Assistant Scientist

Assistant Scientist
Location: Summit, NJ
Type: Contract
Compensation: $30.00 - $35.50 hourly

Full Job Description :
The Assistant Scientist will play a key role in ensuring successful manufacture of life-saving cell therapy products. The Assistant Scientist will be part of a team tasked with completing manufacturing support studies, including investigational, process improvement and process characterization studies. This individual will primarily execute experiments, evaluate data, and draft technical reports. The Assistant Scientist will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

Primary Responsibilities:

• Execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment.
• Summarize experimental data and aid in analysis to draw conclusions.
• Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.
• Support process comparability and process validation studies including planning, execution, and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes.
• Flexibility with work schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required

Required Qualifications:

• Degree in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences or related discipline.
• Required BS degree with minimum of 2+ years of relevant experience, or MS degree with minimum 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
• Excellent documentation skills and attention to detail with cGMP experience a plus.
• Excellent problem-solving skills.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing with excellent oral communication skills.

Preferred Qualifications:

• Experience with cell therapy process development or manufacturing
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
• Experience supporting investigations in support of commercial manufacturing
• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability
• Combination of experience in process development, MSAT and quality.
• Operational excellence training/background

System One, and its subsidiaries including Joule, ALTA IT Services, 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: #568-Clinical