Senior Biostatistics Scientist

Job Title: Senior Biostatistics ScientistLike the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description. 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

Created: 2025-03-08