Assistant Scientist

Job Description

Job Summary:

• The Process Engineer will play a key role in ensuring successful manufacture of life-saving cell therapy products.
• The primary focus of the Process Engineer will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the cell therapy GMP manufacturing facility.
• The engineer will be part of a team tasked with determining the root cause of manufacturing investigations.
• This individual will design and execute experiments, evaluate data, and draft technical reports in support of improvement, investigations, and manufacturing process changes.
• The Process Engineer will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

Duties and Responsibilities:

• Design and 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.

Education and Experience:

• Degree in Biological Sciences, Chemical Engineering, Life Sciences or related discipline.
• 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.
• Experience executing investigations in support of commercial manufacturing.
• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Combination of experience in process development, MSAT and quality.
• Experience with cell therapy process development or manufacturing.
• Excellent documentation skills and attention to detail with cGMP experience a plus.

Knowledge, Skills and Abilities:

• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• 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.
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab).
• Operational excellence training/background.

Additional Job Requirements:

• Lab w/ blood & animal.
• Position Handles Hazardous Materials.