What are the responsibilities and job description for the Senior Biostatistics Scientist position at System One?
Job Title: Senior Biostatistics Scientist
Location: Summit West, NJ
Hours/Schedule: Mon - Fri, Business Hours/ Hybrid
Type: Contract
Responsibilities
Requirements
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
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
