What are the responsibilities and job description for the Senior Associate Scientist position at Sunrise Systems?
Job Description : % onsite required
Hybrid = days onsite week, days onsite the next week, subject to change based on the needs of the business.
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 and Quality 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 includes supporting the APQR, as required by regulatory agencies. The incumbent will support the CPV and APQR reports and approvals.
The organization being supported is a xx manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S. 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 % of time may be required.
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 Client standards and participating in best practice forums consistent with function responsibilities
Identify key Opex opportunities, using data driven evaluations
Working conditions :
The incumbent will be required to adhere to the current Client policies and procedures.
The incumbent will be required to gown to access classified manufacturing areas when needed.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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 (, 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
or more years of work experience in the biopharmaceutical or related industry
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
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