Assistant Scientist

Job Title

Assistant Scientist

12 months on W2 Contract (Possible extension based on performace)

Summit, NJ

Onsite

Mon-Fri(normal business hours) with occasional requirement to work weekends as needed.

The Assistant Scientist will play a key role in ensuring successful manufacture of life-saving cell therapy products. The primary focus of the Assistant Scientist will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the Client cell therapy GMP manufacturing facilities. 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.

• 1+ years of cell culture experience
• 1+ years of laboratory experience
• 1+ years Aseptic processing experience
• Required Bachelor s Degree in Biological Sciences field, Chemical/Biomedical/Bio
  - Engineering field, or Life Sciences field.

• 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

• 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.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• 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.

• 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