Job Information
Sokol Materials & Services Senior Associate Scientist in Skillman, New Jersey
Senior Associate Scientist
Job Location
Summit, NJ
Workspace
Hybrid
Target Hiring Date
March 2025
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.
Requirements
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 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 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
WORKING CONDITIONS:
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.
This role may involve working in an office, laboratory, or manufacturing area.
Must be able to work in gowning attire within a controlled environment for extended periods.
Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.
Must be able to lift up to 15 pounds as needed.
About the Role
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.
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.
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
Identify key Opex opportunities, using data-driven evaluations
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About the Company
Join Sokol GxP Services – Where Innovation Meets Integrity!
Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget, a 401K* program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!
Let’s shape the future of life sciences together!
All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.
Equal Opportunity Employer Statement:
Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
*Relocation support will be determined on a case-by-case basis.
**Our 401K program is set to launch in the 2025 fiscal year.
By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.
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