What are the responsibilities and job description for the Biostatistician - Contract - 50% onsite - Summit, NJ position at Montek System?
Job Details
Biostatistician
Summit, NJ
50% onsite
Duration: 12 months
Duties/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 BMS standards and participating in best practice forums consistent with function responsibilities
Identify key Opex opportunities, using data driven evaluations
Qualifications Specific Knowledge, Skills, Abilities:
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
Education, Experience, Licenses, Certificates:
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
