effectively motivate and mentor team members thereby enabling
their career growth
- Conduct technical and scientific trainingRequirements:
- BS or BA in Biochemical Engineering, Chemical Engineering,
Biotechnology, or equivalent with 8+ years of experience or
- MS in Biochemical Engineering, Chemical Engineering,
Biotechnology, or equivalent with 6+ years of experience
- Proficient with multivariate regression analyses, predictive
modelingPreferred Qualifications:
- Expert Knowledge of data management tools and statistical
process controls
- Experience in statistical analysis using JMP or Minitab
- Working knowledge of scientific, engineering principles as well
as data integrity
- Exercise sound judgment and flexibility while adapting to
rapidly changing priorities, challenging situations, and deadlines
needed to meet business objectives
- Knowledge of pharmaceutical manufacturing of biotechnology
products and process development
- Well versed in cGMP manufacturing and regulatory regulations
and requirements for pharmaceuticals and devices
- Ability to share complex principles of knowledge to others
(team member, stakeholder, external, or inspection) along with
strong technical writing abilities
- Experience working with or leading cross functional teams to
obtain project deliverables
- Working knowledge of scientific and engineering principles
- Certified Quality Engineer, Six Sigma Green Belt is a plusDoes
this sound like you? If so, please apply today!#LI-ML1#IND123
Keywords: Kite Pharma, Los Angeles , Sr. Manager, Process Engineering - Process Monitoring (MSAT), Executive , El Segundo, California
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