Senior Biostatistics Scientist
Company: Joul--
Location: Summit
Posted on: March 8, 2025
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Job Description:
Job Title: Senior Biostatistics Scientist
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Location: Summit West, NJ
Hours/Schedule: Mon - Fri, Business Hours/ Hybrid
Type: Contract
Responsibilities Provides support to maintain the site Statistical
Process Control (SPC) program, manufacturing performance trending
and reporting.
Provide multivariate analysis (MVA) modeling for improved process
understanding and robustness
Continuously monitor CPV parameters, evaluate Statistical Alert
Events (SAEs), and take needed actions.
Collaborate and support investigations by providing data and
analysis
Meet CPV and APQR timelines
Establish and support predictive process monitoring analytics
Supporting any proactive initiatives or investigations related to
drift in product performance
Represent the site MSAT CPV team in cross-functional forums
Performing review and approval of site documents within the scope
of CPV and APQR
Ensuring safe and compliant cGMP operations and maintaining
permanent inspection readiness; actively supporting regulatory
inspections
Interacting with other teams including Operational Excellence, PMO
(Project Management Organization), site MSAT, Global MSAT, Quality
Assurance, Process Support/Engineering and Manufacturing Support,
Manufacturing Operations, Supply Chain Operations
Staying current with industry trends and company standards and
participating in best practice forums consistent with function
responsibilities
Identify key Opex opportunities, using data driven evaluations
Requirements Excellent knowledge of evaluating data using
statistics and statistical tools, to make data driven
decisions.
Proficiency in major statistical software packages and programming
languages (e.g., R, JMP, MINITAB, or SAS). JMP software
preferred.
Must be detail oriented and proven track record of impeccable time
management, to meet timelines.
Possess strong verbal/written communication skills to enable
working with internal/external parties and/or collaborating with
cross-functional teams.
Expert knowledge of cGMP's and multi-national
biopharmaceutical/cell therapy regulations.
Experience of facility/clean room design, process, equipment,
automation, and validation.
Experience with the start-up, validation, and licensure of new
biopharmaceutical manufacturing facilities.
Hands-on experience with single-use technologies, closed systems,
and cold chain/cryogenic technologies.
Experience with Operational Excellence and Lean Manufacturing
Bachelor's Degree required (science or engineering is preferred);
Graduate or higher-level Degree is preferred
8 or more years of work experience in the biopharmaceutical or
related industry
8 or more years of manufacturing support or related experience in
the biopharmaceutical industry
Experience in CPV and/or APQR reporting preferred. May be
substituted for relevant experience in monitoring/trending
performance of Quality attributes
Experience in cell therapy, biologics, or vaccine
manufacturing/support required
Experience with Operational Excellence and Lean Manufacturing is a
plus
Benefits
System One offers eligible employees health and welfare benefits
coverage options, including medical, dental, vision, spending
accounts, life insurance, voluntary plans, and participation in a
401(k) plan.
Ref: #568-Clinical
Keywords: Joul--, New York , Senior Biostatistics Scientist, Other , Summit, New York
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