Associate Scientist, Cell Therapy Manufacturing Support (Onsite – Seattle, WA)

12-month contract (extensions possible) as a W2 employee of Stage 4 Solutions. 100% onsite in Seattle, WA. Health benefits and 401K offered.

About the role

Ensure successful manufacture of life-saving cell therapy products and support testing and implementation of operational improvements. Resolve manufacturing process investigations at the client’s cell therapy GMP manufacturing facilities. Contribute to manufacturing support studies, including investigational, process improvement, and process characterization studies. Execute experiments, evaluate data, draft technical reports, and support comparability and validation studies for regulatory filings.

Responsibilities

• Execute experiments in process development labs, including 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; author technical reports for process changes and improvements.
• Support process comparability and process validation studies, including planning, execution, and documentation management.
• Support technical experiments and analysis to enable decisions related to raw materials changes.
• Maintain flexibility with work schedule, including occasional weekends, early mornings, or evenings for cell culture maintenance.

Requirements

• BS degree with minimum 2+ years of relevant experience, or MS degree with 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
• Experience with cell therapy process development or manufacturing.
• Aseptic manufacturing or process development experience.
• Data analysis experience, including proficiency with MS Office products and working knowledge of statistical software (R, JMP, Minitab).
• Excellent documentation skills and attention to detail; cGMP experience a plus.
• Strong scientific and technical writing with excellent oral communication skills.
• Degree in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences, or related discipline.

Preferred Qualifications

• Experience supporting investigations in support of commercial manufacturing.
• Experience with commercial product support, including post-marketing commitments, ongoing validation, and comparability.
• Combination of experience in process development, MSAT, and quality.
• Operational excellence training/background.

Pay

$45/hr. - $47.55/hr.

Schedule

40 hours per week.