What are the responsibilities and job description for the Senior Scientist position at Fortira Inc.?
Role : Senior Scientist
Location : Summit West, NJ - Hybrid
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 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.
Top Must Have's for candidate to be Considered for this role :
1. Excellent knowledge of evaluating data using statistics and statistical tools, to make data driven decisions.
2. Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
3. Summary Report creation / Review in support of CPV (Continuous Process Verification) and APQR (Annual Product Quality Review).
4. Must be detail oriented and proven track record of impeccable time management, to meet timelines.
5. Possess strong verbal / written communication skills to enable working with internal / external parties and / or collaborating with cross-functional teams.
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 BMS standards and participating in best practice forums consistent with function responsibilities
- Identify key Opex opportunities, using data driven evaluations
Working conditions :
Qualifications Specific Knowledge, Skills, Abilities :
biopharmaceutical manufacturing facilities.
