Our client, a leading pharmaceutical company, is hiring a Senior Associate Scientist, on a contract basis.
Job ID #: 81828
Work Location:
Summit, NJ – Hybrid role, 50% on site
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 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.
Education/Experience:
- Bachelors Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred
- 8 years of work experience in the biopharmaceutical or related industry
- 8 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
Knowledge/Skills:
- 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 cGMPs 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
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
Pay Range: $48-$52/hr