Senior Associate Scientist

Job Title:

Senior Associate Scientist

Department:

Global Product Development and Supply

Location:

Summit West, NJ

Job Type:

Hybrid

Reporting Structure:

Client, SOKOL

Effective Date:

03/17/2025

Pay range:

$45 - $50 per hour

Work authorization:

Applicants must have the legal right to work in the United States without requiring sponsorship.

Corp-to-Corp (C2C) arrangements are not accepted.

ABOUT US:

SOKOL GxP Services is a rapidly expanding provider of Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), and a full suite of GxP services tailored to the pharmaceutical, biotechnology, cell therapy, and medical device industries. Our mission is to help clients achieve regulatory compliance while upholding the highest standards of product quality and safety.

Our customized solutions are designed to guide clients through complex regulatory landscapes, enhancing the efficiency and compliance of their GxP processes. At SOKOL, we’re committed to empowering our clients with the expertise and precision needed to confidently meet and exceed industry standards.

Crafting GxP Excellence!

JOB DESCRIPTION:

The Senior Scientist of Biostatistics is a member of the MSAT team, with a focus on CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting.

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. The 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. travel up to 10% of the time may be required within the US.

DUTIES AND 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

EDUCATION:

• Bachelor’s Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred
• 8 or more years of work experience in biopharmaceutical or related industry
• 8 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

QUALIFICATIONS:

• 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 is preferred.
• Summary Report creation/Review in support of CPV (Continuous Process Verification) and APQR (Annual Product Quality Review).
• 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 in 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

What We Offer:

Join SOKOL GxP Services! We partner with top pharmaceutical and biotech companies to deliver exceptional GxP and compliance services. At SOKOL, we’re dedicated to fostering diversity, supporting local talent, and building strong community connections to connect the best-qualified candidates with our clients. Be part of a dynamic team where you can shape the future of life sciences and advance your career in a collaborative, innovative environment. Our culture promotes growth and inclusivity, with a commitment to professional development and competitive benefits, including:

• Health benefits
• PTO
• Holiday pay
• Volunteer hours
• Relocation assistance*
• 401K** program
• Professional development opportunities
• Employee referral program

*Relocation support will be determined on a case-by-case basis.

**Our 401K program is set to launch in the 2025 fiscal year.

Equal Opportunity Employer Statement:

SOKOL GxP Services is an equal-opportunity employer. All qualified applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law.