Biostatistician

Location: Summit NJ - Hybrid Term: 6+ Months Title: BIOSTATISTICIAN/ SENIOR SCIENTISTBrief Job Description:The Senior Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting.Position Summary:The incumbent will support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply.The Incumbent will trend CPV parameters, including but not limited to Manufacturing process parameters andQuality Control Release attributes for the MSAT organization, to support the Summit, NJ Cell Therapy facility.The purpose of a CPV program is to provide evidence that a process is running under a state of control. The incumbent will monitor/trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines. The CPV program includessupporting the APQR, as required by regulatory agencies. The incumbent will support the CPV and APQR reports and approvals.The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.This position is based in Summit, NJ. Global travel up to 10% of time may berequired.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 processunderstanding 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 inproduct performance• Represent the site MSAT CPV team in cross-functional forums• Performing review and approval of site documents within the scope of CPVand APQR• Ensuring safe and compliant cGMP operations and maintaining permanentinspection readiness; actively supporting regulatory inspections• Interacting with other teams including Operational Excellence, PMO (ProjectManagement Organization), site MSAT, Global MSAT, Quality Assurance,Process Support/Engineering and Manufacturing Support, ManufacturingOperations, Supply Chain Operations• Staying current with industry trends and Client standards and participating inbest practice forums consistent with function responsibilities• Identify key Opex opportunities, using data driven evaluationsWorking conditions:• The incumbent will be required to adhere to the current Client policies andprocedures.• The incumbent will be required to gown to access classified manufacturingareas when needed.• This job description is intended to describe the general nature and level ofwork being performed by the person assigned to this position. The primaryduties and responsibilities are intended to describe those functions that areessential to the performance of this job.• This job description does not state or imply that the above are the only dutiesand responsibilities assigned to this position. There are other duties andresponsibilities that are considered incidental or secondary to the overallpurpose of this job. Employees holding this position will be required toperform any other job-related duties as requested by management.Qualifications Specific Knowledge, Skills, Abilities:• Excellent knowledge of evaluating data using statistics and statistical tools, tomake 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 timemanagement, to meet timelines.• Possess strong verbal/written communication skills to enable working withinternal/external parties and/or collaborating with cross-functional teams.• Expert knowledge of cGMP's and multi-national biopharmaceutical/celltherapy regulations.• Experience of facility/clean room design, process, equipment, automation,and validation.• Experience with the start-up, validation, and licensure of newbiopharmaceutical manufacturing facilities.• Hands-on experience with single-use technologies, closed systems, and coldchain/cryogenic technologies.• Experience with Operational Excellence and Lean ManufacturingEducation, Experience, Licenses, Certificates:• Bachelor's Degree required (science or engineering is preferred); Graduateor higher-level Degree is preferred• 8 or more years of work experience in the biopharmaceutical or relatedindustry• 8 or more years of manufacturing support or related experience in thebiopharmaceutical industry• Experience in CPV and/or APQR reporting preferred. May be substituted forrelevant experience in monitoring/trending performance of Qualityattributes• Experience in cell therapy, biologics, or vaccine manufacturing/supportrequired• Experience with Operational Excellence and Lean Manufacturing is a plusAdditional EEO:"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."

Created: 2025-03-09