Assistant/Associate Scientist

Spectraforce Technologies; Seattle (WA); On-site; USD 70,000 - 110,000; Full time

Job summary

Spectraforce Technologies is seeking an Assistant/Associate Scientist in Seattle, WA to support manufacturing of cell therapy products. The role focuses on testing, process improvement, and investigations at GMP facilities, with hands-on experiments and data analysis.

Responsibilities include aseptic processing, coordinating with analytical teams, documenting results, supporting process changes and validation studies, and ensuring regulatory compliance.

Qualifications

• BS in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences or relateddiscipline (as per posting).
• BS with minimum 2+ years of relevant experience, or MS with minimum 0+ years in biologic process/analytical development or manufacturing support.
• Excellent documentation skills with cGMP experience is a plus.
• Able to work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Experience in self-driven, results-oriented, fast-paced matrix environments.
• Strong problem-solving skills and excellent written and oral communication.

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 analytical group for timely delivery of process samples and data turnaround.
• Support manufacturing investigations, ensuring compliance with internal standards and regulatory requirements.
• Develop and execute manufacturing process changes and improvement activities, and author technical reports.
• Support process comparability and validation studies including planning, execution, and documentation management.

Skills

Cross-functional teamwork

Problem solving

Scientific writing

Time management

Education

BS in Biological Sciences or related

MS in Biological/related field

Tools

MS Office

R

JMP

Minitab

Job description

Position Title: Assistant/Associate Scientist Work Location: Seattle, WA Assignment Duration: 12 Months Work Schedule: Standard Work Hours; M-F Work Arrangement: 100% Onsite

Position Summary

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 cell therapy GMP manufacturing facilities.

Key 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

Qualification & Experience

• Degree in Biological Sciences, Chemical/Biomedical 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.
• 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.

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