Associate Scientist

Job Title: Associate Scientist
Location: Summit, NJ
Type: Contract
Compensation: $40.00 - $47.55
Contractor Work Model: Onsite – onsite
Hours: Mon-Fri (normal business hours)

Overview
Leading pharmaceutical company looking for an experienced Associate Scientist. Ideal candidates should have at least an Associate degree with at least 1 year of relevant work experience, preferably in a health authority regulated environment.

Responsibilities

• Lead investigation reports in support of S12 CAR T operations, including root cause investigations, hypothesis testing, and interpretation of results
• Conduct thorough investigations such as Environmental Monitoring and deviations utilizing root cause analysis tools
• Interface closely with Quality Assurance teams and other functional organizations to ensure timely completion of investigations and reports
• Develop and propose effective CAPAs, develop CAPA plans, and verify their effectiveness
• Support health authority inspections and prepare necessary documentation
• Perform GEMBA walks with stakeholders to understand process steps and evaluate root causes
• Assess potential impacts and risks associated with process or product changes and develop mitigation strategies
• Initiate change control documentation and identify SMEs for impact assessments
• Provide technical support for manufacturing investigations, CAPAs, and change controls
• Support deviation investigations defense during audits and site inspections
• Employ lean manufacturing and six sigma principles to improve products, processes, and systems
• Serve as author or technical reviewer of departmental procedures as appropriate
• Support continuous improvement initiatives and foster a Right First Time mindset

Requirements

• Minimum Associate degree required; Bachelors Degree in science or engineering (preferably in Biochemistry, life sciences, or related engineering discipline)
• Minimum 1 year of relevant work experience, preferably in a health authority regulated environment
• Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T experience a plus)
• Technical writing skills and ability to collaborate effectively in cross-functional teams
• Knowledge of deviation investigations, root cause analysis, and CAPA processes
• Ability to support health authority inspections and prepare technical documentation
• Strong problem-solving skills, technical adeptness, and logical thinking
• Ability to manage timelines, prioritize tasks, and adapt to changing priorities
• Excellent communication skills to interact with management and cross-functional teams
• Experience with electronic Quality systems such as eQRMs or Infinity is a plus

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.