Senior Scientist-Biostatistics- Pharma (Hybrid- Summit, NJ)

Senior Scientist-Biostatistics- Pharma (Hybrid- Summit, NJ)

We are seeking a Senior Scientist-Biostatistics- Pharma for a global pharmaceutical client. The focus of this role is CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting and to 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 purpose of a CPV program is to provide evidence that a process is running under a state of control. The resource 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.

This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role in Summit, NJ.

Hybrid = 2 days onsite 1 week, 3 days onsite the next week. Global travel up to 10%.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities :

• Provide 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
• Identify key Opex opportunities, using data driven evaluations

Requirements :

Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the Senior Scientist-Biostatistics- Pharma (Hybrid- Summit, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion / belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation : $50 / hr. - $52.45hr.

LI-SW1

Salary : $50 - $52