Oferta de trabajo: Senior Biostatistics Scientist

Job Title: Senior Biostatistics Scientist

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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.